Back to resultsComparison of User Experience With Wheelsoft Wheels Intalled on a Wheelchair Compared With Normal Wheels.
Primary Purpose
Back Pain, Personal Satisfaction, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Shock absorbing wheelchair
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
Eligibility Criteria
Inclusion Criteria:
- wheelchair bound for at least 4 days
Exclusion Criteria:
- not able to answer verbal questions
- over 95 kg of weight (wheel limit)
Sites / Locations
- haemek MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
softwheels at second round
softwheels at first round
Arm Description
Begining with regular wheelchair for 2 days and then changing for shock absorbing wheelchair for 2 days
starting with Shock absorbing wheelchair for 2 days and then changing for regular wheelchair for 2 days
Outcomes
Primary Outcome Measures
Satisfaction - first round
Overall satisfaction from wheelchair (regarding pain, comfort, tiredness, muscle crumps, feeling of safety) will be measured by questionairre after the first round
Secondary Outcome Measures
Satisfaction - Second round
Overall satisfaction from wheelchair (regarding pain, comfort, tiredness, muscle crumps, feeling of safety) will be measured by questionairre after the second round
Full Information
NCT ID
NCT02925910
First Posted
September 29, 2016
Last Updated
February 27, 2018
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02925910
Brief Title
Comparison of User Experience With Wheelsoft Wheels Intalled on a Wheelchair Compared With Normal Wheels.
Official Title
Assesment of Patient Experience Using a Wheelchair Equipped With Suspension Wheels
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 10, 2018 (Actual)
Study Completion Date
February 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Two groups of randomised rehabilitation patients will try a softwheels wheelchair and a regular one. One group will start with the softwheelsl and then change to the regular, and the other will start with the regular and then change to the softwheel.
Detailed Description
The patients who are received to the rehabilitation ward and are confined to the use of a wheelchair are randomized to two groups. The first are given a wheelchair with wheelsoft wheels and the second group with regular wheels. The wheels of the chair are all covered to look similar to regular wheels (the regular wheels are also covered). All the patients will be taken once a day to a 10 minute trip with the wheelchair. After two days a questionnaire regarding their experience with the chair will be passed. On the third day the groups will change their wheels to the other kind. And again taken to daily trips and a final questionnaire on day four. We will collect additional data from the patients: age, sex, medical record, weight, height, ethnic background, marital status, working status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Personal Satisfaction, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
softwheels at second round
Arm Type
Other
Arm Description
Begining with regular wheelchair for 2 days and then changing for shock absorbing wheelchair for 2 days
Arm Title
softwheels at first round
Arm Type
Other
Arm Description
starting with Shock absorbing wheelchair for 2 days and then changing for regular wheelchair for 2 days
Intervention Type
Device
Intervention Name(s)
Shock absorbing wheelchair
Other Intervention Name(s)
Softwheel wheelchair
Intervention Description
2 randomised groups will try the softwheel wheelchair compare to regular one, but in different order.
Primary Outcome Measure Information:
Title
Satisfaction - first round
Description
Overall satisfaction from wheelchair (regarding pain, comfort, tiredness, muscle crumps, feeling of safety) will be measured by questionairre after the first round
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Satisfaction - Second round
Description
Overall satisfaction from wheelchair (regarding pain, comfort, tiredness, muscle crumps, feeling of safety) will be measured by questionairre after the second round
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
wheelchair bound for at least 4 days
Exclusion Criteria:
not able to answer verbal questions
over 95 kg of weight (wheel limit)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
uriel giwnewer, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
haemek MC
City
Afula
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of User Experience With Wheelsoft Wheels Intalled on a Wheelchair Compared With Normal Wheels.
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