Sequelae of StrokeNCT01818271
Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility Post Stroke
A study testing conventional physical therapy and community-based group rehabilitation in people with Sequelae of Stroke, run by University of Manitoba at 2 sites in Canada.
Trial summary
Stroke patients clearly benefit from intensive and coordinated inpatient care. While inpatient rehabilitation care is the preferred form for many patients post-stroke, due to access and financial barriers, many patients do not have this option. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Sequelae of Stroke
- What is being tested?
- conventional physical therapy and community-based group rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2013to Sep 2015
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- community dwelling individuals, who have suffered a single stroke of thrombic -embolic or hemorrhagic origin in the last 3-12 months and are waiting for outpatient rehabilitation ,
- Aged 50-70 years,
- Montreal Cognitive Assessment score greater than 26,
- English-speaking and possess the ability to understand the nature of the study and provide informed consent,
- Independent in sit to stand transfer and ambulatory functions, with or without an assistive device (cane or walker), f ) Gait speed (average over 25 meters) between 0.3 and 0.8 m/s and Berg Balance Scale score of less than 45.
Who cannot join
- Any medical condition or disability that prevents participation in an exercise program. For example, a reported medical history of current treatment for cancer, kidney disease, recent fracture, uncontrolled diabetes or seizure disorder, uncontrolled cardiovascular-related problems .
- -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
School of Medical Rehabilitation , University of Mantioba
Winnipeg, Manitoba, R3e 0T6
Riverview Health Centre
Winnipeg, Manitoba, R3T 1a3
About this study
Official title: Phase 1 Study of the Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility; as an Alternate to Out-patient Rehabilitation Post Stroke;
Stroke patients clearly benefit from intensive and coordinated inpatient care. While inpatient rehabilitation care is the preferred form for many patients post-stroke, due to access and financial barriers, many patients do not have this option. Community, outpatient rehabilitation programs will allow the patients with moderately disabling strokes the opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation , while allowing some patients with mild disability to avoid inpatient rehabilitation completely.
Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of treating adults who have suffered a single stroke using the following essential treatment components; a) community setting, b) group activity program, c) flexible, task-specific, computer-based exercise regime This program is designed to allow an extension of the in-patient rehabilitation experience to a community-based setting, in a cost-effective manner using paraprofessional staff and rehabilitation specialists, to provide a challenging, functional program to promote recovery and independence from physical impairments affecting balance and walking.
Read more
The specific objectives are to:
- assess the benefits and feasibility of the multi-functional group exercise intervention for balance and mobility in a community setting. Secondary objectives
- identify effective combinations of exercises \& activities that translate to increased abilities and participation levels.
Hypothesis: Intense training targeting standing balance, and walking will significantly improve stroke clients' functional mobility. Training in a group setting and incorporating interactive and engaging computer gaming further provides the benefits of motivation and peer support while providing treatment in a cost effective manner.
- Conditions
- Sequelae of Stroke
- Being tested
- conventional physical therapy, community-based group rehabilitation
- Keywords
- community-stroke-rehabilitation,, group-exercise,, balance-mobility-exercise,, instrumented treadmill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyBehavioural
will receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises
community-based group rehabilitationBehavioural
Group training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically:
- Advanced dynamic tasks, including stepping and other transitional tasks to treadmill \& over ground walking) with use of various inexpensive exercise "assistive" equipment such as mini-exercise stepper or elliptical machines.
- Treadmill walking exercise program.
| Study group | Role | What they receive |
|---|---|---|
| conventional physical Therapy | Active comparator | will receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises Receives: Behavioral: conventional physical therapy |
| community-based group rehabilitation | Experimental | Group training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically:
* Advanced dynamic tasks, including stepping and other transitional tasks to treadmill \& over ground walking) with use of various inexpensive exercise "assistive" equipment such as mini-exercise stepper or elliptical machines.
* Treadmill walking exercise program. Receives: Behavioral: community-based group rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Proportion of participants with an improved functional level of walking As per LEAPS multi-centre RCT.47 Improved functional level was defined as; (a) the ability to walk independently at a speed of 0.8 m per second or faster for persons with initially moderate gait impairment , or (b) ability to walk independently at a speed of 0.4 m per second or faster for persons with initially severe gait impairment. These transitions are associated with improvements in home or community ambulation, functional status, and quality of life.50
Measured: pre and post intervention of 8 weeks
Stroke Impact Scale
This scale is a self reported, stroke specific, valid, reliable, and responsive measure that includes 59 items and assesses eight domains related to activities and participation.
Measured: Pre and post intervention of 8 weeks
Secondary outcomes (2)
Berg Balance Scale
Measured: pre and post intervention of 8 weeks
Timed Up and Go Test
Measured: Pre and Post intervention of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sequelae of StrokeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Responsible party
- Sponsor
- Investigators
- Tony Szturm Szturm, PT, PhD, Principal investigator, Faculty of Medicine University of ManitobaSepideh Pooyania, MD, Principal investigator, Faculty of Medicine University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818271
- Sponsor's protocol ID
- Hr2013:086
- Status last verified
- Mar 2013
- First submitted
- 21 Mar 2013
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility; as an Alternate to Out-patient Rehabilitation Post Stroke;
- ClinicalTrials.gov ID
- NCT01818271
- Acronym / sponsor ID
- Hr2013:086
- Conditions
- Sequelae of Stroke
- Keywords
- community-stroke-rehabilitation,, group-exercise,, balance-mobility-exercise,, instrumented treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Mar 2013 (estimated)
- 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.
Stroke patients clearly benefit from intensive and coordinated inpatient care. While inpatient rehabilitation care is the preferred form for many patients post-stroke, due to access and financial barriers, many patients do not have this option. Community, outpatient rehabilitation programs will allow the patients with moderately disabling strokes the opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation , while allowing some patients with mild disability to avoid inpatient rehabilitation completely.
Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of treating adults who have suffered a single stroke using the following essential treatment components; a) community setting, b) group activity program, c) flexible, task-specific, computer-based exercise regime This program is designed to allow an extension of the in-patient rehabilitation experience to a community-based setting, in a cost-effective manner using paraprofessional staff and rehabilitation specialists, to provide a challenging, functional program to promote recovery and independence from physical impairments affecting balance and walking.
The specific objectives are to:
- assess the benefits and feasibility of the multi-functional group exercise intervention for balance and mobility in a community setting. Secondary objectives
- identify effective combinations of exercises \& activities that translate to increased abilities and participation levels.
Hypothesis: Intense training targeting standing balance, and walking will significantly improve stroke clients' functional mobility. Training in a group setting and incorporating interactive and engaging computer gaming further provides the benefits of motivation and peer support while providing treatment in a cost effective manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physical Therapy | Active comparator | Behavioral: conventional physical therapywill receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises |
| community-based group rehabilitation | Experimental | Behavioral: community-based group rehabilitationGroup training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically: * Advanced dynamic tasks, including stepping and other transitional tasks to treadmill \& over ground walking) with use of various inexpensive exercise "assistive" equipment such as mini-exercise stepper or elliptical machines. * Treadmill walking exercise program. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- community dwelling individuals, who have suffered a single stroke of thrombic -embolic or hemorrhagic origin in the last 3-12 months and are waiting for outpatient rehabilitation ,
- Aged 50-70 years,
- Montreal Cognitive Assessment score greater than 26,
- English-speaking and possess the ability to understand the nature of the study and provide informed consent,
- Independent in sit to stand transfer and ambulatory functions, with or without an assistive device (cane or walker), f ) Gait speed (average over 25 meters) between 0.3 and 0.8 m/s and Berg Balance Scale score of less than 45.
Key exclusion criteria (2 listed)
- Any medical condition or disability that prevents participation in an exercise program. For example, a reported medical history of current treatment for cancer, kidney disease, recent fracture, uncontrolled diabetes or seizure disorder, uncontrolled cardiovascular-related problems .
- -
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 |
|---|---|---|
| conventional physical therapywill receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises | Behavioural | conventional physical Therapy |
| community-based group rehabilitationGroup training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically: * Advanced dynamic tasks, including stepping and other transitional tasks to treadmill \& over ground walking) with use of various inexpensive exercise "assistive" equipment such as mini-exercise stepper or elliptical machines. * Treadmill walking exercise program. | Behavioural | community-based group rehabilitation |
Primary outcome
Gait speed
Time frame: pre and post intervention of 8 weeks
Proportion of participants with an improved functional level of walking As per LEAPS multi-centre RCT.47 Improved functional level was defined as; (a) the ability to walk independently at a speed of 0.8 m per second or faster for persons with initially moderate gait impairment , or (b) ability to walk independently at a speed of 0.4 m per second or faster for persons with initially severe gait impairment. These transitions are associated with improvements in home or community ambulation, functional status, and quality of life.50
Stroke Impact Scale
Time frame: Pre and post intervention of 8 weeks
This scale is a self reported, stroke specific, valid, reliable, and responsive measure that includes 59 items and assesses eight domains related to activities and participation.
2 secondary outcomes
Berg Balance Scale
Time frame: pre and post intervention of 8 weeks
Timed Up and Go Test
Time frame: Pre and Post intervention of 8 weeks
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 21 Dec 2015.
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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.
Tony Szturm Szturm, PT, PhD principal investigator
Faculty of Medicine University of Manitoba
Sepideh Pooyania, MD principal investigator
Faculty of Medicine University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy and community-based group rehabilitation in people with Sequelae of Stroke, run by University of Manitoba at 2 sites 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 5 inclusion and 2 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Gait speed (time frame: pre and post intervention of 8 weeks). The study lists 2 primary outcomes in all. 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 21 Dec 2015.