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

NCT ID: NCT01105260

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

group with classical rehabilitation program

No interventions assigned to this group

training

group with an 8 weeks interval training program on wheelchair independence

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul Calmels, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Besançon

Besançon, , France

Site Status

Centre de Rééducation de la Tour de Gassie

Bruges, , France

Site Status

Groupe Hospitalier Raymond Poincaré - APHP

Garches, , France

Site Status

Service MPR des Kermes - Hôpital René Sabran

Giens, , France

Site Status

Centre mutualiste neurologique Propara

Montpellier, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

Centre mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Ploemeur, , France

Site Status

Centre de Réadaptation fonctionnelle - UGECAM

Strasbourg, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-A00866-51

Identifier Type: OTHER

Identifier Source: secondary_id

0901040

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Wheelchair Indoors Curling With SCI patients_RCT
NCT02550834 COMPLETED PHASE1/PHASE2
Arm and Leg Cycling for Accelerated Recovery From SCI
NCT05619146 ACTIVE_NOT_RECRUITING NA