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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01105260
• Other study ID #: 0901040
• Secondary ID: 2009-A00866-51
• Status: Terminated
• Phase: N/A
• First received: March 23, 2010
• Last updated: July 27, 2015
• Start date: March 2010
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Biomechanic parameters during manuel wheelchair propulsion	Push phases push frequency total cycle time	inclusion and 6 month	No