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Clinical Trials/NCT00610974
NCT00610974
Completed
Not Applicable

Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study

University of British Columbia1 site in 1 country15 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Motor-incomplete Spinal Cord Injury
Sponsor
University of British Columbia
Enrollment
15
Locations
1
Primary Endpoint
The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
July 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • lesion below 11th thoracic level (lower motoneuron injury)
  • weight greater than 300 lbs or height greater than 6'1"
  • femur length \<35 cm or \>47 cm and body weight \>150 kg
  • cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
  • 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
  • existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30)
  • participation in rehabilitation therapy or other research study with exercise or mobility outcomes

Outcomes

Primary Outcomes

The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.

Time Frame: 6 months

Secondary Outcomes

  • Average activity level per day measured before, after, 1-month after, and 6-months after training(6 months)

Study Sites (1)

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