Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PalmRim Experimental | Experimental | Participants will have PalmRim installed on their wheelchair. |
|
| Natural-Fix Experiment | Experimental | Participants will have a Natural-Fit installed on their wheelchair. |
|
| Handrim Control | Placebo Comparator | Participants in this arm had a new standard handrim installed on their wheelchair as a control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural-Fit | Device | Ergonomic handrim for wheelchairs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Status Score | The Functional Status Scale, which measures hand and wrist symptoms. | Baseline, 4 Months |
Not provided
Not provided
Natural-Fit
Inclusion Criteria:
Exclusion Criteria:
PalmRim
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael L Boninger, MD | University of Pittsburgh and VA Pittsburgh Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Engineering Research Laboratories | Pittsburgh | Pennsylvania | 15206 | United States |
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.
Subjects were recruited from November 7, 2008 to April 8, 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | Handrim Control Group | Participants will be given a new standard handrim. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Natural-Fit Experiment | Participants will have a Natural-Fit installed on their wheelchair. Natural-Fit : Ergonomic handrim for wheelchairs |
| BG001 | Control Group | Participants will be given a new standard handrim. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Functional Status Score | The Functional Status Scale, which measures hand and wrist symptoms. | 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. | Posted | Baseline, 4 Months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Natural-Fit Experiment | Participants will have a Natural-Fit installed on their wheelchair. Natural-Fit : Ergonomic handrim for wheelchairs |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael L Boninger | Human Engineering Research Laboratories | 412-822-3700 | boninger@upmc.edu |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PalmRim |
| Device |
Ergonomic handrim for wheelchair |
|
| Handrim Control Group | Device | Participants were given a new standard handrim to test. This intervention group is the control group. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will be given a new standard handrim.
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Control Group | Participants will be given a new standard handrim. | 0 | 1 | 0 | 1 |
Not provided
Not provided
| D014947 | Wounds and Injuries |