Collaborative Power Mobility Innovative Learning OpporTunity (CoPILOT) - A Pilot Study of a New Training Approach (Phase 2)

NCT02982252 | Completed

• 1 other identifier: H14-01702 (Phase 2)
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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, the investigators 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. The investigators 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.

Conditions

Mild Cognitive Impairment

Keywords

Power mobility; Wheelchair skills training; Older adults

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), Up to 5 Weeks (immediate post-intervention)

Secondary Outcomes (5)

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

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

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

  Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)

• Change in Health Utility Index Mark 3 (HUI3)

  Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)

• Change in The Wheelchair Outcome Measure (WhOM)

  Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)

• The Wheeling While Talking Test

  Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)

Study Arms (4)

CoPILOT (6 weeks)

EXPERIMENTAL

Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 6 hours total training time (1 hour training sessions, 3 days per week for 2 weeks).

Behavioral: CoPILOT

Standard of Care (6 weeks)

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 6 hours total training time (1 hour training sessions, 3 days per week for 2 weeks).

CoPILOT (12 weeks)

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 (1 hour training sessions, 4 days per week for 3 weeks).

Behavioral: CoPILOT

Standard of Care (12 weeks)

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 hours total training time (1 hour training sessions, 4 days per week for 3 weeks).

Interventions

CoPILOT BEHAVIORAL

Participants in all groups will receive either six or 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 (12 weeks); CoPILOT (6 weeks)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live in a residential facility
• Have mild to moderate cognitive impairment (MMSE 18-26)
• 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
• Be physically able to operate a powered wheelchair joystick.
• Have a visual or hearing impairment which may compromise training safety
• Do not understand English well enough to complete assessments and/or training.

Sponsors & Collaborators

• University of British Columbia: lead
• Networks of Centres of Excellence of Canada: collaborator
• Alzheimer Society of Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Promobilia Foundation: collaborator
• Rick Hansen Foundation: collaborator

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• William C Miller, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: November 1, 2016
• First Posted: December 5, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CA (1)