NCT00281463

Brief Summary

The purpose of this three phase study is to evaluate a Pushrim Activated Power Assist Wheelchair (PAPAW). Phase I will examine whether the steady-state, metabolic energy efficiency for propelling a manual wheelchair with and without the device will be significantly different. In Phase II, wheelchair users will evaluate the PAPAW over activities of daily living course to determine its usability and acceptability and to identify areas for future development. Finally, in phase III, comparison of activities of daily living in the community will be made between the subjects when using their personal wheelchair and a PAPAW.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2001

Longer than P75 for not_applicable

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

November 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

5.3 years

First QC Date

January 23, 2006

Results QC Date

November 6, 2014

Last Update Submit

November 6, 2014

Conditions

Keywords

wheelchairspinal cord injuryrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Oxygen Consumption

    in-lab visit when propelling on a computer controlled wheelchair dynamometer

Study Arms (1)

Pushrim Activated Power Assist Wheelchair

EXPERIMENTAL

Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.

Device: Pushrim Activated Power Assist

Interventions

The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation).

Pushrim Activated Power Assist Wheelchair

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and 65 years of age
  • Full time wheelchair user
  • Diagnosis of Tetraplegia

You may not qualify if:

  • Pressure sores
  • Shoulder pain that would prevent them from propelling a manual wheelchair
  • History of cardiopulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Rory Cooper, PhD
Organization
Human Engineering Research Laboratories

Study Officials

  • Rory A Cooper, PhD

    Human Engineering Research Laboratories

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director; Pittsburgh VA Rehabilitation Research & Development Center

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 24, 2006

Study Start

November 1, 2001

Primary Completion

March 1, 2007

Study Completion

January 1, 2008

Last Updated

November 18, 2014

Results First Posted

November 18, 2014

Record last verified: 2014-11

Locations