Effects of an Early Wheelchair Reconditionong Program on... | NCT01105260

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

NCT01105260

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Last Update Posted

Jul 28, 2015Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A00866-51	Other Identifier	AFSSAPS

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty to include patients

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Jun 2015Actual

First Submitted Date

Mar 23, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control		group with classical rehabilitation program
training		group with an 8 weeks interval training program on wheelchair independence

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients with acute spinal cord injury (SCI) from trauma, medical or surgical pathology at levels between C7 and L1

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Calmels, MD	CHU de Saint-Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon		Besançon			France
Centre de Rééducation de la Tour de Gassie

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided