Trial Outcomes & Findings for Development of an Ergonomic Wheelchair Pushrim (NCT NCT00392860)
NCT ID: NCT00392860
Last Updated: 2014-02-21
Results Overview
The Functional Status Scale, which measures hand and wrist symptoms.
COMPLETED
PHASE2
4 participants
Baseline, 4 Months
2014-02-21
Participant Flow
Subjects were recruited from November 7, 2008 to April 8, 2009.
The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.
Participant milestones
| Measure |
Natural-Fit Experiment
Participants will have a Natural-Fit handrim installed on their wheelchair. The Natural-Fit device was designed to directly address the shortcomings of standard handrims and to improve the standard round-tube handrims which were designed over 50 years ago.
Participants used the Natural-Fit Handrim for a four month trial period, before returning for follow up evaluations.
Natural-Fit : Ergonomic handrim for wheelchairs
|
PalmRim Experiment
Participants will have a PalmRim handrim installed on their wheelchair. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.
Participants were to use the PalmRim handrim for a four month trial period, before returning for follow up evaluations.
|
Handrim Control Group
Participants will be given a new standard handrim.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
1
|
|
Overall Study
COMPLETED
|
3
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of an Ergonomic Wheelchair Pushrim
Baseline characteristics by cohort
| Measure |
Natural-Fit Experiment
n=3 Participants
Participants will have a Natural-Fit installed on their wheelchair.
Natural-Fit : Ergonomic handrim for wheelchairs
|
Control Group
n=1 Participants
Participants will be given a new standard handrim.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
39 years
STANDARD_DEVIATION 0 • n=7 Participants
|
46 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 MonthsPopulation: Zero participants were analyzed because only 4 participants were enrolled in this trial. Analyzing the results would not result in any meaningful information. The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.
The Functional Status Scale, which measures hand and wrist symptoms.
Outcome measures
Outcome data not reported
Adverse Events
Natural-Fit Experiment
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael L Boninger
Human Engineering Research Laboratories
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place