Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals

Study Overview
=================
Brief Summary
-----------------
Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of medical complications; or to improve the mobility. The restrictive autonomy is due to different factors: firstly wheelchair users reduce their movement because they need technical or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs. Without specific practice, the upper limbs mechanical and physiological properties do not permit exercises that are long and intense. Then, the purpose of this research is to evaluate the effects of an 8 weeks interval training program on wheelchair independance during inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to a control group (classical rehabilitation program in a physical medicine and rehabilitation department).

Official Title
-----------------
Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals

Conditions
-----------------
Spinal Cord Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute spinal cord injury (SCI) from trauma , medical or surgical pathology at levels between C7 and L1. Categories A or B as defined by the American Spinal Injury Association (ASIA) Impairment Scale Male or female 18 to 60 years old. No ability to walk independently with or without an assistive device 3 to 6 months post-SCI in early phase of rehabilitation in a physical medicine and rehabilitation unit. Subject affiliated to a social security regime and registered at the healthcare department Written informed consent obtained from each subject Exclusion Criteria: Symptomatic syringomyelia that may complicate the evaluation procedures Disabled pathology before the SCI Cardiopulmonary disease, degenerative disorders, upper limb disorders, bones inury or other significant medical complications that would prohibit or alter compliance with a wheelchair training protocol. Psychological incapacity to follow a training protocol during 8 weeks. Surgery or intrathecal injection planned. Reject to give written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>group with classical rehabilitation program | |
| training<br>group with an 8 weeks interval training program on wheelchair independence | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wheelchair independence and mobility | adapted 6-minutes walk test (maximal distance ran in 6 minutes with patient's personal wheelchair) crossing a 5% slope functional independence measure (FIM) quality of life | inclusion and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular parameters | Maximal exercise test (maximal oxygen uptake, maximal tolerated power (MTP), ventilatory threshold (VS), maximal heart rate, blood pressure, blood lactate) Three exercise tests to exhaustion (work rate fixed at 90, 100 and 110 % MTP, to determine the critical power (power which can be sustained without fatigue) | inclusion and 6 month | 
| Biomechanic parameters during manuel wheelchair propulsion | Push phases push frequency total cycle time | inclusion and 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early reconditioning program, spinal cord injury, early rehabilitation, wheelchair