NCT02320786

Brief Summary

Losing the ability to walk can lead to fewer opportunities to socialize with friends and family and participate in the community. When this happens, powered wheelchairs can provide access to homes and communities, contributing to health and well-being. Training by a qualified occupational therapist allows an individual to use a powered wheelchair safely and effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time consuming for people with cognitive and physical challenges. In this study, we will ask participants with cognitive impairments to complete training with an occupational therapist using either a shared control wheelchair or training methods according to the standard of care. We believe shared control training, entitled Collaborative Powered mobility Innovative Learning OpporTunity (CoPILOT) will enhance driving skill while maximizing safety learning. CoPILOT has the potential to enable people to participate more in their day to day lives and regain mobility independence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_1

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

December 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

3.2 years

First QC Date

December 10, 2014

Last Update Submit

July 19, 2024

Conditions

Keywords

Power mobilityWheelchair skills trainingSpinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Change in Power-mobility Indoor Driving Assessment (PIDA)

    The PIDA covers specific tasks required for functional indoor driving, which are specific to the environment (i.e. accessing the bed from the right and left, and approaching the closet and dresser in the bedroom). The PIDA has been evaluated for content and face validity, has good inter-rater (ICC 0.87) and fair intra-rater (ICC 0.67) reliability.55. We aim to explore the potential usefulness of this outcome measure for this population, in this environment, for inclusion in future clinical trials.

    Baseline (pre-randomization), 5 weeks (immediate post-intervention)

Secondary Outcomes (6)

  • Change in Wheelchair Skills Test Questionnaire (WST-P-Q)

    Baseline (pre-randomization), 5 weeks (immediate post-intervention)

  • Change in Wheelchair-use Confidence Scale (WheelCon-P )

    Baseline (pre-randomization), 5 weeks (immediate post-intervention)

  • Change in Health Utility Index Mark 3 (HUI3)

    Baseline (pre-randomization), 5 weeks (immediate post-intervention)

  • Change in The Wheelchair Outcome Measure (WhOM)

    Baseline (pre-randomization), 5 weeks (immediate post-intervention)

  • The Wheeling While Talking Test

    Baseline (pre-randomization), 5 weeks (immediate post-intervention)

  • +1 more secondary outcomes

Study Arms (2)

CoPILOT

EXPERIMENTAL

Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 12 hours total training time (one hour, four times per week for three weeks).

Behavioral: CoPILOT

Standard of Care

NO INTERVENTION

Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair, consisting of 12 hour protocols in a standard power wheelchair (one hour, four times per week for three weeks).

Interventions

CoPILOTBEHAVIORAL

Participants in both groups will receive twelve hours of training in a standard powered wheelchair however the CoPILOT groups will use remote control technology we have developed. The technology provides the trainer with remote control of wheelchair speed and direction allowing the trainer to override the participant's actions as needed to ensure safe error-free shared controlled wheelchair training. The CoPILOT approach will accommodate varied learning needs, as per adult learning principles, while decreasing trainer input until the participant can complete tasks independently.

CoPILOT

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
The following criteria MUST be met in order for the participant to be eligible for the study: 1. Have sustained a spinal cord injury; and 2. Have mild to moderate cognitive impairment (MMSE 18-26); and 3. Be new to powered wheelchairs (no full time driving experience for 3 weeks or more within the past five years) or previously denied a powered wheelchair (due to cognitive impairments impacting ability to learn or inability to learn the required skills); and 4. Be physically able to operate a powered wheelchair joystick. Participants will not be eligible for the study if ANY of the following criteria are met: 1. Have a visual or hearing impairment which may compromise training safety; OR 2. Do not understand English well enough to complete assessments and/or training.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Related Publications (1)

  • Smith EM, Tregobov N, Miller WC. A feasibility study of a shared control powered wheelchair training program for individuals with spinal cord injury. Spinal Cord. 2026 Jan;64(1):40-45. doi: 10.1038/s41393-025-01134-5. Epub 2025 Nov 12.

MeSH Terms

Conditions

Cognitive DysfunctionSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • William C Miller, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 19, 2014

Study Start

October 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations