Clinical trial NCT01105260: Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals
Official title: Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal Cord Injuries
Keywords: early reconditioning program
spinal cord injury
early rehabilitation
wheelchair
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute spinal cord injury (SCI) from trauma, medical or surgical pathology at levels between C7 and L1

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).


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.

Primary outcomes:
measure: wheelchair independence and mobility
timeFrame: inclusion and 6 month
Secondary outcomes:
measure: Cardiovascular parameters
timeFrame: inclusion and 6 month
measure: Biomechanic parameters during manuel wheelchair propulsion
timeFrame: inclusion and 6 month
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Bruges
country: France
facility: Centre de Rééducation de la Tour de Gassie
city: Garches
country: France
facility: Groupe Hospitalier Raymond Poincaré - APHP
city: Giens
country: France
facility: Service MPR des Kermes - Hôpital René Sabran
city: Montpellier
country: France
facility: Centre mutualiste neurologique Propara
city: Nantes
country: France
facility: CHU Nantes
city: Ploemeur
country: France
facility: Centre mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
city: Strasbourg
country: France
facility: Centre de Réadaptation fonctionnelle - UGECAM
Study officials:
affiliation: CHU de Saint-Etienne
name: Paul Calmels, MD
role: PRINCIPAL_INVESTIGATOR
References: