Clinical trial NCT00931983: The Effect of Locomotor Training on Children With Incomplete Spinal Cord Injuries
Official title: The Effect of Locomotor Training on Children With Incomplete Spinal Cord Injuries
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spinal Cord Injuries
Keywords: Incomplete spinal cord injuries
Walking
Treadmill
Training
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Rick Hansen Foundation
name: Shriners Hospitals for Children
name: Fondation pour la Recherche sur la Moelle Épinière (Spinal Cord Research Foundation)
First posted: 2009-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

Eligibility criteria: 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

Primary outcomes:
measure: 10 meter walk
timeFrame: Baseline (time 0)
measure: 10 meter walk
timeFrame: 9 weeks
Secondary outcomes:
measure: Pediatric Life Habits Questionnaire
timeFrame: baseline (time 0)
measure: Pediatric Life Habits Questionnaire
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Shriners Hospitals for Children-Canada
state: Quebec
Study officials:
affiliation: McGill University, Shriners Hospitals for Children-Canada
name: Mohan Radhakrishna, Md, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Hugues Barbeau, Pt, PhD
role: STUDY_CHAIR
affiliation: McGill University
name: Joanne Ruck-Gibis, Pt, MSc
role: STUDY_CHAIR
affiliation: McGill University, Shriners Hospitals for Children-Canada
name: Kathleen Montpetit, Ot, MSc
role: STUDY_CHAIR
affiliation: McGill University, Shriners Hospitals for Children-Canada
name: Jean Ouellet, Md, FRCSC
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.