Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00610974

Purpose

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.

Condition	Intervention
Motor-Incomplete Spinal Cord Injury	Behavioral: Body-weight supported treadmill training

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average activity level per day measured before, after, 1-month after, and 6-months after training [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	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.
2: Experimental 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.	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.

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

Ages Eligible for Study:	19 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
19 to 50 years of age
use of standing or walking as part of typical activities of daily living
controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study

Exclusion Criteria:

lesion below 12th thoracic level (lower motoneuron injury)
body mass index > 30
femur length <35 cm or >47 cm and body weight >150 kg
cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
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
existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30)
participation in rehabilitation therapy or other research study with exercise or mobility outcomes
unable to read or understand English

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610974

Contacts

Contact: Kathryn Luttmann

604-827-4563

walkubc@gmail.com

Locations

Canada, British Columbia
Human Locomotion Lab, University of British Columbia	Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Kathryn Luttmann 604-827-4563 walkubc@gmail.com

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Tania Lam, Ph.D	University of British Columbia
Study Director:	Janice J. Eng, Ph.D	University of British Columbia

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	University of British Columbia ( Tania Lam )
Study ID Numbers:	H07-01394
Study First Received:	January 28, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00610974
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

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

Study placed in the following topic categories:

Body Weight
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009