Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users

NCT ID: NCT03856749

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2023-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Although there have been a small number of studies suggesting the important role that caregivers play in assisting wheelchair users with mobility, there has never been a randomized controlled trial (RCT) looking at the effectiveness or cost-utility of wheelchair skills training for caregivers. The overall goal of this study is to correct this knowledge gap and, triggered by the COVID-19 pandemic of 2020, to conduct the training remotely. The main purpose of this study is to test if providing wheelchair skills training remotely to caregivers of manual wheelchair users enhances caregiver-assisted wheelchair skills ability and confidence in comparison to a control group of participants who are receiving usual care and self-study material on wheelchair skills. The investigators will also study whether the benefits of training are still seen at a 6-week follow-up and assess the health-economic impact of caregiver training.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caregivers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-blind randomized controlled trial. Each participant in the study consists of a caregiver and wheelchair user dyad. 1 dyad = 1 manual wheelchair user + his/her caregiver.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
This is a single-blind study. The outcomes assessor will be blind to group allocation. Because of the nature of the study, it will not be possible to blind participants or trainer.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

The wheelchair user and caregiver will be trained together on wheelchair skills using remote technology (Zoom for healthcare and/or Facetime).

Group Type EXPERIMENTAL

Remote wheelchair skills training

Intervention Type OTHER

Prior to the first training session, the trainer will be provided with the results from the assessment immediately preceding training to provide him/her time to individualize the training session. Trainer will provide self-study materials (the Caregiver Handbook and caregiver-training video-recording) and an explanation on how these materials should be used.

The wheelchair user and caregiver will be trained together on wheelchair skills, using the principles of the Wheelchair Skills Training Program, as outlined in the Wheelchair Skills Program Manual using remote technology. Each training session will be with a trainer-to-dyad ratio of 1:1 1 dyad = 1 manual wheelchair user + his/her caregiver. Training will continue until the goals have been met and retained (for at least one subsequent session), using up to 4 training sessions that will each last up to 60 minutes at intervals a minimum of 3 days.

Control

The wheelchair user and caregiver will receive the same self-study materials provided to the Treatment arm. Usual care, which may include wheelchair skills training for both wheelchair users and caregivers( but which often does not do so to an adequate extent) by wheelchair user's clinical therapist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remote wheelchair skills training

Prior to the first training session, the trainer will be provided with the results from the assessment immediately preceding training to provide him/her time to individualize the training session. Trainer will provide self-study materials (the Caregiver Handbook and caregiver-training video-recording) and an explanation on how these materials should be used.

The wheelchair user and caregiver will be trained together on wheelchair skills, using the principles of the Wheelchair Skills Training Program, as outlined in the Wheelchair Skills Program Manual using remote technology. Each training session will be with a trainer-to-dyad ratio of 1:1 1 dyad = 1 manual wheelchair user + his/her caregiver. Training will continue until the goals have been met and retained (for at least one subsequent session), using up to 4 training sessions that will each last up to 60 minutes at intervals a minimum of 3 days.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* be ≥ 18 years of age
* able to communicate in English
* be willing to participate and be committed to setting regularly scheduled times for the study activities
* will need to have the appropriate connectivity for the remote training and testing (i.e. telephone, limited-access e-mail and internet).


* a person who uses a manual wheelchair
* be expected to continue to use a manual wheelchair at least part-time in the coming months
* requires no more than minimal assistance for communication and auditory comprehension


-must be a caregiver (e.g. a family member, friend, volunteer or regular homecare worker) who spends an average total of at least 2 hours per week with the manual wheelchair user that includes manual wheelchair mobility.

Exclusion Criteria

* fail to complete the baseline (T1) assessment
* have unstable medical conditions (e.g. angina, seizures) that might make the use of a manual wheelchair dangerous
* emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
* have a medical condition that is likely to deteriorate in the three months following enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IWK Health Centre

OTHER

Sponsor Role collaborator

Lee Kirby

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lee Kirby

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nova Scotia Rehabilitation Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Kirby RL, Smith C, Miller MD, Osmond D, Sherman MA, Parker K, Koto PS, Theriault CJ, Sandila N. Wheelchair skills training for caregivers of manual wheelchair users: a randomized controlled trial comparing self-study and remote training. Disabil Rehabil Assist Technol. 2024 Nov;19(8):2896-2903. doi: 10.1080/17483107.2024.2321272. Epub 2024 Feb 29.

Reference Type DERIVED
PMID: 38420947 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WSP2019-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Team Work and Creative Self-Efficacy
NCT07318246 RECRUITING NA
Comprehensive Surgical Coaching
NCT01875679 COMPLETED NA