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Completed

NCT Number: NCT00610974

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

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Locomotion Lab, University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
  • 19 to 65 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 11th thoracic level (lower motoneuron injury)
  • weight greater than 300 lbs or height greater than 6'1"
  • 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

Treatment and study plan

Body-weight supported treadmill training

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.

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Average activity level per day measured before, after, 1-month after, and 6-months after training

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 8, 2008
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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