The Effect of Locomotor Training on Children With Incomplete Spinal Cord Injuries

December 13, 2011 updated by: McGill University

--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).

Study Overview

Status

Withdrawn

Conditions

Detailed Description

In the past, this type of treatment has been offered to adults living with a spinal cord injury, but only recently has it been extended, in the US, to children so affected. Numerous trials indicate that BWSTT does improve human gait patterns in adults. As children have more neuroplasticity than adults, we believe they should respond well to BWSTT.

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A6
        • Shriners Hospitals for Children-Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
10 meter walk
Time Frame: Baseline (time 0)
Baseline (time 0)
10 meter walk
Time Frame: 9 weeks
9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pediatric Life Habits Questionnaire
Time Frame: baseline (time 0)
baseline (time 0)
Pediatric Life Habits Questionnaire
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

Shriners Hospitals for Children
Rick Hansen Foundation
Fondation pour la Recherche sur la Moelle Épinière (Spinal Cord Research Foundation)

Investigators

  • Principal Investigator: Mohan Radhakrishna, Md, FRCPC, McGill University, Shriners Hospitals for Children-Canada
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

December 14, 2011

Last Update Submitted That Met QC Criteria

December 13, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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