CLINICAL TRIAL

Reactive balance training for Stroke

Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether a type of exercise can improve aerobic capacity and strength in people with stroke.

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About the trial for Stroke

Eligible Conditions
Stroke · CVA (Cerebrovascular Accident)

Treatment Groups

This trial involves 2 different treatments. Reactive Balance Training is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Reactive balance training
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Aerobic and strength training (AST)
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Able to balance and maintain posture while wearing a safety harness. show original
Independent for more than 30 seconds. show original
People who have had a stroke for more than six months and are still living in the community. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 months, 8 months, and 12 months post-intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months, 8 months, and 12 months post-intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 months, 8 months, and 12 months post-intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Reactive balance training will improve 2 primary outcomes and 7 secondary outcomes in patients with Stroke. Measurement will happen over the course of Data will be collected immediately pre- and post-intervention. We will analyse the change in the outcome from pre- to post-intervention..

Berg balance scale
DATA WILL BE COLLECTED IMMEDIATELY PRE- AND POST-INTERVENTION. WE WILL ANALYSE THE CHANGE IN THE OUTCOME FROM PRE- TO POST-INTERVENTION.
Construct: Functional balance Scale range: 0-56 Higher values represent improved outcome
DATA WILL BE COLLECTED IMMEDIATELY PRE- AND POST-INTERVENTION. WE WILL ANALYSE THE CHANGE IN THE OUTCOME FROM PRE- TO POST-INTERVENTION.
Aerobic capacity
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.
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
DATA WILL BE COLLECTED IMMEDIATELY PRE- AND POST-INTERVENTION. WE WILL ANALYSE THE CHANGE IN THE OUTCOME FROM PRE- TO POST-INTERVENTION.
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
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
DATA WILL BE COLLECTED IMMEDIATELY PRE- AND POST-INTERVENTION. WE WILL ANALYSE THE CHANGE IN THE OUTCOME FROM PRE- TO POST-INTERVENTION.
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
DATA WILL BE COLLECTED IMMEDIATELY PRE- AND POST-INTERVENTION. WE WILL ANALYSE THE CHANGE IN THE OUTCOME FROM PRE- TO POST-INTERVENTION.
Construct: balance confidence Scale range: 0-100 Higher values represent improved outcome
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
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.
DATA WILL BE COLLECTED IMMEDIATELY PRE- AND POST-INTERVENTION. WE WILL ANALYSE THE CHANGE IN THE OUTCOME FROM PRE- TO POST-INTERVENTION.
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Who is running the study

Principal Investigator
A. M.
Avril Mansfield, Principal Investigator
Toronto Rehabilitation Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get stroke a year in the United States?

Approximately 1.7 million cases of stroke occur in the U.S. each year. Between 1990 and 2000, the number of people hospitalized with a stroke increased by 35%. Strokes are the leading cause of disability in the elderly.

Anonymous Patient Answer

What are the signs of stroke?

Firmly fitting a new shoe or sock can trigger the sensation of a limb being "dropped", and may be a warning sign for a stroke. A numb 'cold' feeling near the nose or lips could be a sign of a stroke that has affected the brainstem. A 'dancing' feeling in the arm or leg (often known as "pins and needles") may be an indication of a stroke. A loss of balance may be associated with a stroke causing a 'wobbly' gait.

Anonymous Patient Answer

What is stroke?

Cerebrovascular accidents (stroke) are the results of a complicated interrelationship between multiple risk factors, and are most frequently the result of a large vessel occlusion (an embolus or clots), which reduces blood flow and/or pressure in the affected area of the brain. It is often difficult or impossible to cure this type of stroke, because the blood clot or embolus that blocks blood flow typically does more damage than it blocks blood flow. Many stroke patients recover with the help of rehabilitation or medications. In a large proportion of stroke patients, the disease gradually returns and becomes permanent.

Anonymous Patient Answer

What are common treatments for stroke?

After reviewing the literature and examining patterns of prescribing for stroke, the most common treatments for acute stroke are intravenous thrombolysis, mechanical thrombectomy, anticoagulants to prevent a further blockage in the body, and medication for pain.

Anonymous Patient Answer

Can stroke be cured?

Stroke is much less curable than once thought possible. As well as reducing the incidence of stroke by eliminating modifiable risk factors and, in many cases, reducing the severity of the event by treatment with thrombolytic agents or aspirin, pharmacological treatment of stroke does not affect the frequency of death of patients after stroke.

Anonymous Patient Answer

What causes stroke?

Arteriovenous malformations are an extremely rare cause of stroke. The risk of stroke is increased in patients with multiple arteriovenous malformations. Inflammation and infection, which are common causes of stroke, are unlikely to be a factor in arteriovenous malformation-related stroke.

Anonymous Patient Answer

What is reactive balance training?

A comprehensive reactive balance training program produced greater improvement in static stability than did a control program when administered in this clinical setting and demonstrated no additional benefit when added to a progressive resistance training and strength training program for the rehabilitation of poststroke patients.

Anonymous Patient Answer

What is the latest research for stroke?

The current standard for stroke is 60 cc. This is in no way reflective of the actual performance of the engine when a large volume is supplied to the engine. The actual weight displacement of the engine should be considered when assigning load to engine. Further research seems to be needed to determine the optimum stroke. If the stroke is not optimised, there may be a loss of power or over torque. There may be no benefit of reducing weight displacement of the 4stroke engine by 30 cc in this instance. But in other cases an optimised stroke would benefit the engine, as a large, bulky engine would produce the maximum torque with less power.

Anonymous Patient Answer

Have there been any new discoveries for treating stroke?

There appear to be significant advancements in the treatment of stroke, but they tend to be of a cosmetic nature rather than a significant and meaningful contribution to improving the results of treatment. A multidisciplinary approach in which information is shared from the latest research (which is usually conducted in the United Kingdom) is now considered the gold standard. This is the only way that the discoveries from the UK and around the world are incorporated into the clinical practice and research in stroke.

Anonymous Patient Answer

How does reactive balance training work?

Findings from a recent study emphasize the importance of the balance protocol, in which the participant is instructed to respond to the change in the stimulus (footplate), not to the stimulus alone, but to integrate sensory inputs with changes in the body position in the stance phase of gait.

Anonymous Patient Answer

What are the latest developments in reactive balance training for therapeutic use?

The reactive balance training is now in wide use to treat balance in the elderly, and to rehabilitate patients with vestibular dysfunction. However, patients with a decreased reactive balance capacity are not benefited, and they may actually be harmed, due to exercise overload on impaired balance recovery ability. Therefore, to the best of our knowledge, this is the first study indicating the negative effect of rebound-based exercise on balance recovery in patients with vestibular dysfunction.

Anonymous Patient Answer

Who should consider clinical trials for stroke?

The clinical trials are mainly for strokes, where they have proved to be superior and have been accepted as standard treatments, although we should accept that there was insufficient evidence to back these claims, and some of these treatments have been proven ineffective. Given the lack of good quality evidence linking the most effective treatments with their benefit, we should carefully consider any clinical trial on this topic, at least in some areas. More studies are needed in the area of trials for stroke and thrombolysis to prove efficacies, although the need to be cautious and critical is of the essence. At any rate, considering the good quality of some trials, we should not oppose to testing some approaches in order to find possible more efficient and safe treatments.

Anonymous Patient Answer
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