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

University of British Columbia

Status: Completed

Conditions: Motor-incomplete Spinal Cord Injury

Treatments: Behavioral: Body-weight supported treadmill training

Study type: Interventional

Funder types: Other

Identifiers

NCT00610974

H07-01394

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Behavioral: Body-weight supported treadmill training

Behavioral: Body-weight supported treadmill training

2

Experimental group

Description:

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.

Treatment:

Behavioral: Body-weight supported treadmill training

Behavioral: Body-weight supported treadmill training