Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01765153
First received: November 30, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

The objective of the study was to determine the efficacy of two forms of physical therapy training, one emphasizing precise, visually guided walking over obstacles and on targets (Precision Training), the other emphasizing mass practice of walking on a treadmill (Endurance Training). The hypothesis was that visually guided training (Precision) may be especially efficacious because it engages the motor cortex, whose input may facilitate improvements in functional walking. Participants are individuals with a chronic (≥7 months post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would preclude participation in an intensive training program. A randomized, single-blinded, cross-over design was used to randomly allocate participants to start with Precision or Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed by a 2-month rest period, identified as Rest Period I. Participants then returned for 2-months of training in the other method, identified as Training Phase II, followed by another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence, as well as depression were obtained at least 3 times before any training, then monthly thereafter. Electrophysiological measures were taken before and after each phase of training and period of rest. Change scores were used to determine how each phase of training and rest influenced the scores (see below).


Condition Intervention
Spinal Cord Injury
Behavioral: Endurance training in walking
Behavioral: Precision walking training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion [ Time Frame: Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study) ] [ Designated as safety issue: No ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures for all 7 items.


Secondary Outcome Measures:
  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 1 month of Training Phase I [ Time Frame: Change from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. In addition, an assistance category is assigned based on the walking aids used. A composite (single) score is obtained by combining the two measures.

  • Change in 6 Minute Walk test (6MWT) at 1 month of Training Phase I [ Time Frame: Change from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    Participants walk for as far as possible in 6 min along a 25m hallway.

  • Change in 6 minute walk test (6MWT) at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    Participants walk for as far as possible in 6 min along a 25m hallway.

  • Change in 6 minute walk test (6MWT) at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    Participants walk for as far as possible in 6 min along a 25m hallway.

  • Change in 6 minute walk test (6MWT) at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    Participants walk for as far as possible in 6 min along a 25m hallway.

  • Change in 6 minute walk test (6MWT) at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    Participants walk for as far as possible in 6 min along a 25m hallway.

  • Change in 6 minute walk test (6MWT) at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    Participants walk for as far as possible in 6 min along a 25m hallway.

  • Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at 1 month of Training Phase I [ Time Frame: Change score from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed.

  • Change in 10 metre walk test at a self-selected speed [10MWT(ss)] at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a self-selected speed [10MWT(ss)] at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    Participants walk along a 14m path along a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at fastest safe speed [10MWT(f)] at 1 month Training Phase I [ Time Frame: Change from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a fast speed [10MWT(f)] at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a fast speed [10MWT(f)] at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a fast speed [10MWT(f)] at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a fast speed [10MWT(f)] at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed.

  • Change in 10 meter walk test at a fast speed [10MWT(f)] at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    Participants walk as quickly as they able to safely walk along a 14m path on a smooth floor, in which the middle 10 m is timed.

  • Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 1 month of Training Phase I [ Time Frame: Change from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.).

  • Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.).

  • Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.).

  • Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.).

  • Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.).

  • Change in Walking Index for Spinal Cord Injury version II self-selected (WISCI-II ss) at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk in their self-selected way (i.e., with assistance, walking aids, braces ... etc.).

  • Change in Walking Index for Spinal Cord Injury version II maximum (WISCI-II max) at 1 month of Training Phase I [ Time Frame: Change from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale.

  • Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale.

  • Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale.

  • Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale.

  • Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale.

  • Change in Walking Index for Spinal Cord Injury version II maximum [WISCI-II (max)] at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    Participants are scored from 0 to 20 based on how they perform a 10m walk when challenged progressively to use less supportive walking aids according to the protocol of the WISCI-II scale.

  • Change in Activities-specific Balance Confidence Scale (ABC) at 1 month of Training Phase I [ Time Frame: Change from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    A survey with 16 questions participants answer using a pen/paper format.

  • Change in Activities-specific Balance Confidence Scale (ABC) at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    A survey with 16 questions participants answer using a pen/paper format.

  • Change in Activities-specific Balance Confidence Scale (ABC) at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    A survey with 16 questions participants answer using a pen/paper format.

  • Change in Activities-specific Balance Confidence Scale (ABC) at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    A survey with 16 questions participants answer using a pen/paper format.

  • Change in Activities-specific Balance Confidence Scale (ABC) at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    A survey with 16 questions participants answer using a pen/paper format.

  • Change in Activities-specific Balance Confidence Scale (ABC) at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    A survey with 16 questions participants answer using a pen/paper format.

  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 1 month of Training Phase I [ Time Frame: Change from Baseline I to 1 month of Training Phase I ] [ Designated as safety issue: No ]
    A survey filled out by participants using a pen/paper format.

  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    A survey filled out by participants using a pen/paper format.

  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    A survey filled out by participants using a pen/paper format.

  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 1 month of Training Phase II [ Time Frame: Change from Baseline II to 1 month of Training Phase II ] [ Designated as safety issue: No ]
    A survey filled out by participants using a pen/paper format.

  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    A survey filled out by participants using a pen/paper format.

  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    A survey filled out by participants using a pen/paper format.

  • Change in Manual muscle test (MMT) at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated.

  • Change in Manual muscle test (MMT) at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated.

  • Change in Manual muscle test (MMT) at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated.

  • Change in Manual muscle test (MMT) at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    The strength of major muscle groups in the lower extremities, bilaterally (8 groups/side), is tested manually using the standard manual muscle test used in clinics, and a composite single score is calculated.

  • Change in cutaneomuscular reflexes at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are recorded in standing.

  • Change in cutaneomuscular reflexes at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.

  • Change in cutaneomuscular reflexes at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.

  • Change in cutaneomuscular reflexes at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.

  • Change in Transcranial magnetic stimulation (TMS) at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: Yes ]
    Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.

  • Change in Transcranial magnetic stimulation (TMS) at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: Yes ]
    Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.

  • Change in Transcranial magnetic stimulation (TMS) at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: Yes ]
    Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.

  • Change in Transcranial magnetic stimulation (TMS) at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: Yes ]
    2 months of Training Phase 2

  • Change in Electromyography during treadmill walking at 2 months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ] [ Designated as safety issue: No ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.

  • Change in Electromyography during treadmill walking at the end of 2 months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ] [ Designated as safety issue: No ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.

  • Change in Electromyography during treadmill walking at 2 months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ] [ Designated as safety issue: No ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.

  • Change in Electromyography during treadmill walking at the end of 2 months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ] [ Designated as safety issue: No ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.


Enrollment: 21
Study Start Date: March 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endurance first
Participants to start with Endurance Training. Each phase of training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Percision Training (2 mo), followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter.
Behavioral: Endurance training in walking
Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.
Other Names:
  • Treadmill walking training
  • Body-weight supported treadmill training
Behavioral: Precision walking training
Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.
Other Name: Skill walking training
Experimental: Precision first
Participants to start with Precision Training. Each phase of training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Endurance Training (2 mo), followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter.
Behavioral: Endurance training in walking
Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.
Other Names:
  • Treadmill walking training
  • Body-weight supported treadmill training
Behavioral: Precision walking training
Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.
Other Name: Skill walking training

  Hide Detailed Description

Detailed Description:

PARTICIPANTS: Inclusion criteria: 1) SCI from trauma or other stable lesions, 2) injury occurred ≥ 7 mo prior, 3) able to walk independently at least 5 m with a walking aid and/or braces, 4) injury level between C1-L1, 5) able to give informed consent, 6) able to attend training sessions 5x/week. Exclusion criteria: 1) head injury, 2) cognitive or musculoskeletal impairments that preclude participation in walking training, 3) seizures or implants in the head that would preclude participation in experiments using transcranial magnetic stimulation (TMS).

INTERVENTIONS:

Precision Training. Training was performed on a 15 m long track. The track contained obstacles and targets. Obstacles were made of Styrofoam blocks of 3 cm height each, varying in width from 4 cm to 20 cm in divisions of 4 cm increments (which must be cleared without touching), and targets were made of fabric circles, ranging in diameter from 7-10.5 cm (which must be totally obscured by their foot). The difficulty of the track was designed to have the participant achieve ~80% success. The emphasis was on accuracy, not speed.

Endurance Training. The aim of this training was mass practice. Participants walked on the treadmill, with body-weight support (BWS) and manual assistance if needed. The treadmill speed was initially set to be faster than their over ground walking speed as measured by the 10 MWT(ss). Participants were encouraged to walk for as far and as fast as possible with minimal rest periods. Progression involved reducing manual assistance and BWS, increasing walking speed and distance, while reducing rest breaks.

In both phases of training, a research assistant or volunteer recorded training parameters each session. The number of steps executed was measured with a step counter (StepWatch, Orthocare Innovations, USA), which was confirmed to be accurate with simultaneous manual counting prior to its use, and periodically during training sessions. The heart rate before and immediately after each bout of walking was measured with a heart rate monitor (Polar FT7, Polar, Canada). The total time, distance and walking speed for each walking bout was recorded.

MEASURES:

Measures were taken prior to all training at baseline (called Baseline I) and the end of each of the following intervals - one month of Training Phase I, two months of Training Phase I, one month of Rest Period I, two months of Rest Period I, one month of Training Phase II, two months of Training Phase II, one month of Rest Period II, two months of Rest Period II. To measure changes during the second phase of training, the baseline was the average of the one and two month measures of Rest Period I, henceforth called Baseline II.

STATISTICAL ANALYSIS: To determined if one type of training was superior to the other, we compared the change scores (i.e., post-training score minus pre-training score) from each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. Since individuals with high compared to low walking function may respond to the training differently, we divided individuals based on their pretraining walking speed as measured by the 10 MWT(ss) (i.e., > or < 0.5 m/s). The change scores from each of these groups of individuals were then compared for each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. To determine the time course for obtaining a treatment effect, we compared the change scores for the first month (i.e., outcome measure at end of 1 mo minus baseline) versus the second month (outcome measure at end of 2 mo minus at end of 1 mo) of training for each type of training, using a standard t-test or a Mann-Whitney U test, as appropriate. Retention of gains was followed for 2 months after each type of training. The outcome measures at the end of the 2 month rest period were compared to the measures immediately after the training, for individuals that made improvements greater than the standard error of measurement for each measure, using a paired t-test or Wilcoxon signed-rank test, as appropriate.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • spinal cord injury equal or more than 7 months prior
  • able to walk at least 5 meters independently (can use walking aids and braces)
  • injury level between C1 and L1
  • able to give informed consent
  • able to attend training sessions 5x/week

Exclusion Criteria:

  • head injury
  • cognitive of musculoskeletal impairments that preclude participation in walking training
  • seizures or implants in the head that would preclude participation in experiments with transcranial magnetic stimulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765153

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jaynie Yang, PhD University of Alberta
Principal Investigator: Monica Gorassini, PhD University of Alberta
  More Information

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01765153     History of Changes
Other Study ID Numbers: Pro00003873
Study First Received: November 30, 2012
Last Updated: January 8, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

Keywords provided by University of Alberta:
physical therapy
rehabilitation
neuroplasticity

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014