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Completed

NCT Number: NCT03683160

A Cognitive-Augmented Mobility Program

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, St. John's Rehab

Toronto, Ontario, M2M 2G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Augmented Mobility Program

Other

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).

Primary outcomes

  1. 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

  1. Mean 5 metre walk test scores

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

    Measure of gait speed in metres per second. Higher scores indicate faster walking speed.

  2. Mean 6-minute walk test scores

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

    Measure of walking endurance in metres walked. Higher scores indicate greater distance traveled.

  3. Mean Berg Balance Scale scores

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

    The Berg Balance Scale (BBS) is a measure of static balance. Participants are asked to complete a series of 14 tasks and are scored from 0 to 4. Total score (min=0; max=56) is calculated by adding the scores of the individual tasks, higher scores indicate better outcomes.

  4. Mean Activity-specific Balance Confidence Scale scores

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

    The Activity-specific Balance Confidence (ABC) Scale is a self-report measure of confidence to perform daily activities without falling. Participants assign a score from 0 to 100 to each of the measure's 16 items and the total score is calculated by obtaining the average score. Higher scores indicate better outcomes.

  5. Mean Community Balance and Mobility Scale scores

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

    The Community Balance and Mobility (CB&M) Scale is a measure of balance and mobility. Participants are asked to perform 13 tasks while a therapist scores their performance. Several tasks require using both sides. The total score (min=0; max=96) is the sum of all task scores and greater scores indicate better outcomes.

  6. Mean Functional Independence Measure scores

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

    The Functional Independence Measure (FIM) is a measure of the amount of assistance required to complete activities of daily living. Participants are asked about the amount of assistance required to complete each of the measure's 18 items and are assigned a score from 1 to 7 for each item. Total scores (min=18; max=126) are the sum of the item scores and greater scores indicate better outcomes.

  7. Mean Stroke Impact Scale scores

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

    The Stroke Impact Scale (SIS) is a self-report measure of perceived impact of stroke on function and everyday life. The SIS is a 56 item measure with 8 subscales measuring strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function. Subscale scores range from 0 to 100. Greater scores indicate better outcomes.

Other outcomes

  1. Acceptability - Participant satisfaction and intent to use

    Time frame: 1 week post-intervention

    Participants will be asked to complete a 2 question survey to gauge their satisfaction with the intervention and their interest in using the skills they learned during the intervention. Scores for each item range from 1 to 5. Higher scores indicate greater satisfaction and intention to use the skills they learned in the future.

  2. Feasibility - Number of participants recruited

    Time frame: Through study completion, up to 9 months

    Total number of participants enrolled in the study

  3. Feasibility - Number of participants who attend the intervention session

    Time frame: Through study completion, up to 9 months

    Total number of participants who attend the intervention sessions

  4. Feasibility - Number of participant withdrawals

    Time frame: Through study completion, up to 9 months

    Number of participant withdrawals and reasons, if any

  5. Feasibility - Number of adverse events

    Time frame: Through study completion, up to 9 months

    Total number of adverse events and reasons, if any

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study 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

Acronym: CAMP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2018
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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