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Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00610974
First received: January 28, 2008
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

The research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking.


Condition Intervention
Motor-incomplete Spinal Cord Injury
 Behavioral: Body-weight supported treadmill training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average activity level per day measured before, after, 1-month after, and 6-months after training [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking.
 Behavioral: Body-weight supported treadmill training
BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
Experimental: 2
One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking.
 Behavioral: Body-weight supported treadmill training
BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.

Detailed Description:

Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In total, 20 participants will be recruited and randomly assigned to one of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to the leg movements while walking. Therapy for both groups will take place 3 times/week for 12 weeks. During each session, participants will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but participants should complete 45 minutes of walking per session.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
  2. 19 to 65 years of age
  3. use of standing or walking as part of typical activities of daily living
  4. controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study

Exclusion Criteria:

  1. lesion below 11th thoracic level (lower motoneuron injury)
  2. weight greater than 300 lbs or height greater than 6'1"
  3. femur length <35 cm or >47 cm and body weight >150 kg
  4. cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
  5. existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness
  6. existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30)
  7. participation in rehabilitation therapy or other research study with exercise or mobility outcomes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610974

Locations
Canada, British Columbia
Human Locomotion Lab, University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Tania Lam, Ph.D University of British Columbia
Study Director: Janice J. Eng, Ph.D University of British Columbia
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00610974     History of Changes
Other Study ID Numbers: H07-01394
Study First Received: January 28, 2008
Last Updated: August 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Spinal cord injury
walking
gait training
body-weight supported treadmill training
rehabilitation

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

ClinicalTrials.gov processed this record on May 21, 2013