Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01087918
First received: March 15, 2010
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

The purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.


Condition Intervention Phase
Spinal Cord Injury
Device: RAGT
Other: Strength Training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 10 Meter Walking at Preferred Speed [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.

  • 10 Meter Walking at Maximal Speed [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.


Secondary Outcome Measures:
  • Walking Index for Spinal Cord Injury II [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.

  • Berg Balance Scale [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.

  • Spinal Cord Independence Measure III [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.

  • Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.

  • Manual Muscle Test of the Lower Extremity [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.

  • Pain on a Visual Analogue Scale [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.

  • Response Time of the Lower Extremities [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.

  • Falls Efficacy Scale [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.

  • Figure of Eight Test [ Time Frame: Baseline, after intervention (4 weeks) ] [ Designated as safety issue: No ]
    The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.


Enrollment: 9
Study Start Date: July 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First RAGT, then strength training
16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
Device: RAGT
16 sessions / 4 times/week / 45 minutes Lokomat training
Other: Strength Training
16 sessions / 4 times/week / 45 minutes lower extremity strength training
Experimental: First strength training, then RAGT
16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
Device: RAGT
16 sessions / 4 times/week / 45 minutes Lokomat training
Other: Strength Training
16 sessions / 4 times/week / 45 minutes lower extremity strength training

Detailed Description:

Although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. In this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Time since lesion > 1 year
  • Outdoor mobility SCIM III < 5
  • Stable walking capacity

Exclusion Criteria:

  • participating on other training studies
  • osteoporosis
  • psychiatric diseases
  • epilepsia
  • body weight > 130 kg
  • cardiac pacemaker
  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: NCT01087918

Locations
Switzerland
Balgrist University Hospital
Zurich, Switzerland, 8008
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Huub van Hedel, PhD University of Zurich
  More Information

Additional Information:
No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01087918     History of Changes
Other Study ID Numbers: EK-21/2008, CLI006/2 extension
Study First Received: March 15, 2010
Results First Received: May 10, 2012
Last Updated: October 22, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
ASIA C and D

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 29, 2014