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

This study has been terminated.
(Difficulty to include patients)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01105260
First received: March 23, 2010
Last updated: July 27, 2015
Last verified: July 2015
  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


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: June 2015
Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105260

Locations
France
CHU Besançon
Besançon, France
Centre de Rééducation de la Tour de Gassie
Bruges, France
Groupe Hospitalier Raymond Poincaré - APHP
Garches, France
Service MPR des Kermes - Hôpital René Sabran
Giens, France
Centre mutualiste neurologique Propara
Montpellier, France
CHU Nantes
Nantes, France
Centre mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Ploemeur, France
Centre de Réadaptation fonctionnelle - UGECAM
Strasbourg, France
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: July 27, 2015
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
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 03, 2015