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

NCT ID: NCT02982252

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-10-01

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.

Detailed Description

Background: Powered wheelchairs can improve participation in daily life, increase quality of life, and add 'life to years' for individuals with SCI. Cognitive limitations, associated with advanced age at the time of a spinal cord injury or comorbid traumatic brain injury, impair learning and may prevent an individual from acquiring or maintaining skills necessary to drive a powered mobility device. Standard power wheelchair training, limited by time, equipment and budget constraints, may not meet the learning needs of individuals with cognitive impairment, preventing an individual from obtaining use of a powered wheelchair, impacting independence and quality of life. The total system cost of procuring a power wheelchair can range from $10,000 - $30,000; suboptimal use resulting from inadequate training is a poor use of resources and comes at a substantial social price. The Collaborative Power mobility Innovative Learning OpporTunity (CoPILOT) is a training approach utilizing shared control wheelchair technology and allows a therapist to provide an error-free learning experience for individuals in their own environments, while maintaining safety of the user and the individuals around them. Using shared control technology, the wheelchair user remains in control of the wheelchair while learning to drive, except in cases where the trainer overrides the control (using a remote controlled interface) to maintain safety and provide targeted learning opportunities.

Purpose and Objectives: The purpose of this study is to obtain pilot data for a larger randomized control trial of a shared control power wheelchair training program (CoPILOT) for improving power wheelchair mobility skills among novice power wheelchair users with comorbid cognitive impairment compared to standard of care. Collection of pilot data is necessary prior to moving forward with a larger randomized controlled trial (RCT).

Hypotheses: The investigators expect the intervention protocol will be feasible for a larger randomized control trial. Compared to the standard of care group, the investigators expect the CoPILOT group will experience significant improvement in power wheelchair skill capacity. The investigators also expect the CoPILOT group will experience improvements in wheelchair skill safety, confidence, capacity for divided attention tasks, and health related quality of life, compared to the standard of care participants.

Methods: This feasibility study will use an evaluator blind parallel RCT. New power wheelchair users with mild to moderate cognitive impairment will be recruited from the GF Strong or Vancouver General Hospital Spinal Cord Injury patient population. Participants will be randomly assigned to a CoPILOT (shared control training) group or standard of care group. All training will be completed by qualified occupational therapist trainers. Participants in both groups will receive either 6 or 12 hours of training in a standard powered wheelchair; however, the CoPILOT groups will use remote control technology the investigators have developed. Post-Treatment Qualitative Interviews will be conducted. Questions will be related to protocol administration and use of the CoPILOT approach and shared control technology, including necessary modifications.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CoPILOT (6 weeks)

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).

Group Type: EXPERIMENTAL

CoPILOT

Intervention Type: 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.

Standard of Care (6 weeks)

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

CoPILOT (12 weeks)

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).

Group Type: EXPERIMENTAL

CoPILOT

Intervention Type: 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.

Standard of Care (12 weeks)

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CoPILOT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Live in a residential facility

2. Have mild to moderate cognitive impairment (MMSE 18-26)

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.

Exclusion Critera:

1. Have a visual or hearing impairment which may compromise training safety

2. Do not understand English well enough to complete assessments and/or training.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Networks of Centres of Excellence of Canada

OTHER

Sponsor Role: collaborator

Alzheimer Society of Canada

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Promobilia Foundation

OTHER

Sponsor Role: collaborator

Rick Hansen Foundation

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

William C. Miller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William C Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H14-01702 (Phase 2)

Identifier Type: -

Identifier Source: org_study_id