Clinical trial NCT00610974: Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study
Official title: Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor-incomplete Spinal Cord Injury
Keywords: Spinal cord injury
walking
gait training
body-weight supported treadmill training
rehabilitation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.
timeFrame: 6 months
Secondary outcomes:
measure: Average activity level per day measured before, after, 1-month after, and 6-months after training
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Human Locomotion Lab, University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Tania Lam, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Janice J. Eng, Ph.D
role: STUDY_DIRECTOR
References:
citation: Lam T, Pauhl K, Ferguson A, Malik RN; BKin; Krassioukov A, Eng JJ. Training with robot-applied resistance in people with motor-incomplete spinal cord injury: Pilot study. J Rehabil Res Dev. 2015;52(1):113-29. doi: 10.1682/JRRD.2014.03.0090.