StrokeCAMPNCT03683160
A Cognitive-Augmented Mobility Program
A study testing Cognitive Augmented Mobility Program in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive Augmented Mobility Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patient does not a mobility goal
- neurological diagnoses other than stroke
- major psychiatric illness
- significant dementia (MoCA scores < 21)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre, St. John's Rehab
Toronto, Ontario, M2M 2G1
About this study
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
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).
Read the 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.
- Conditions
- Stroke
- Being tested
- Cognitive Augmented Mobility Program
- Keywords
- Stroke, mobility, cognitive strategy training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Augmented Mobility ProgramOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cognitive Augmented Mobility Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Secondary outcomes (7)
Mean 5 metre walk test scores
Measure of gait speed in metres per second. Higher scores indicate faster walking speed.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Mean 6-minute walk test scores
Measure of walking endurance in metres walked. Higher scores indicate greater distance traveled.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
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.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
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.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
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.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
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.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
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.
Measured: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Mar 2017
- Primary completion4 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm design with two blocks.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara McEwen, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683160
- Sponsor's protocol ID
- 446-2016
- Acronym
- CAMP
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03683160
- Acronym / sponsor ID
- CAMP / 446-2016
- Conditions
- Stroke
- Keywords
- Stroke, mobility, cognitive strategy training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm design with two blocks.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Augmented Mobility Program | Experimental | Other: Cognitive Augmented Mobility ProgramCAMP 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- patient does not a mobility goal
- neurological diagnoses other than stroke
- major psychiatric illness
- significant dementia (MoCA scores < 21)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Augmented Mobility ProgramCAMP 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). | Other | Cognitive Augmented Mobility Program |
Primary outcome
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.
7 secondary outcomes
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
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
Mean Berg Balance Scale scores
Time frame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
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
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
Mean Functional Independence Measure scores
Time frame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Mean Stroke Impact Scale scores
Time frame: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
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Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara McEwen, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Augmented Mobility Program in people with Stroke, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.