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

Withdrawn

• Conditions: Spinal Cord Injuries

• Registration Number: NCT00931983
• Lead Sponsor: McGill University

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).

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Status Verified: 2011-07
• Last Update Submitted: 2011-12-13
• Last Update Posted: 2011-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
10 meter walk	9 weeks

Secondary Outcome Measures

Name	Time	Method
Pediatric Life Habits Questionnaire	9 weeks

Trial Locations

Locations (1)

Shriners Hospitals for Children-Canada; 🇨🇦 Montreal, Quebec, Canada