The Effect of Locomotor Training on Children With Incomplete Spinal Cord Injuries
NCT ID: NCT00931983
Last Updated: 2011-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2009-03-31
Brief Summary
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The purpose of this study is to address how well children with incomplete spinal cord injuries of greater than 12 months duration who remain non-functional ambulators improve through body weight assisted treadmill training (BWATT).
Detailed Description
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The BWSTT uses a counterweight harness system to unload the patient's body weight while he or she is on a treadmill. The patient's legs are manually moved by trained therapists through the human gait cycle while maintaining a correct upright posture. Functional and social re-integration outcome assessments are administered before and after each treatment period.
The aim, this year, is to recruit five children who have been living with a spinal cord injury for at least 12 months. The 12-month timeframe was chosen to limit any gait improvement from spontaneous recovery as well as to ensure medical stability.
The study will be conducted over a nine-week period. There are two three-week training sessions separated by a three-week rest period. The BWSTT therapy will be held twice daily for 30 minute sessions. The children and their families return home between the two training periods and are allowed to continue any conventional physiotherapy program they started prior to participating in the study. Outcomes will be re-evaluated during the second three-week training period.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Non-ambulatory or 'exercise only' ambulators with or without assistive devices
* Normal motor and cognitive development up to time of injury
* Medical Stability
Exclusion Criteria
* Contraindication to weight bearing on lower extremities
* Pressure sores where harness would be applied
* Uncontrollable hypotension when upright
* Lower limb contractures impeding range of motion necessary for ambulation
* Prior enrolment in a BWATT program
* Unable to commit to intervention for duration of protocol
4 Years
18 Years
ALL
No
Sponsors
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Rick Hansen Foundation
OTHER
Shriners Hospitals for Children
OTHER
Fondation pour la Recherche sur la Moelle Épinière (Spinal Cord Research Foundation)
UNKNOWN
McGill University
OTHER
Responsible Party
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Shriners Hospitals for Children-Canada
Principal Investigators
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Mohan Radhakrishna, Md, FRCPC
Role: PRINCIPAL_INVESTIGATOR
McGill University, Shriners Hospitals for Children-Canada
Hugues Barbeau, Pt, PhD
Role: STUDY_CHAIR
McGill University
Joanne Ruck-Gibis, Pt, MSc
Role: STUDY_CHAIR
McGill University
Kathleen Montpetit, Ot, MSc
Role: STUDY_CHAIR
McGill University, Shriners Hospitals for Children-Canada
Jean Ouellet, Md, FRCSC
Role: STUDY_CHAIR
McGill University, Shriners Hospitals for Children-Canada
Locations
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Shriners Hospitals for Children-Canada
Montreal, Quebec, Canada
Countries
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References
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Barbeau H, Nadeau S, Garneau C. Physical determinants, emerging concepts, and training approaches in gait of individuals with spinal cord injury. J Neurotrauma. 2006 Mar-Apr;23(3-4):571-85. doi: 10.1089/neu.2006.23.571.
Behrman AL, Nair PM, Bowden MG, Dauser RC, Herget BR, Martin JB, Phadke CP, Reier PJ, Senesac CR, Thompson FJ, Howland DR. Locomotor training restores walking in a nonambulatory child with chronic, severe, incomplete cervical spinal cord injury. Phys Ther. 2008 May;88(5):580-90. doi: 10.2522/ptj.20070315. Epub 2008 Mar 6.
Other Identifiers
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2009-38
Identifier Type: -
Identifier Source: org_study_id