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

Not Applicable

Completed

• Conditions: Motor-incomplete Spinal Cord Injury
• Interventions: Behavioral: Body-weight supported treadmill training

• Registration Number: NCT00610974
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Study Start: 2008-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Body-weight supported treadmill training	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.
2	Body-weight supported treadmill training	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average activity level per day measured before, after, 1-month after, and 6-months after training	6 months

Trial Locations

Locations (1)

Human Locomotion Lab, University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada