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Comparison of User Experience With Wheelsoft Wheels Intalled on a Wheelchair Compared With Normal Wheels.

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Completed
CT.gov ID
NCT02925910
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
12.3
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Shock absorbing wheelchair
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Assesment of Patient Experience Using a Wheelchair Equipped With Suspension Wheels
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Feb 10, 2018
Actual Study Completion Date :
Feb 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: softwheels at second round

Begining with regular wheelchair for 2 days and then changing for shock absorbing wheelchair for 2 days

Device: Shock absorbing wheelchair
2 randomised groups will try the softwheel wheelchair compare to regular one, but in different order.
Other Names:
  • Softwheel wheelchair

    		•
    Other: softwheels at first round

    starting with Shock absorbing wheelchair for 2 days and then changing for regular wheelchair for 2 days

    Device: Shock absorbing wheelchair
    2 randomised groups will try the softwheel wheelchair compare to regular one, but in different order.
    Other Names:
  • Softwheel wheelchair

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Satisfaction - first round [2 days]

      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

    1. Satisfaction - Second round [2 days]

      Overall satisfaction from wheelchair (regarding pain, comfort, tiredness, muscle crumps, feeling of safety) will be measured by questionairre after the second round

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • wheelchair bound for at least 4 days
    Exclusion Criteria:

    • not able to answer verbal questions

    • over 95 kg of weight (wheel limit)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 haemek MC Afula Israel

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    • Principal Investigator: uriel giwnewer, MD, haemek medical center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HaEmek Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT02925910
    Other Study ID Numbers:
    • 115-16emc
    First Posted:
    Oct 6, 2016
    Last Update Posted:
    Feb 28, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Back Pain
    Fatigue

    Study Results

    No Results Posted as of Feb 28, 2018