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

Motor-incomplete Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610974
• Other study ID #: H07-01394
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: September 24, 2014
• Start date: March 2008
• Est. completion date: July 2011

Study information

• Verified date: September 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Motor-incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Human Locomotion Lab, University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.		6 months	No
Secondary	Average activity level per day measured before, after, 1-month after, and 6-months after training		6 months	No