NCT00931983

Brief Summary

--Participation open to all Canadian residents-- 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

December 14, 2011

Status Verified

July 1, 2011

First QC Date

July 1, 2009

Last Update Submit

December 13, 2011

Conditions

Keywords

Incomplete spinal cord injuriesWalkingTreadmillTraining

Outcome Measures

Primary Outcomes (2)

  • 10 meter walk

    Baseline (time 0)

  • 10 meter walk

    9 weeks

Secondary Outcomes (2)

  • Pediatric Life Habits Questionnaire

    baseline (time 0)

  • Pediatric Life Habits Questionnaire

    9 weeks

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Children between the ages of 4-18 with incomplete ASIA C or D spinal cord injuries at least 12 months before study enrolment
  • Non-ambulatory or 'exercise only' ambulators with or without assistive devices
  • Normal motor and cognitive development up to time of injury
  • Medical Stability

You may not qualify if:

  • Other neuromuscular disease
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children-Canada

Montreal, Quebec, H3G 1A6, Canada

Location

Related Publications (2)

  • 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.

    PMID: 16629638BACKGROUND
  • 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.

    PMID: 18326054BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Mohan Radhakrishna, Md, FRCPC

    McGill University, Shriners Hospitals for Children-Canada

    PRINCIPAL INVESTIGATOR
  • Hugues Barbeau, Pt, PhD

    McGill University

    STUDY CHAIR
  • Joanne Ruck-Gibis, Pt, MSc

    McGill University

    STUDY CHAIR
  • Kathleen Montpetit, Ot, MSc

    McGill University, Shriners Hospitals for Children-Canada

    STUDY CHAIR
  • Jean Ouellet, Md, FRCSC

    McGill University, Shriners Hospitals for Children-Canada

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 2, 2009

Study Start

March 1, 2009

Last Updated

December 14, 2011

Record last verified: 2011-07

Locations