Clinical trial NCT02320786: Collaborative Power Mobility Innovative Learning OpporTunity (CoPILOT) - A Pilot Study of a New Training Approach (Phase 1)
Official title: Collaborative Power Mobility Innovative Learning OpporTunity (CoPILOT) - A Pilot Study of a New Training Approach (Phase 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Power Wheelchair
Mild Cognitive Impairment
Spinal Cord Injuries
Keywords: Power mobility
Wheelchair skills training
Spinal Cord Injury
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Networks of Centres of Excellence of Canada
name: Alzheimer Society of Canada
name: Canadian Institutes of Health Research (CIHR)
name: Promobilia Foundation
name: Rick Hansen Foundation
First posted: 2014-12-19
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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: Our purpose 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: We expect the intervention protocol will be feasible for a larger randomized control trial. Compared to the standard of care group, we expect the CoPILOT group will experience significant improvement in power wheelchair skill capacity. We 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: Our 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 12 hours of training in a standard powered wheelchair; however, the CoPILOT groups will use remote control technology we 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Power-mobility Indoor Driving Assessment (PIDA)
timeFrame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Secondary outcomes:
measure: Change in Wheelchair Skills Test Questionnaire (WST-P-Q)
timeFrame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
measure: Change in Wheelchair-use Confidence Scale (WheelCon-P )
timeFrame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
measure: Change in Health Utility Index Mark 3 (HUI3)
timeFrame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
measure: Change in The Wheelchair Outcome Measure (WhOM)
timeFrame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
measure: The Wheeling While Talking Test
timeFrame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
measure: Sensory data
timeFrame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William C Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: