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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00610974
Enrollment
15
Registered
2008-02-08
Start date
2008-03-31
Completion date
2011-07-31
Last updated
2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor-incomplete Spinal Cord Injury

Keywords

Spinal cord injury, walking, gait training, body-weight supported treadmill training, rehabilitation

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.

Interventions

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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Average activity level per day measured before, after, 1-month after, and 6-months after training6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026