NCT02925910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

September 29, 2016

Last Update Submit

February 27, 2018

Conditions

Back PainPersonal SatisfactionFatigue

Outcome Measures

Primary Outcomes (1)

  • 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

    2 days

Secondary Outcomes (1)

  • Satisfaction - Second round

    2 days

Study Arms (2)

softwheels at second round

OTHER

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

Device: Shock absorbing wheelchair

softwheels at first round

OTHER

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

Device: Shock absorbing wheelchair

Interventions

Shock absorbing wheelchairDEVICE

2 randomised groups will try the softwheel wheelchair compare to regular one, but in different order.

Also known as: Softwheel wheelchair
softwheels at first roundsoftwheels at second round

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • wheelchair bound for at least 4 days

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

haemek MC

Afula, Israel

Location

MeSH Terms

Conditions

Back PainPersonal SatisfactionFatigue

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • uriel giwnewer, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 6, 2016

Study Start

February 1, 2017

Primary Completion

February 10, 2018

Study Completion

February 10, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)