StrokeEarly Phase 1NCT02619175
Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
A Early Phase 1 study testing Stroke Subjects Perturbation-Based Balance Training and Stroke Subjects Weight Shifting and Gait training in people with Stroke, run by Nachum Soroker, MD at 1 site in Israel.
Trial summary
aim: To examine the effect of a perturbation-based balance training on balance reaction characteristics in post stroke individuals. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke Subjects Perturbation-Based Balance Training and Stroke Subjects Weight Shifting and Gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to Mar 2019
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For measurements taken while standing, post stroke subjects will meet the criteria of being able to stand independently or with supervision for at least 2 minutes.
- For measurements taken while walking, post stroke subjects will meet the criteria of being able to walk for at least 10 meter with supervision/independently without walking aids.
- 3 weeks-6 months post stroke (hemorrhage/infarct)
- First stroke
- Age 25-75 years
- Able to understand research instructions
- Stable clinical/metabolic state
Who cannot join
- - A history of neurological diseases amongst peripheral neuropathy
- Significant skeletal system diseases, such as severe osteoporosis
- Uncontrolled atrial fibrillation
- Unstable ischemic heart disease
- Significant visual deficiency
- Dizziness
- Pregnancy
- Body weight above 135 kg
Trial locations and contacts
1 site in 1 country.
About this study
aim: To examine the effect of a perturbation-based balance training on balance reaction characteristics in post stroke individuals.
Read the detailed description
60 stroke subjects from the neurology rehabilitation unit at Loewenstein hospital will be randomly allocated to one of two groups: 1) perturbations based balance training 2) weight shifting and gait training without external perturbations (control).
Group 1 - Perturbations based balance training Subjects will complete a perturbation based balance training while standing and walking on the BalanceTutor (MediTouch). Perturbation level will be individually adjusted and progressed according to subject's abilities. Progression occurs by increasing perturbation level (increase distance, velocity and acceleration). At each practiced level subjects will be exposed to random right/left/forward/backward unannounced platform translations while standing and to right/left perturbations (in defined events in gait cycle) while walking. In order to examine adaptation to repeated perturbations, kinematic data will be collected in the first session.
Group 2 - Weight shifting and gait training Subjects will complete a balance training program that includes voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. Weight shifting toward a target will be adjusted and progressed according to subject's abilities. Progression in difficulty level will occur by increasing the distance to target without changing the base of support. At each practiced level weight shifting will be conducted to right/left/forward/backward directions. In the gait part of the session, subjects will be asked to walk at their preferred treadmill walking speed.
Subjects in both groups will complete 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes and will include practice in standing and walking. Subject's activities will be documented in each session in both groups. Furthermore, in each session subjects will be asked to rate their perceived level of challenge on a 0-10 scale.
Pre- and post-intervention measurements will be conducted. A follow-up measurement will be conducted 3-6 weeks post intervention.
The following measurements will be administered:
1)Compensatory balance reaction kinematic measurement:
Compensatory balance reactions will be measured using the BalanceTutor (MediTouch). The BalanceTutor is a mechatronic device consisting of a computerized treadmill with a horizontal movable platform and an operator station. Measurements will be taken in two conditions:
Standing. Subjects will be instructed to stand and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled. The increases in platform translation will be adjusted by the examiner to the subject's ability to recover from perturbations. Participants will be asked to respond in a "natural" manner to perturbations.
Walking. Subjects will be instructed to walk comfortably (self-paced) on the treadmill, and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled and will be adjusted by the examiner to the subject's ability to recover from perturbations. Compensatory balance reaction characteristics (reaction time, swing time, compensatory step time, step length etc.) will be collected through a three-dimensional motion analysis system. During examination subjects will wear a loose safety harness that will prevent a fall and yet allow the execution of balance recovery reactions.
In addition, clinical measures will be used: Berg Balance Scale, 6 minute walk test, 10 meter walk test, the Fugl-Meyer test for motor recovery after stroke and the ABC (Activities-specific Balance Confidence) scale. Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics).
- Conditions
- Stroke
- Being tested
- Stroke Subjects Perturbation-Based Balance Training, Stroke Subjects Weight Shifting and Gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke Subjects Perturbation-Based Balance TrainingDevice
Stroke Subjects Weight Shifting and Gait trainingDevice
| Study group | Role | What they receive |
|---|---|---|
| Perturbation-based balance training | Experimental | perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).
10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. Receives: Device: Stroke Subjects Perturbation-Based Balance Training |
| Weight shifting and gait training | Active comparator | Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.
10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. Receives: Device: Stroke Subjects Weight Shifting and Gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Compensatory Step Execution Time
Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system.
Step execution time in response to surface translations toward the non-paretic side.
Measured: 1-5 days before the first session of intervention and 1-5 days after the last session of intervention.
Change in Compensatory Step Velocity
will be calculated from step length and step swing time data, using a 3D motion analysis system.
Step velocity in response to surface translations toward the non-paretic side.
Measured: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Secondary outcomes (3)
Change in Berg Balance Scale Score
A 14-item objective measure (ordinal scale) designed to assess static balance and fall risk.
Minimus score =0, Maximal score=56. Higher values represent a better outcome.
Measured: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Change in Fall Threshold
The perturbation level at which the subject lost balance and fell into the safety harness. Score on a scale (1-7). Each unit represents the perturbation intensity where the subject was unable to recover balance and fell into harness system. Higher values represent a better outcome.
Measured: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Change in Activities-specific Balance Confidence (ABC) Scale
A self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Score on a scale (0-100). Higher values represent a better outcome.
Measured: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nachum Soroker, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor-investigator, Nachum Soroker, MD, Loewenstein Hospital
- Investigators
- nachum Soroker, Principal investigator, Loewenstein rehabilitation hospital, Raanana, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619175
- Sponsor's protocol ID
- loe150021ctil
- Status last verified
- Sep 2019
- First submitted
- 23 Nov 2015
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Handelzalts S, Steinberg-Henn F, Farquhar J, Shkedy Rabani A, Levy S, Riemer R, Soroker N, Melzer I. Temporal But Not Spatial Gait Parameters Associated With Lower Balance Capacity in Moderate-High Functioning Persons With Stroke. J Neurol Phys Ther. 2021 Oct 1;45(4):301-309. doi: 10.1097/NPT.0000000000000368.
PubMed 34369447
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
- ClinicalTrials.gov ID
- NCT02619175
- Acronym / sponsor ID
- loe150021ctil
- Conditions
- Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nachum Soroker, MDUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Nov 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
aim: To examine the effect of a perturbation-based balance training on balance reaction characteristics in post stroke individuals.
Detailed description
60 stroke subjects from the neurology rehabilitation unit at Loewenstein hospital will be randomly allocated to one of two groups: 1) perturbations based balance training 2) weight shifting and gait training without external perturbations (control).
Group 1 - Perturbations based balance training Subjects will complete a perturbation based balance training while standing and walking on the BalanceTutor (MediTouch). Perturbation level will be individually adjusted and progressed according to subject's abilities. Progression occurs by increasing perturbation level (increase distance, velocity and acceleration). At each practiced level subjects will be exposed to random right/left/forward/backward unannounced platform translations while standing and to right/left perturbations (in defined events in gait cycle) while walking. In order to examine adaptation to repeated perturbations, kinematic data will be collected in the first session.
Group 2 - Weight shifting and gait training Subjects will complete a balance training program that includes voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. Weight shifting toward a target will be adjusted and progressed according to subject's abilities. Progression in difficulty level will occur by increasing the distance to target without changing the base of support. At each practiced level weight shifting will be conducted to right/left/forward/backward directions. In the gait part of the session, subjects will be asked to walk at their preferred treadmill walking speed.
Subjects in both groups will complete 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes and will include practice in standing and walking. Subject's activities will be documented in each session in both groups. Furthermore, in each session subjects will be asked to rate their perceived level of challenge on a 0-10 scale.
Pre- and post-intervention measurements will be conducted. A follow-up measurement will be conducted 3-6 weeks post intervention.
The following measurements will be administered:
1)Compensatory balance reaction kinematic measurement:
Compensatory balance reactions will be measured using the BalanceTutor (MediTouch). The BalanceTutor is a mechatronic device consisting of a computerized treadmill with a horizontal movable platform and an operator station. Measurements will be taken in two conditions:
Standing. Subjects will be instructed to stand and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled. The increases in platform translation will be adjusted by the examiner to the subject's ability to recover from perturbations. Participants will be asked to respond in a "natural" manner to perturbations.
Walking. Subjects will be instructed to walk comfortably (self-paced) on the treadmill, and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled and will be adjusted by the examiner to the subject's ability to recover from perturbations. Compensatory balance reaction characteristics (reaction time, swing time, compensatory step time, step length etc.) will be collected through a three-dimensional motion analysis system. During examination subjects will wear a loose safety harness that will prevent a fall and yet allow the execution of balance recovery reactions.
In addition, clinical measures will be used: Berg Balance Scale, 6 minute walk test, 10 meter walk test, the Fugl-Meyer test for motor recovery after stroke and the ABC (Activities-specific Balance Confidence) scale. Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Perturbation-based balance training | Experimental | Device: Stroke Subjects Perturbation-Based Balance Trainingperturbation-based balance training while standing and walking on the BalanceTutor (MediTouch). 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. |
| Weight shifting and gait training | Active comparator | Device: Stroke Subjects Weight Shifting and Gait trainingBalance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For measurements taken while standing, post stroke subjects will meet the criteria of being able to stand independently or with supervision for at least 2 minutes.
- For measurements taken while walking, post stroke subjects will meet the criteria of being able to walk for at least 10 meter with supervision/independently without walking aids.
- 3 weeks-6 months post stroke (hemorrhage/infarct)
- First stroke
- Age 25-75 years
Key exclusion criteria (8 listed)
- - A history of neurological diseases amongst peripheral neuropathy
- Significant skeletal system diseases, such as severe osteoporosis
- Uncontrolled atrial fibrillation
- Unstable ischemic heart disease
- Significant visual deficiency
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 |
|---|---|---|
| Stroke Subjects Perturbation-Based Balance Training | Device | Perturbation-based balance training |
| Stroke Subjects Weight Shifting and Gait training | Device | Weight shifting and gait training |
Primary outcome
Change in Compensatory Step Execution Time
Time frame: 1-5 days before the first session of intervention and 1-5 days after the last session of intervention.
Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system. Step execution time in response to surface translations toward the non-paretic side.
Change in Compensatory Step Velocity
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
will be calculated from step length and step swing time data, using a 3D motion analysis system. Step velocity in response to surface translations toward the non-paretic side.
3 secondary outcomes
Change in Berg Balance Scale Score
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Change in Fall Threshold
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Change in Activities-specific Balance Confidence (ABC) Scale
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34369447Handelzalts S, Steinberg-Henn F, Farquhar J, Shkedy Rabani A, Levy S, Riemer R, Soroker N, Melzer I. Temporal But Not Spatial Gait Parameters Associated With Lower Balance Capacity in Moderate-High Functioning Persons With Stroke. J Neurol Phys Ther. 2021 Oct 1;45(4):301-309. doi: 10.1097/NPT.0000000000000368.
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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.
nachum Soroker principal investigator
Loewenstein rehabilitation hospital, Raanana, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stroke Subjects Perturbation-Based Balance Training and Stroke Subjects Weight Shifting and Gait training in people with Stroke, run by Nachum Soroker, MD at 1 site in Israel.
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 7 inclusion and 8 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 30 Sep 2019. 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 Israel. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Compensatory Step Execution Time (time frame: 1-5 days before the first session of intervention and 1-5 days after the last session of 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 NCT02619175, which also lists 1 linked publication.
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 30 Sep 2019.