Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals
This study is currently recruiting participants.
Verified November 2012 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01105260
First received: March 23, 2010
Last updated: November 22, 2012
Last verified: November 2012
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Purpose
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).
| Condition |
|---|
|
Spinal Cord Injuries |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:
Primary Outcome Measures:
- wheelchair independence and mobility [ Time Frame: inclusion and 6 month ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Cardiovascular parameters [ Time Frame: inclusion and 6 month ] [ Designated as safety issue: No ]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)
- Biomechanic parameters during manuel wheelchair propulsion [ Time Frame: inclusion and 6 month ] [ Designated as safety issue: No ]Push phases push frequency total cycle time
| Estimated Enrollment: | 82 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
control
group with classical rehabilitation program
|
|
training
group with an 8 weeks interval training program on wheelchair independence
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105260
Contacts
| Contact: Paul Calmels, MD | +33(0)477127537 | paul.calmels@chu-st-etienne.fr |
Locations
| France | |
| CHU Besançon | Recruiting |
| Besançon, France | |
| Contact: Bernard Parratte, MD | |
| Principal Investigator: Bernard Parratte, MD | |
| Centre de Rééducation de la Tour de Gassie | Recruiting |
| Bruges, France | |
| Contact: David GOOSSENS | |
| Principal Investigator: David GOOSSENS, MD | |
| Groupe Hospitalier Raymond Poincaré - APHP | Recruiting |
| Garches, France | |
| Contact: Pierre Denys, MD | |
| Principal Investigator: Pierre DENYS, MD | |
| Service MPR des Kermes - Hôpital René Sabran | Recruiting |
| Giens, France | |
| Contact: Hubert Tournebize | |
| Principal Investigator: Hubert TOURNEBIZE, MD | |
| Centre mutualiste neurologique Propara | Recruiting |
| Montpellier, France | |
| Contact: Charles Fattal | |
| Principal Investigator: Charles Fattal, MD | |
| CHU Nantes | Recruiting |
| Nantes, France | |
| Contact: Brigitte Perrouin-Verbe, MD | |
| Principal Investigator: Brigitte Perrouin Verbe | |
| Centre mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape | Recruiting |
| Ploemeur, France | |
| Contact: Pierre Pedelucq, MD | |
| Principal Investigator: Pierre Pedelucq | |
| Centre de Réadaptation fonctionnelle - UGECAM | Recruiting |
| Strasbourg, France | |
| Contact: Dominique Gault | |
| Principal Investigator: Dominique GAULT, MD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
| Principal Investigator: | Paul Calmels, MD | CHU de Saint-Etienne |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT01105260 History of Changes |
| Other Study ID Numbers: | 0901040, 2009-A00866-51 |
| Study First Received: | March 23, 2010 |
| Last Updated: | November 22, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
early reconditioning program spinal cord injury early rehabilitation wheelchair |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013