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

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ClinicalTrials.gov Identifier: NCT00931983
Recruitment Status : Withdrawn
First Posted : July 2, 2009
Last Update Posted : December 14, 2011
Information provided by:

Study Description
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).

Condition or disease
Spinal Cord Injuries

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 Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Locomotor Training on Children With Incomplete Spinal Cord Injuries
Study Start Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 10 meter walk [ Time Frame: Baseline (time 0) ]
  2. 10 meter walk [ Time Frame: 9 weeks ]

Secondary Outcome Measures :
  1. Pediatric Life Habits Questionnaire [ Time Frame: baseline (time 0) ]
  2. Pediatric Life Habits Questionnaire [ Time Frame: 9 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931983

Canada, Quebec
Shriners Hospitals for Children-Canada
Montreal, Quebec, Canada, H3G 1A6
Sponsors and Collaborators
McGill University
Rick Hansen Foundation
Shriners Hospitals for Children
Fondation pour la Recherche sur la Moelle Épinière (Spinal Cord Research Foundation)
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
More Information

Responsible Party: Mohan Radhakrishna, Md, FRCSC, Shriners Hospitals for Children-Canada
ClinicalTrials.gov Identifier: NCT00931983     History of Changes
Other Study ID Numbers: 2009-38
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: July 2011

Keywords provided by McGill University:
Incomplete spinal cord injuries

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System