Physical Performance Measures for Manual Wheelchair Users | NCT00011544

Studies
Physical Performance Measures for Manual Wheelchair Users

NCT00011544

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Jan 21, 2009Estimated

Enrollment

120

Phase

Phase 2

Conditions

Spinal Cord Injury

Interventions

Performance Measure

Countries

United States

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

Status Module

Record Verification Date

Jan 2001

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998

Primary Completion Date

Not provided

Completion Date

Dec 2000Actual

First Submitted Date

Feb 22, 2001

First Submission Date that Met QC Criteria

Feb 23, 2001

First Posted Date

Feb 26, 2001Estimated

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

Jan 20, 2009

Last Update Posted Date

Jan 21, 2009Estimated

Description Module

Brief Summary

The project is intended to modify the Functional Independence Measure (FIM) for manual wheelchair users. It will determine if the new measure is a better measure of community independence for manual wheelchair users than the FIM. During the Phase 1 of the study it will then use this new measure to determine whether a home exercise program increases functional independence in wheelchair users. In Phases II and III of the study 120 manual wheelchair users will participate to test and validate the new measure and to test the effectiveness of therapeutic exercise. Subjects will range in age from 20 to 79 yrs. and have a variety of disabilities.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Performance Measure	Procedure

Eligibility Module

Eligibility Criteria

Wheelchair users

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Fryer, Ph.D., Asst. Director	Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Nancy Rocheleau, Program Analyst	Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VAMC, Baltimore		Baltimore	Maryland		United States

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