CVA (Cerebrovascular Accident)NCT04042961
Reactive Balance Training and Fitness
A study testing Reactive balance training and Aerobic and strength training (AST) in people with CVA (Cerebrovascular Accident), run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
People with stroke should exercise to maintain function and reduce the risk of another stroke. Different types of exercise target different components of fitness, such as aerobic, strength, and balance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA (Cerebrovascular Accident)
- What is being tested?
- Reactive balance training and Aerobic and strength training (AST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 16 May 2025
- 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
- Community-dwelling adults with chronic stroke (>6 months post-stroke).
- Able to stand independently without upper-limb support for >30 seconds.
- Able to tolerate at least 10 postural perturbations while wearing a safety harness.
Who cannot join
- >2.1m tall and/or weighing >150kg (limits of the safety harness system).
- Other neurological condition that could affect balance control (e.g., Parkinson's disease).
- Lower extremity amputation.
- Cognitive, language or communication impairments affecting understanding instructions.
- Recent (last 6 months) significant illness, injury or surgery.
- Severe osteoporosis, defined by diagnosis of osteoporosis with fracture.
Show all 12Show fewer
- Severe uncontrolled hypertension, or uncontrolled diabetes.
- Contraindications to exercise testing, such as symptomatic aortic stenosis, complex life-threatening arrhythmias, unstable angina, or orthostatic blood pressure decrease of >20 mmHg with symptoms.
- Acute or chronic illness or injury likely to be exacerbated by exercise (e.g., recent lower-extremity fracture).
- Currently attending in- or out-patient physiotherapy, in which they receive aerobic training, balance training or strength training for lower limb.
- Significant exercise participation: current physical activity levels that meet the recommended guidelines (at least 150 minutes of moderate-to-vigorous or at least 75 minutes of vigorous physical activity/week) as calculated using the moderate and vigorous components of the Leisure Time Exercise Questionnaire (LTEQ) in the month prior to starting the study.
- Received perturbation training at Toronto Rehab <1 year previously.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Reactive Balance Training on Physical Fitness Post-stroke
People with stroke should exercise to maintain function and reduce the risk of another stroke. Different types of exercise target different components of fitness, such as aerobic, strength, and balance. Post-stroke exercise guidelines exist for each type of exercise separately (eg, brisk walking as aerobic exercise, resistance training for strength, and Tai Chi for balance). Meeting these recommendations means spending a lot of time exercising, and people with stroke say that lack of time and fatigue are barriers to exercise. It is possible to target several components of fitness with one type of exercise.
'Reactive balance training' (RBT) is a type of exercise that improves control of reactions that are needed to prevent a fall after losing balance, and is the only type of exercise with potential to prevent falls in daily life post-stroke. Because RBT involves repeated whole-body movements it may have similar aerobic benefit as other exercises using whole-body movements (eg, brisk walking). Also, leg muscles need to generate a lot of force to make rapid steps in RBT; repeatedly generating this force may help to improve strength.
The purpose of this study is to determine if RBT improves two important components of fitness among people with chronic stroke: aerobic capacity and strength. The investigators expect that the improvements in aerobic capacity and strength after RBT will not be any worse than after an exercise program that specifically targets aerobic fitness and strength. A secondary purpose of this study is to determine the effects of RBT compared to aerobic and strength training on balance control and balance confidence. The investigators expect that RBT will lead to greater improvements in balance control and balance confidence than an aerobic and strength training program.
Read the detailed description
This is an assessor-blind randomized non-inferiority trial with an internal pilot study. Research activities will take place at the Toronto Rehabilitation Institute and the University of Toronto. For the internal pilot study, we will initially recruit 20 participants with chronic stroke and randomly assign them to one of two groups: 1) RBT, or 2) AST. Cardiorespiratory fitness, lower-extremity strength, balance control, and balance confidence will be measured pre- and post-intervention. We will calculate the final target sample size using the variability observed in this internal pilot. Additionally, a Trial Steering Committee will determine the criteria for the progression from the internal pilot to the main study, and will decide on the continuation of the internal pilot with or without modifications based on those pre-defined criteria (e.g., criteria based on feasibility or preliminary evidence of effect of the interventions from examination of effect sizes).
- Conditions
- CVA (Cerebrovascular Accident)
- Being tested
- Reactive balance training, Aerobic and strength training (AST)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive balance trainingOther
A variety of tasks will be included to induce external or internal perturbations. External perturbations will be caused by forces outside participants' control (e.g. a push or pull from the physiotherapist). Internal perturbations are when the participant fails to control the centre of mass-base of support relationship during voluntary movement; e.g., 'agility' tasks such as kicking a soccer ball. Each session will include a five-minute warm-up, at least 60 perturbations, and a five-minute cool-down. The difficulty of the task will be set such that participants will 'fail' to recover balance ~50% of the time; 'failure' is defined as use of an upper extremity response, use of external assistance (i.e. from the overhead harness or physiotherapist), or taking more than 2 steps to regain stability. Training tasks will progressed by increasing the perturbation magnitude, including cognitive or movement tasks, or imposing sensory or environmental challenges (e.g. eyes closed, obstacles).
Aerobic and strength training (AST)Other
AST sessions will consist of 30 minutes of aerobic and 30 minutes of strength training.
Aerobic training: Aerobic training will be done using treadmill walking or combination of modalities (e.g. cycling or recumbent stepping) for those unable to maintain the target heart rate with walking. The heart rate that occurred at the ventilatory threshold (V̇O2VT) during the cardiopulmonary exercise test will be used to prescribe intensity. In the absence of a discernible V̇O2VT a combination of the following will be used: 60-80% of heart rate reserve, peak oxygen uptake, and rating of perceived exertion of 11-16 (Borg 6-20 scale). Prescriptions will be initially progressed by increasing duration to ≥20 minutes and then increasing intensity to target heart rate.
Resistance training: Participants will be prescribed 1-2 sets of 8 exercises per session (squat, heel raise, ankle dorsiflexion, knee extension and flexion, abdominal curl-up, wall push up, bicep curl), at 70% of 1 repetition maximum.
| Study group | Role | What they receive |
|---|---|---|
| Reactive balance training | Experimental | Not described Receives: Other: Reactive balance training |
| Aerobic and strength training | Active comparator | Not described Receives: Other: Aerobic and strength training (AST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
A symptom-limited cardiopulmonary exercise test (CPET) will be performed. The CPET will be medically supervised. It will be conducted on the same modality on subsequent assessments and at the same time of day as the supervised exercise classes to minimize effects of heart rate altering medication on exercise prescription. Resistance will be increased every minute until either the patient indicates that he/she would like to stop or abnormalities appear that necessitate discontinuing the test. Breath-by-breath gas samples will be collected via calibrated metabolic cart to determine V̇O2peak and V̇O2VT.
Measured: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Lower extremity strength
Peak isokinetic torque will be measured using a isokinetic dynamometer. Participants will be seated in the chair (hips at approximately 90 degrees) with the axis of rotation of the dynamometer aligned to the femoral condyles. Shoulder straps will secure the torso and a thigh strap over the active leg will minimize compensatory movements during testing. The inactive leg will be positioned at 90 degrees knee flexion and held in place with a padded bar below the seat. Peak isokinetic muscle torque at a speed of 60 degrees/s will be assessed. Two to three warm-up contractions will be performed at ~50-75% of perceived maximum effort. This will be followed by 5 maximal efforts to obtain peak torque. A one-minute rest will be given between trials to minimize fatigue. The highest torque achieved among the three maximal trials will be used as the peak isokinetic torque. The task will be performed for both legs.
Measured: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Secondary outcomes (7)
Berg balance scale
Construct: Functional balance Scale range: 0-56 Higher values represent improved outcome
Measured: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Mini-Balance Evaluation Systems Test
Construct: Anticipatory balance control, reactive balance control, gait, and sensory orientation in balance Scale range: 0-28 (total), 0-6 (anticipatory balance control), 0-6 (reactive balance control), 0-10 (gait), 0-6 (sensory orientation) Higher values represent improved outcome The total score is created by adding the sub-scale scores
Measured: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Six-minute walk test
Measured: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Activities-specific Balance Confidence scale
Construct: balance confidence Scale range: 0-100 Higher values represent improved outcome
Measured: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Falls in daily life
A fall is defined as "an event that results in a person coming to rest unintentionally on the ground or other lower level". Participants will complete a 12-month falls monitoring period after completing the initial training period. Participants will be provided stamped address postcards containing a calendar to record falls, which they will complete daily. Participants will return each postcard to the research team fortnightly. If a participant does not complete the event tracking within two weeks the research assistant will call them. In this telephone call, the research assistant will try to ascertain if the participant has experienced a fall in the previous two weeks. Participants who report a fall on the calendar will be contacted by the to complete a questionnaire asking about the circumstances of the fall.
Measured: For 12 months post-intervention
Physical Activity Scale for Individuals with Physical Disabilities
Construct: physical activity in daily life Scale range: not applicable (the maximum score that is technically achievable would not be feasible) Higher scores represent improved outcome
Measured: 4 months, 8 months, and 12 months post-intervention
Subjective Index of Physical and Social Outcome
Construct: participation Scale range: 0-40 (total); 0-20 (social sub-scale), 0-20 (physical sub-scale) Higher scores represent improved outcome The total score is the sum of the sub-scale scores
Measured: 4 months, 8 months, and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Sep 2019
- Primary completion28 May 2024
- Study completion16 May 2025
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Avril Mansfield, Toronto Rehabilitation Institute
- Investigators
- Avril Mansfield, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042961
- Sponsor's protocol ID
- 18-5784
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2019
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansfield A, Aqui A, Danells CJ, Knorr S, Centen A, DePaul VG, Schinkel-Ivy A, Brooks D, Inness EL, Mochizuki G. Does perturbation-based balance training prevent falls among individuals with chronic stroke? A randomised controlled trial. BMJ Open. 2018 Aug 17;8(8):e021510. doi: 10.1136/bmjopen-2018-021510.
PubMed 30121600Marzolini S, Brooks D, Oh P, Jagroop D, MacIntosh BJ, Anderson ND, Alter D, Corbett D. Aerobic With Resistance Training or Aerobic Training Alone Poststroke: A Secondary Analysis From a Randomized Clinical Trial. Neurorehabil Neural Repair. 2018 Mar;32(3):209-222. doi: 10.1177/1545968318765692. Epub 2018 Mar 30.
PubMed 29600726Boyne P, Reisman D, Brian M, Barney B, Franke A, Carl D, Khoury J, Dunning K. Ventilatory threshold may be a more specific measure of aerobic capacity than peak oxygen consumption rate in persons with stroke. Top Stroke Rehabil. 2017 Mar;24(2):149-157. doi: 10.1080/10749357.2016.1209831. Epub 2016 Jul 25.
PubMed 27454553Flansbjer UB, Holmback AM, Downham D, Lexell J. What change in isokinetic knee muscle strength can be detected in men and women with hemiparesis after stroke? Clin Rehabil. 2005 Aug;19(5):514-22. doi: 10.1191/0269215505cr854oa.
PubMed 16119407Barzideh A, Marzolini S, Danells C, Jagroop D, Huntley AH, Inness EL, Mathur S, Mochizuki G, Oh P, Mansfield A. Effect of reactive balance training on physical fitness poststroke: study protocol for a randomised non-inferiority trial. BMJ Open. 2020 Jun 30;10(6):e035740. doi: 10.1136/bmjopen-2019-035740.
PubMed 32606059
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reactive Balance Training on Physical Fitness Post-stroke
- ClinicalTrials.gov ID
- NCT04042961
- Acronym / sponsor ID
- 18-5784
- Conditions
- CVA (Cerebrovascular Accident)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- University of Toronto, Heart and Stroke Foundation of Canada
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 2 Aug 2019 (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.
People with stroke should exercise to maintain function and reduce the risk of another stroke. Different types of exercise target different components of fitness, such as aerobic, strength, and balance. Post-stroke exercise guidelines exist for each type of exercise separately (eg, brisk walking as aerobic exercise, resistance training for strength, and Tai Chi for balance). Meeting these recommendations means spending a lot of time exercising, and people with stroke say that lack of time and fatigue are barriers to exercise. It is possible to target several components of fitness with one type of exercise.
'Reactive balance training' (RBT) is a type of exercise that improves control of reactions that are needed to prevent a fall after losing balance, and is the only type of exercise with potential to prevent falls in daily life post-stroke. Because RBT involves repeated whole-body movements it may have similar aerobic benefit as other exercises using whole-body movements (eg, brisk walking). Also, leg muscles need to generate a lot of force to make rapid steps in RBT; repeatedly generating this force may help to improve strength.
The purpose of this study is to determine if RBT improves two important components of fitness among people with chronic stroke: aerobic capacity and strength. The investigators expect that the improvements in aerobic capacity and strength after RBT will not be any worse than after an exercise program that specifically targets aerobic fitness and strength. A secondary purpose of this study is to determine the effects of RBT compared to aerobic and strength training on balance control and balance confidence. The investigators expect that RBT will lead to greater improvements in balance control and balance confidence than an aerobic and strength training program.
Detailed description
This is an assessor-blind randomized non-inferiority trial with an internal pilot study. Research activities will take place at the Toronto Rehabilitation Institute and the University of Toronto. For the internal pilot study, we will initially recruit 20 participants with chronic stroke and randomly assign them to one of two groups: 1) RBT, or 2) AST. Cardiorespiratory fitness, lower-extremity strength, balance control, and balance confidence will be measured pre- and post-intervention. We will calculate the final target sample size using the variability observed in this internal pilot. Additionally, a Trial Steering Committee will determine the criteria for the progression from the internal pilot to the main study, and will decide on the continuation of the internal pilot with or without modifications based on those pre-defined criteria (e.g., criteria based on feasibility or preliminary evidence of effect of the interventions from examination of effect sizes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reactive balance training | Experimental | Other: Reactive balance training |
| Aerobic and strength training | Active comparator | Other: Aerobic and strength training (AST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community-dwelling adults with chronic stroke (>6 months post-stroke).
- Able to stand independently without upper-limb support for >30 seconds.
- Able to tolerate at least 10 postural perturbations while wearing a safety harness.
Key exclusion criteria (12 listed)
- >2.1m tall and/or weighing >150kg (limits of the safety harness system).
- Other neurological condition that could affect balance control (e.g., Parkinson's disease).
- Lower extremity amputation.
- Cognitive, language or communication impairments affecting understanding instructions.
- Recent (last 6 months) significant illness, injury or surgery.
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 |
|---|---|---|
| Reactive balance trainingA variety of tasks will be included to induce external or internal perturbations. External perturbations will be caused by forces outside participants' control (e.g. a push or pull from the physiotherapist). Internal perturbations are when the participant fails to control the centre of mass-base of support relationship during voluntary movement; e.g., 'agility' tasks such as kicking a soccer ball. Each session will include a five-minute warm-up, at least 60 perturbations, and a five-minute cool-down. The difficulty of the task will be set such that participants will 'fail' to recover balance ~50% of the time; 'failure' is defined as use of an upper extremity response, use of external assistance (i.e. from the overhead harness or physiotherapist), or taking more than 2 steps to regain stability. Training tasks will progressed by increasing the perturbation magnitude, including cognitive or movement tasks, or imposing sensory or environmental challenges (e.g. eyes closed, obstacles). | Other | Reactive balance training |
| Aerobic and strength training (AST)AST sessions will consist of 30 minutes of aerobic and 30 minutes of strength training. Aerobic training: Aerobic training will be done using treadmill walking or combination of modalities (e.g. cycling or recumbent stepping) for those unable to maintain the target heart rate with walking. The heart rate that occurred at the ventilatory threshold (V̇O2VT) during the cardiopulmonary exercise test will be used to prescribe intensity. In the absence of a discernible V̇O2VT a combination of the following will be used: 60-80% of heart rate reserve, peak oxygen uptake, and rating of perceived exertion of 11-16 (Borg 6-20 scale). Prescriptions will be initially progressed by increasing duration to ≥20 minutes and then increasing intensity to target heart rate. Resistance training: Participants will be prescribed 1-2 sets of 8 exercises per session (squat, heel raise, ankle dorsiflexion, knee extension and flexion, abdominal curl-up, wall push up, bicep curl), at 70% of 1 repetition maximum. | Other | Aerobic and strength training |
Primary outcome
Aerobic capacity
Time frame: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
A symptom-limited cardiopulmonary exercise test (CPET) will be performed. The CPET will be medically supervised. It will be conducted on the same modality on subsequent assessments and at the same time of day as the supervised exercise classes to minimize effects of heart rate altering medication on exercise prescription. Resistance will be increased every minute until either the patient indicates that he/she would like to stop or abnormalities appear that necessitate discontinuing the test. Breath-by-breath gas samples will be collected via calibrated metabolic cart to determine V̇O2peak and V̇O2VT.
Lower extremity strength
Time frame: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Peak isokinetic torque will be measured using a isokinetic dynamometer. Participants will be seated in the chair (hips at approximately 90 degrees) with the axis of rotation of the dynamometer aligned to the femoral condyles. Shoulder straps will secure the torso and a thigh strap over the active leg will minimize compensatory movements during testing. The inactive leg will be positioned at 90 degrees knee flexion and held in place with a padded bar below the seat. Peak isokinetic muscle torque at a speed of 60 degrees/s will be assessed. Two to three warm-up contractions will be performed at ~50-75% of perceived maximum effort. This will be followed by 5 maximal efforts to obtain peak torque. A one-minute rest will be given between trials to minimize fatigue. The highest torque achieved among the three maximal trials will be used as the peak isokinetic torque. The task will be performed for both legs.
7 secondary outcomes
Berg balance scale
Time frame: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Mini-Balance Evaluation Systems Test
Time frame: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Six-minute walk test
Time frame: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Activities-specific Balance Confidence scale
Time frame: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.
Falls in daily life
Time frame: For 12 months post-intervention
Physical Activity Scale for Individuals with Physical Disabilities
Time frame: 4 months, 8 months, and 12 months post-intervention
Subjective Index of Physical and Social Outcome
Time frame: 4 months, 8 months, and 12 months post-intervention
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 30121600Mansfield A, Aqui A, Danells CJ, Knorr S, Centen A, DePaul VG, Schinkel-Ivy A, Brooks D, Inness EL, Mochizuki G. Does perturbation-based balance training prevent falls among individuals with chronic stroke? A randomised controlled trial. BMJ Open. 2018 Aug 17;8(8):e021510. doi: 10.1136/bmjopen-2018-021510.
- Background: PubMed 29600726Marzolini S, Brooks D, Oh P, Jagroop D, MacIntosh BJ, Anderson ND, Alter D, Corbett D. Aerobic With Resistance Training or Aerobic Training Alone Poststroke: A Secondary Analysis From a Randomized Clinical Trial. Neurorehabil Neural Repair. 2018 Mar;32(3):209-222. doi: 10.1177/1545968318765692. Epub 2018 Mar 30.
- Background: PubMed 27454553Boyne P, Reisman D, Brian M, Barney B, Franke A, Carl D, Khoury J, Dunning K. Ventilatory threshold may be a more specific measure of aerobic capacity than peak oxygen consumption rate in persons with stroke. Top Stroke Rehabil. 2017 Mar;24(2):149-157. doi: 10.1080/10749357.2016.1209831. Epub 2016 Jul 25.
- Background: PubMed 16119407Flansbjer UB, Holmback AM, Downham D, Lexell J. What change in isokinetic knee muscle strength can be detected in men and women with hemiparesis after stroke? Clin Rehabil. 2005 Aug;19(5):514-22. doi: 10.1191/0269215505cr854oa.
- Derived from this study: PubMed 32606059Barzideh A, Marzolini S, Danells C, Jagroop D, Huntley AH, Inness EL, Mathur S, Mochizuki G, Oh P, Mansfield A. Effect of reactive balance training on physical fitness poststroke: study protocol for a randomised non-inferiority trial. BMJ Open. 2020 Jun 30;10(6):e035740. doi: 10.1136/bmjopen-2019-035740.
- Individual participant dataSharing planned: No
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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.
Avril Mansfield, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive balance training and Aerobic and strength training (AST) in people with CVA (Cerebrovascular Accident), run by Toronto Rehabilitation Institute 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 9 Sep 2025. 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 was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
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?
Aerobic capacity (time frame: Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention.). 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?
On the ClinicalTrials.gov record for NCT04042961, which also lists 5 linked publications.
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 9 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.