Spinal Cord Injury
Conditions
Keywords
Wheelchair, Handrims, Rehabilitation, Upper extremity
Brief summary
The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim 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. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.
Detailed description
This research will have three parts. The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand. For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair. In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.
Interventions
DEVICENatural-Fit
Ergonomic handrim for wheelchairs
DEVICEPalmRim
Ergonomic handrim for wheelchair
DEVICEHandrim Control Group
Participants were given a new standard handrim to test. This intervention group is the control group.
Sponsors
University of Pittsburgh
VA Pittsburgh Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Natural-Fit Inclusion Criteria: * Use of a manual wheelchair as a primary means of mobility (over 40 hours per week) * Use a standard handrim * Between the ages of 18 and 55 * Has normal hand function
Exclusion criteria
* Pressure Sores PalmRim Inclusion Criteria: * Use of a manual wheelchair as a primary means of mobility (over 40 hours per week) * Use a vinyl-coated handrim * Between ages 18 and 55 * Has impaired hand function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Status Score | Baseline, 4 Months | The Functional Status Scale, which measures hand and wrist symptoms. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from November 7, 2008 to April 8, 2009.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Natural-Fit Experiment Participants will have a Natural-Fit installed on their wheelchair.
Natural-Fit : Ergonomic handrim for wheelchairs | 3 |
| Control Group Participants will be given a new standard handrim. | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Control Group | Natural-Fit Experiment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 39 years STANDARD_DEVIATION 0 | 48 years STANDARD_DEVIATION 2.11 | 46 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Change in Functional Status Score
The Functional Status Scale, which measures hand and wrist symptoms.
Time frame: Baseline, 4 Months
Population: 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.