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

NCT ID: NCT00610974

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-07-31

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.

Conditions

Motor-incomplete Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

2

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.

Group Type: EXPERIMENTAL

Body-weight supported treadmill training

Intervention Type: BEHAVIORAL

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.

1

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.

Group Type: ACTIVE_COMPARATOR

Body-weight supported treadmill training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania Lam, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Janice J. Eng, Ph.D

Role: STUDY_DIRECTOR

University of British Columbia

Locations

Human Locomotion Lab, University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26230667 (View on PubMed)

Other Identifiers

H07-01394

Identifier Type: -

Identifier Source: org_study_id