NCT03330912

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

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

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

October 30, 2017

Last Update Submit

September 9, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • speed (m/s)

    wheelchair propulsion speed over 10 m forward and 5 m backward

    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

    same day measure obtained immediately after seat adjustment, approximately 10 minutes

  • Propulsion effectiveness

    distance travelled per foot propulsion cycle

    same day measure obtained immediately after seat adjustment, approximately 10 minutes

Secondary Outcomes (2)

  • forward propulsion wheelchair skills test score

    same day measure obtained immediately after seat adjustment, approximately 10 minutes

  • propulsion difficulty questionnaire

    same day measure obtained immediately after seat adjustment, approximately 10 minutes

Study Arms (1)

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.

Device: Neutral seat heightDevice: Very low seat heightDevice: Low seat heightDevice: Very high seat heightDevice: High seat height

Interventions

Seat height set relative to participant's leg length with neutral set at the measured lower leg length

Seat Height Intervention

Seat height set relative to participant's leg length, 2" below the measured lower leg length

Seat Height Intervention

Seat height set relative to participant's leg length, 1" below the measured lower leg length

Seat Height Intervention

Seat height set relative to participant's leg length, 2" above the measured lower leg length

Seat Height Intervention

Seat height set relative to participant's leg length, 1" above the measured lower leg length

Seat Height Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Rehabilitation and Arthritis Centre

Halifax, Nova Scotia, B3H 4K4, Canada

Location

Related Publications (2)

  • 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
  • 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.

    PMID: 32594783BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lee Kirby, MD

    Nova Scotia Health Authority, Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single subject - participants will be compared to themselves. STROBE guidelines will be followed.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Staff Physician, Rehabilitation Medicine

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

May 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations