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A Cognitive-Augmented Mobility Program (CAMP)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Augmented Mobility Program
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, mobility, cognitive strategy training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sunnybrook Health Sciences Centre, St. John's Rehab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Augmented Mobility Program

Arm Description

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).

Outcomes

Primary Outcome Measures

Mean Canadian Occupational Performance Measure scores
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 Outcome Measures

Mean 5 metre walk test scores
Measure of gait speed in metres per second. Higher scores indicate faster walking speed.
Mean 6-minute walk test scores
Measure of walking endurance in metres walked. Higher scores indicate greater distance traveled.
Mean Berg Balance Scale scores
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.
Mean Activity-specific Balance Confidence Scale scores
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.
Mean Community Balance and Mobility Scale scores
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.
Mean Functional Independence Measure scores
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.
Mean Stroke Impact Scale scores
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.

Full Information

First Posted
September 5, 2018
Last Updated
September 21, 2018
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03683160
Brief Title
A Cognitive-Augmented Mobility Program
Acronym
CAMP
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, mobility, cognitive strategy training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm design with two blocks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Augmented Mobility Program
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Cognitive Augmented Mobility Program
Intervention Description
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 Outcome Measure Information:
Title
Mean Canadian Occupational Performance Measure scores
Description
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.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Secondary Outcome Measure Information:
Title
Mean 5 metre walk test scores
Description
Measure of gait speed in metres per second. Higher scores indicate faster walking speed.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Title
Mean 6-minute walk test scores
Description
Measure of walking endurance in metres walked. Higher scores indicate greater distance traveled.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Title
Mean Berg Balance Scale scores
Description
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.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Title
Mean Activity-specific Balance Confidence Scale scores
Description
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.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Title
Mean Community Balance and Mobility Scale scores
Description
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.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Title
Mean Functional Independence Measure scores
Description
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.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Title
Mean Stroke Impact Scale scores
Description
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.
Time Frame
1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Other Pre-specified Outcome Measures:
Title
Acceptability - Participant satisfaction and intent to use
Description
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.
Time Frame
1 week post-intervention
Title
Feasibility - Number of participants recruited
Description
Total number of participants enrolled in the study
Time Frame
Through study completion, up to 9 months
Title
Feasibility - Number of participants who attend the intervention session
Description
Total number of participants who attend the intervention sessions
Time Frame
Through study completion, up to 9 months
Title
Feasibility - Number of participant withdrawals
Description
Number of participant withdrawals and reasons, if any
Time Frame
Through study completion, up to 9 months
Title
Feasibility - Number of adverse events
Description
Total number of adverse events and reasons, if any
Time Frame
Through study completion, up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara McEwen, PhD
Organizational Affiliation
Sunnybrook Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre, St. John's Rehab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 2G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Cognitive-Augmented Mobility Program

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