Effect of Seat Height and Angle on Wheelchair Foot Propulsion

May 6, 2024 updated by: Ed Giesbrecht, University of Manitoba

The purpose of the project is to explore the effect of differences in seat height and seat angle on bilateral foot propulsion using a manual wheelchair. The objectives of the study are to determine whether differences in seat height and seat angle impact: a) propulsion speed; b) knee range of motion used during propulsion; c) effectiveness of foot propulsion gait; and d) perceived difficulty with foot propulsion.

A repeated measures designs allows comparison between 5 different seat height conditions and 4 different seat angle conditions to determine whether there are significant differences in outcome, and if so, which conditions provide better outcomes. Participants will propel a customized MWC through a standardized course using each seat configuration; the sequence will be randomized to reduce any learning effects.

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.

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.
31

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0T6
        • University of Manitoba

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • student in College of Rehabilitation Sciences enrolled in Master of Occupational Therapy, Master of Physical Therapy, or Bachelor of Respiratory Therapy program at the University of Manitoba.
  • Able-bodied individuals

Exclusion Criteria:

  • Students whose hip width exceeds 21 inches or lower leg length is shorter than 16 inches will be excluded as the test manual wheelchair will not accommodate these dimensions.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: LL & 0
Wheelchair seat height will be positioned at lower leg length and set inclination will be zero
Other: Seat height
Seat height of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Other: Seat inclination
Seat inclination of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Experimental: LL + 1
Wheelchair seat height will be positioned at the participant's leg length plus one inch with an inclination of zero
Other: Seat height
Seat height of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Experimental: LL - 1
Wheelchair seat height will be positioned at the participant's leg length minus one inch with an inclination of zero
Other: Seat height
Seat height of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Experimental: LL - 2
Wheelchair seat height will be positioned at the participant's leg length minus two inches with an inclination of zero
Other: Seat height
Seat height of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Experimental: LL - 3
Wheelchair seat height will be positioned at the participant's leg length minus three inches with an inclination of zero
Other: Seat height
Seat height of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Experimental: 3 degrees Inclination
Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 3 degrees
Other: Seat inclination
Seat inclination of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Experimental: 6 degrees Inclination
Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 6 degrees
Other: Seat inclination
Seat inclination of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
Experimental: 9 degrees Inclination
Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 9 degrees
Other: Seat inclination
Seat inclination of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.

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
Propulsion speed
Time Frame: ~30-60 seconds
Speed will be determined via video recording. Two outcomes will be determined initial 10m and total test course
~30-60 seconds
Knee range of motion
Time Frame: ~30-60 seconds
Xsens sensors and mobile app will be used to determine the positions of the thigh and lower leg and knee joint angle will be obtained from the difference between these positions.
~30-60 seconds
Effectiveness of foot propulsion gait
Time Frame: ~30-60 seconds
Evaluated using the Wheelchair Propulsion Test developed by Askari et al. (2013). Simple, valid and reliable measure of propulsion for either upper or lower extremity propulsion techniques.
~30-60 seconds
Perceived difficulty with foot propulsion
Time Frame: ~30-60 seconds
Participant will provide subjective evaluations of how difficult they found foot propulsion after each trial, using Perceived Difficulty Questionnaire (Heinrichs et al., 2021).
~30-60 seconds

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.
University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
April 20, 2023

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.
October 30, 2023

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.
October 30, 2023

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).
February 7, 2023

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.
September 12, 2023

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.
September 13, 2023

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.
May 8, 2024

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.
May 6, 2024

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.
May 1, 2024

More Information

Terms related to this study

Keywords

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.
  • HS25835 (H2023:027)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared outside of the principle and student investigator's conducting this study.

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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