WheelchairsNCT03330912

The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs

A study testing Neutral seat height, Very low seat height and Low seat height in people with Wheelchairs and Hemiplegia, run by Lee Kirby at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Wheelchairs, Hemiplegia
What is being tested?: Neutral seat height, Very low seat height and Low seat height
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteCanada
Study dates: 1 May 2018to 1 Sep 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

willing to participate
is right-hand dominant (to simplify wheelchair and laboratory set-up)
has a subjective unshod height of ≤ 183 cm (6'0")
is able to be comfortably seated in the manual wheelchair used for the study
is 18 years of age or older, is alert and cooperative
is competent to provide informed consent
is able to communicate in English
does not have an unstable medical condition

Who cannot join

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

This study evaluates the effect of seat height on hemiplegic-pattern wheelchair propulsion. Each subject will act as their own control and measures will be obtained in a one sixty minute session. Five seat heights relative to the subject's leg length will be measured in a random order to see the effect on forward and backwards wheelchair propulsion.

Read the detailed description

Many people who have suffered a stroke require a wheelchair for mobility. Hemiplegia is a common result of stroke.Many people with hemiplegia propel themselves using their sound-side arms and legs ("hemiplegic-pattern propulsion") in manual wheelchairs.Often people using this pattern are prescribed wheelchairs with a reduced seat height to facilitate foot propulsion. Despite the seeming obviousness of the need to lower the seat height for people who use foot propulsion,there is little available evidence to help establish optimal wheelchair seat height. The study objective is to test the hypothesis that there is an optimum wheelchair seat height (expressed as a percentage of the lower leg length) for hemiplegic-pattern wheelchair propulsion. The investigators expect that the optimum seat height will be lower than that usually used for wheelchairs that are hand-propelled.

A single-subject design with able-bodied participants will be used to investigate 5 randomized seat heights. The 5 seat heights will be set relative to the subjects leg length at a single 60 minute data collection session All measures will be obtained during one session. The optimal seat height will be chosen based on wheelchair propulsion speed, push frequency and effectiveness over 10m going forward on smooth surface, and 5m going backwards over a soft surface.

Conditions: Wheelchairs, Hemiplegia
Being tested: Neutral seat height, Very low seat height, Low seat height, Very high seat height, High seat height
Medical subject headings: Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neutral seat heightDevice
Seat height set relative to participant's leg length with neutral set at the measured lower leg length
Very low seat heightDevice
Seat height set relative to participant's leg length, 2" below the measured lower leg length
Low seat heightDevice
Seat height set relative to participant's leg length, 1" below the measured lower leg length
Very high seat heightDevice
Seat height set relative to participant's leg length, 2" above the measured lower leg length
High seat heightDevice
Seat height set relative to participant's leg length, 1" above the measured lower leg length

Study groups in NCT03330912
Study group	Role	What they receive
Seat Height Intervention	Experimental	Randomly assigned 5 wheelchair seat heights ranging from very low (2" below) to very high (2" above) the lower leg length of the participant. Receives: Device: Neutral seat height; Device: Very low seat height; Device: Low seat height; Device: Very high seat height; Device: High seat height

What is being measured

The primary outcome is the main question the study is designed to answer.

speed (m/s)
wheelchair propulsion speed over 10 m forward and 5 m backward
Measured: same day measure obtained immediately after seat adjustment, approximately 10 minutes
push frequency (cycles per second)
number of foot cycles completed over the 10 m forward and 5 m backward
Measured: same day measure obtained immediately after seat adjustment, approximately 10 minutes
Propulsion effectiveness
distance travelled per foot propulsion cycle
Measured: same day measure obtained immediately after seat adjustment, approximately 10 minutes

Secondary outcomes (2)

forward propulsion wheelchair skills test score
fail, pass with difficulty or pass for wheeling forward 10 m
Measured: same day measure obtained immediately after seat adjustment, approximately 10 minutes
propulsion difficulty questionnaire
Investigator developed questionnaire asking how difficult it was to perform the propulsion test. The participant will self-report his/her level of difficulty for this skill using a five-point Likert scale (1 =very easy, 2=somewhat easy, 3=neither easy nor difficult, 4= somewhat difficult and 5=very difficult). A single number will be reported.
Measured: same day measure obtained immediately after seat adjustment, approximately 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20181 Sep 2019

First posted6 Nov 2017
Study start1 May 2018
Primary completion1 Sep 2019
Study completion1 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for WheelchairsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Model description: Single subject - participants will be compared to themselves. STROBE guidelines will be followed.
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03330912
Sponsor's protocol ID: 1022716
Status last verified: Sep 2020
First submitted: 30 Oct 2017
Last updated: 11 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32238086
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 2 - wheeling backward on a soft surface. Disabil Rehabil Assist Technol. 2022 Apr;17(3):325-330. doi: 10.1080/17483107.2020.1782490. Epub 2020 Jun 27.
PubMed 32594783

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
Manual Wheelchair Use, Spinal Cord Injury
Not yet recruiting
Efficacy of Seated Physical Activity INtervention(SPIN) for Wheelchair Users With Multiple Sclerosis
Multiple Sclerosis
Not yet recruiting
Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology.
Paraplegia, Spinal Cord Injury
Not yet recruiting
User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems
Mobility Impairment

All Wheelchairs trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs
ClinicalTrials.gov ID: NCT03330912
Acronym / sponsor ID: 1022716
Conditions: Wheelchairs, Hemiplegia
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Lee KirbyUniversity, hospital or other
Study start: 1 May 2018 (actual)
Primary completion: 1 Sep 2019 (actual)
Study completion: 1 Sep 2019 (actual)
First posted: 6 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single subject - participants will be compared to themselves. STROBE guidelines will be followed.

Arm	Type	Receives
Seat Height Intervention	Experimental	Device: Neutral seat height, Device: Very low seat height, Device: Low seat height, Device: Very high seat height, Device: High seat heightRandomly assigned 5 wheelchair seat heights ranging from very low (2" below) to very high (2" above) the lower leg length of the participant.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

willing to participate
is right-hand dominant (to simplify wheelchair and laboratory set-up)
has a subjective unshod height of ≤ 183 cm (6'0")
is able to be comfortably seated in the manual wheelchair used for the study
is 18 years of age or older, is alert and cooperative

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neutral seat heightSeat height set relative to participant's leg length with neutral set at the measured lower leg length	Device	Seat Height Intervention
Very low seat heightSeat height set relative to participant's leg length, 2" below the measured lower leg length	Device	Seat Height Intervention
Low seat heightSeat height set relative to participant's leg length, 1" below the measured lower leg length	Device	Seat Height Intervention
Very high seat heightSeat height set relative to participant's leg length, 2" above the measured lower leg length	Device	Seat Height Intervention
High seat heightSeat height set relative to participant's leg length, 1" above the measured lower leg length	Device	Seat Height Intervention

Primary outcome

speed (m/s)
Time frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
wheelchair propulsion speed over 10 m forward and 5 m backward
push frequency (cycles per second)
Time frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
number of foot cycles completed over the 10 m forward and 5 m backward
Propulsion effectiveness
Time frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
distance travelled per foot propulsion cycle

2 secondary outcomes

forward propulsion wheelchair skills test score
Time frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
propulsion difficulty questionnaire
Time frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
Background: PubMed 32238086Heinrichs 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.
Background: PubMed 32594783Heinrichs 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 2 - wheeling backward on a soft surface. Disabil Rehabil Assist Technol. 2022 Apr;17(3):325-330. doi: 10.1080/17483107.2020.1782490. Epub 2020 Jun 27.
Individual participant dataSharing planned: No

Related trials for Wheelchairs

Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
Manual Wheelchair Use, Spinal Cord Injury
Not yet recruiting
Efficacy of Seated Physical Activity INtervention(SPIN) for Wheelchair Users With Multiple Sclerosis
Multiple Sclerosis
Not yet recruiting
Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology.
Paraplegia, Spinal Cord Injury
Not yet recruiting
User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems
Mobility Impairment

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lee Kirby, MD principal investigator

Nova Scotia Health Authority, Dalhousie University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neutral seat height, Very low seat height and Low seat height in people with Wheelchairs and Hemiplegia, run by Lee Kirby at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

speed (m/s) (time frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03330912, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.