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

February 27, 2018 updated by: HaEmek Medical Center, Israel

Assesment of Patient Experience Using a Wheelchair Equipped With Suspension Wheels

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • HaEmek MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • wheelchair bound for at least 4 days

Exclusion Criteria:

  • not able to answer verbal questions
  • over 95 kg of weight (wheel limit)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction - first round
Time Frame: 2 days
Overall satisfaction from wheelchair (regarding pain, comfort, tiredness, muscle crumps, feeling of safety) will be measured by questionairre after the first round
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction - Second round
Time Frame: 2 days
Overall satisfaction from wheelchair (regarding pain, comfort, tiredness, muscle crumps, feeling of safety) will be measured by questionairre after the second round
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: uriel giwnewer, MD, HaEmek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

February 10, 2018

Study Completion (Actual)

February 10, 2018

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115-16emc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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