Effect of Travel Direction, Body Position and Technique on the Ease of Getting an Occupied Wheelchair Over a Soft Surface

September 21, 2022 updated by: Lee Kirby, Nova Scotia Health Authority

Effect of Travel Direction, Body Position and Technique on the Ease of a Caregiver Getting an Occupied Wheelchair Over a Soft Surface: a Randomized Crossover Trial

Wheelchair skills training is an important step in the wheelchair provision process. Caregivers play an important role in the lives of wheelchair users but very little is known about wheelchair skills training for caregivers. The goal of the study is to understand the effect of wheelchair travel direction, wheelchair occupant body position and technique used by caregivers on the ease of getting an occupied wheelchair over a soft surface.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Able bodied participants will be used to simulate caregivers and wheelchair occupants. Participants simulating caregivers will be asked to move the occupied wheelchair over a 5 m soft surface. Participants will be randomly assigned a direction to move the wheelchair (forward or backwards), wheelchair occupant body position (upright or leaning forward) and technique in moving the wheelchair (upright with all 4 wheels on ground or in a wheelie position with the wheelchair tipped backwards and balanced on the rear wheels). The ease of getting the occupied wheelchair over the soft surface will be evaluated by the amount of time taken to complete the task, how well the participant completed the task and the ease of performing the task as evaluated by the participant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • Nova Scotia Rehabilitation and Arthritis Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • able to communicate in English,
  • alert, cooperative, and competent to provide informed consent,
  • willing to participate (as evidenced by attending the single data-collection session), and
  • have no physical impairments that would prevent their being able to push and pull a wheelchair over a soft surface

Exclusion Criteria:

  • have unstable medical conditions that might make the handling of a manual wheelchair dangerous, or emotional problems that might make participation unsafe or unpleasant.

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Upright wheelchair forward and occupant upright
Participant will push an upright wheelchair forward over a 5 m soft surface with the wheelchair occupant in the upright body position. The participant will perform the task once.
Other: Wheelchair forward direction
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the forward direction. Participants will push the wheelchair when moving forward.
Other: Upright technique
Participants will move the wheelchair across the 5 m soft surface using the upright technique. The upright technique involves the wheelchair being moved with all 4 wheels on the ground.
Other: Wheelchair occupant upright body position
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
Experimental: Upright wheelchair backward and occupant upright
Participant will pull an upright wheelchair backwards over a 5 m soft surface with the wheelchair occupant in the upright body position. The participant will perform the task once.
Other: Upright technique
Participants will move the wheelchair across the 5 m soft surface using the upright technique. The upright technique involves the wheelchair being moved with all 4 wheels on the ground.
Other: Wheelchair occupant upright body position
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
Other: Wheelchair backward direction
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the backward direction. Participants will pull the wheelchair when moving backwards.
Experimental: Wheelie wheelchair forward and occupant upright
Participant will push a wheelchair using the wheelie technique forward over a 5 m soft surface with the wheelchair occupant in the upright body position.The participant will perform the task once.
Other: Wheelchair forward direction
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the forward direction. Participants will push the wheelchair when moving forward.
Other: Wheelchair occupant upright body position
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
Other: Wheelie technique
Participants will move the wheelchair across the 5 m soft surface using the wheelie technique. The wheelie technique involves the wheelchair being tipped backward and balanced on the rear wheels. Participant wheelchair occupants will always be upright when being moved using the wheelie technique.
Experimental: Wheelie wheelchair backward and occupant upright
Participant will pull a wheelchair using the wheelie technique backwards over a 5 m soft surface with the wheelchair occupant in the upright body position.The participant will perform the task once.
Other: Wheelchair occupant upright body position
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
Other: Wheelchair backward direction
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the backward direction. Participants will pull the wheelchair when moving backwards.
Other: Wheelie technique
Participants will move the wheelchair across the 5 m soft surface using the wheelie technique. The wheelie technique involves the wheelchair being tipped backward and balanced on the rear wheels. Participant wheelchair occupants will always be upright when being moved using the wheelie technique.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time taken to perform task
Time Frame: through study completion , an average of 1 hour
The amount of time in seconds taken to perform the task and move the occupied wheelchair across 5 meters of soft surface (gym mats).
through study completion , an average of 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ability to perform task
Time Frame: through study completion , an average of 1 hour
The ability of the participant to perform the task of moving the occupied wheelchair across the 5 meter soft surface. Participant will be scored using an ordinal scale from 0 to 3 (0 = fail, distance completed < 2.5 m and /or time taken more than 20 seconds, 1=partial pass with distance completed between 2.5 m and 4.9 m and time less than or equal to 20 seconds, 2 = pass with completion of the 5 m distance and time taken between 11 and 20 seconds, and advanced pass = 3 with completion of the 5 m distance and time taken being less than or equal to 10 seconds).
through study completion , an average of 1 hour
Ease of performing the task
Time Frame: through study completion , an average of 1 hour
Participant self-reported ease of performing the task of moving the occupied wheelchair over a 5 meter soft surface. A five-point Likert scale with 4 = "very easy", 3 = "somewhat easy", 2 = "neither easy nor difficult", 1 = "somewhat difficult" and 0 = "very difficult".
through study completion , an average of 1 hour

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dalhousie University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WSP-2021PP
  • 1027105 (Other Identifier: Nova Scotia Health REB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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