NCT00011544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1998

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2001

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2001

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2001

First QC Date

February 22, 2001

Last Update Submit

January 20, 2009

Conditions

Spinal Cord Injury

Keywords

wheelchair, biomechanics, aging, functional outcome, disability

Interventions

Performance MeasurePROCEDURE

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Wheelchair users

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VAMC, Baltimore

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

February 22, 2001

First Posted

February 26, 2001

Study Start

January 1, 1998

Study Completion

December 1, 2000

Last Updated

January 21, 2009

Record last verified: 2001-01

Locations

US(1)