Clinical trial NCT03683160: A Cognitive-Augmented Mobility Program
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke, mobility, cognitive strategy training
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm design with two blocks.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mean Canadian Occupational Performance Measure scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Secondary outcomes:
measure: Mean 5 metre walk test scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
measure: Mean 6-minute walk test scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
measure: Mean Berg Balance Scale scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
measure: Mean Activity-specific Balance Confidence Scale scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
measure: Mean Community Balance and Mobility Scale scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
measure: Mean Functional Independence Measure scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
measure: Mean Stroke Impact Scale scores
timeFrame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Other outcomes:
measure: Acceptability - Participant satisfaction and intent to use
timeFrame: 1 week post-intervention
measure: Feasibility - Number of participants recruited
timeFrame: Through study completion, up to 9 months
measure: Feasibility - Number of participants who attend the intervention session
timeFrame: Through study completion, up to 9 months
measure: Feasibility - Number of participant withdrawals
timeFrame: Through study completion, up to 9 months
measure: Feasibility - Number of adverse events
timeFrame: Through study completion, up to 9 months
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, St. John's Rehab
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Sara McEwen, PhD
role: PRINCIPAL_INVESTIGATOR
References: