NCT06035484

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2023

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

February 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

February 7, 2023

Last Update Submit

May 6, 2024

Conditions

Keywords

Manual WheelchairBilateral propulsionFoot propulsion

Outcome Measures

Primary Outcomes (4)

  • Propulsion speed

    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

    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

    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

    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

Study Arms (8)

LL & 0

EXPERIMENTAL

Wheelchair seat height will be positioned at lower leg length and set inclination will be zero

Other: Seat heightOther: Seat inclination

LL + 1

EXPERIMENTAL

Wheelchair seat height will be positioned at the participant's leg length plus one inch with an inclination of zero

Other: Seat height

LL - 1

EXPERIMENTAL

Wheelchair seat height will be positioned at the participant's leg length minus one inch with an inclination of zero

Other: Seat height

LL - 2

EXPERIMENTAL

Wheelchair seat height will be positioned at the participant's leg length minus two inches with an inclination of zero

Other: Seat height

LL - 3

EXPERIMENTAL

Wheelchair seat height will be positioned at the participant's leg length minus three inches with an inclination of zero

Other: Seat height

3 degrees Inclination

EXPERIMENTAL

Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 3 degrees

Other: Seat inclination

6 degrees Inclination

EXPERIMENTAL

Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 6 degrees

Other: Seat inclination

9 degrees Inclination

EXPERIMENTAL

Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 9 degrees

Other: Seat inclination

Interventions

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.

LL & 0LL + 1LL - 1LL - 2LL - 3

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.

3 degrees Inclination6 degrees Inclination9 degrees InclinationLL & 0

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (2)

  • Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.

    PMID: 23499781BACKGROUND
  • Heinrichs ND, Kirby RL, Smith C, Russell KFJ, Theriault CJ, Doucette SP. Effect of seat height on manual wheelchair foot propulsion, a repeated-measures crossover study: part 1 - wheeling forward on a smooth level surface. Disabil Rehabil Assist Technol. 2021 Nov;16(8):831-839. doi: 10.1080/17483107.2020.1741036. Epub 2020 Apr 2.

    PMID: 32238086BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Within-subjects repeated measures design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 7, 2023

First Posted

September 13, 2023

Study Start

April 20, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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

Locations