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Clinical Trials/NCT03683160
NCT03683160CompletedNot Applicable

A Cognitive-Augmented Mobility Program (CAMP): Combining Cognitive Strategy Training And Best Evidence Mobility Training To Optimize Long-Term Meaningful Living For People With Stroke

Sunnybrook Health Sciences Centre1 site in 1 country10 target enrollmentStarted: March 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Mean Canadian Occupational Performance Measure scores

Study Overview

Brief Summary

This project will combine best-evidence gait and mobility training with best evidence cognitive strategy training to produce a new cognitive-augmented mobility intervention that is expected to optimize long-term functional mobility outcomes for those living with stroke. More importantly, the new cognitive-augmented mobility program (CAMP) will address two crucial outcomes that do not occur with current approaches: 1. Maintenance of mobility gains after discharge from formal rehabilitation and 2. Transfer of skills learned in rehabilitation to real-world community living. This project will result in a new, fully defined intervention, and will provide effect size and cost estimates to design a future appropriately powered randomized controlled trial (RCT).

Detailed Description

Difficulty walking is a leading cause of activity restriction in survivors of stroke. It is directly related to important functional issues, such as challenges in crossing a street in time, difficulty walking to a bus stop and increased risk of falls. These functional issues can then impact a person's confidence to move around their community, ultimately leading to lower levels of physical activity and potential negative health consequences. The best way to optimize recovery in walking and mobility is not yet known, and there are critical gaps in existing treatments. While some approaches are effective in the short term, strategies to promote the maintenance of improvements are not well established, benefits are usually not transferred beyond the specific skills trained and the specific context in which they were learned, few interventions impact community participation, and cost effectiveness has rarely been investigated. A potential solution exists in combining best-evidence interventions: task-specific gait and mobility training to improve skill quality, cardiorespiratory and strength exercises to improve endurance and speed, and cognitive strategy training to teach problem solving, improve confidence and to ensure long-term maintenance and transfer of skills to home and community settings. The investigators will combine best evidence mobility interventions with best evidence cognitive strategy training to develop and evaluate a new intervention to optimize long-term functional mobility outcomes for those living with stroke. The project consists of two sequential stages: 1) intervention development through literature synthesis; face validity testing using focus groups with patients, family members and expert stroke rehabilitation clinicians; and intervention refinement; followed by 2) feasibility/pilot testing with 10 people more than 6 months post stroke. Anticipated outcomes include a fully developed intervention with the potential to optimize mobility rehabilitation and effect size estimates to permit the design of a future, appropriately-powered randomized controlled trial.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patients aged 18 years of age or older
  • •post stroke
  • •have completed outpatient therapy
  • •can walk a minimum of 3 metres with or without an aid

Exclusion Criteria

  • •patient does not a mobility goal
  • •neurological diagnoses other than stroke
  • •major psychiatric illness
  • •significant dementia (MoCA scores < 21)

Arms & Interventions

Cognitive Augmented Mobility Program

Experimental

CAMP will combine education, one-on-one cognitive strategy training, and a cardiovascular and strength-training program conducted within a group setting. It will be run as a group of up to 6 participants, facilitated by a physiotherapist and a physiotherapy assistant or kinesiologist. It consists of 2 phases with a total of 19 sessions: Intervention Preparation (3 sessions), Active Intervention (16 sessions), and Follow-Up (1 session).

Intervention: Cognitive Augmented Mobility Program (Other)

Outcomes

Primary Outcomes

Mean Canadian Occupational Performance Measure scores

Time Frame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

The Canadian Occupational Performance Measure (COPM) is a self-report measure of performance and satisfaction with self-selected goals. Participants are asked to generate 5 personally meaningful rehabilitation goals and rate their current performance and satisfaction on a scale from 1 to 10. Total scores are the average performance and satisfaction score. Higher scores indicate better outcomes.

Secondary Outcomes

  • Mean 5 metre walk test scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Activity-specific Balance Confidence Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Stroke Impact Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Community Balance and Mobility Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Functional Independence Measure scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean 6-minute walk test scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Berg Balance Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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