Acquired Brain InjuryNCT02215590
Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims
A study testing Re-Step in people with Acquired Brain Injury, run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial summary
The purpose of this study is to: 1. Test the walking functionality of people following Acquired brain injury (ABI) 2. Suggesting a new treatment for their walking impairments 3. Follow-up of motor learning ability and balance after intervention within this population The investigators intend to target dynamic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Re-Step
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to 30 May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one year after the Acquired brain injury.
- Age 18 to 80 years
- Independent walking ability for at least 10 meters
- Patients who permanently use medications that have not been changed during the past month and with no further changes expected during the research
- At least 19 points on the MoCA test
Who cannot join
- Presence of degenerative neurological disability that is not secondary to the acquired brain injury
- Other disabilities such as - severe back pain, radical active lumbosacral radicular pain, leg muscle pain, peripheral neuropathy, post-polio syndrome, rheumatic illnesses, previous orthopedic disabilities preceding or at the time of the injury that could affect the ability and pattern of walking, depression, and other neurotic syndromes including post-traumatic depression and post-traumatic stress disorder (PTSD) at a medium level or higher, chronic alcoholism and use of drugs.
- Unstable state of health such as heart disease, respiratory insufficiency, peripheral vascular disease, acquired brain injury that has impaired walking ability
- Inability to persevere and cooperate in the series of tests and the follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial
The purpose of this study is to:
- Test the walking functionality of people following Acquired brain injury (ABI)
- Suggesting a new treatment for their walking impairments
- Follow-up of motor learning ability and balance after intervention within this population
The investigators intend to target dynamic stability and gait after ABI, in a group of individuals with ABI who have persistent balance and mobility deficits despite being able to walk independently and having high scores on standard clinical balance measures.
Interventions: Training with Re-Step system shoes.
In this study there is no control group.
Read the detailed description
Study design:
Type of research: Prospective, exploratory, clinical, interventional trial
Specific objectives are:
To explore the efficacy of Re-step rehabilitation technology to improve dynamic balance in the gait of people after Acquired Brain Injury (ABI).
The investigators suggest a new technology of intervention that will induce unexpected changes of underfoot slopes, with Re-Step shoes, during walking and will force the central nervous system (CNS) to react and solve walking problems in real-time.
The investigators propose that the new approach will have a significant motor function improvement on balance in gait, transferred to real environmental settings and be retained for long periods of time.
Research methods:
Subjects:
A total of 40 subjects of ABI victims will be studied in one treatment group-Re-Step shoes walking training
Time flow protocol:
Participants will be approached using a database of hospitalized patients of Reuth Rehabilitation Hospital (Tel-Aviv, Israel) and through a call for participation placed in a newspaper.
Subjects will be recruited according to inclusion/exclusion criteria, after medical examination and given consent of participation.
Tests and measures (see outcome measures) will be applied to measure changes:
- T1 - before starting the intervention to form a baseline
- T2 - after 20 sessions of intensive treatments 60 min each, 2 sessions a week.
- T3 - 6 months after T2, a period of normal daily schedule of subjects, with no interventions, to examine for retainment of training results.
The treatments will start in a week from T1; the T2 will be performed in a week after training was completed; T3 will be performed 6 months (take or leave 2 weeks) after T2.
- Conditions
- Acquired Brain Injury
- Being tested
- Re-Step
- Keywords
- Postural balance, Motor Learning and Motor Control, Community integration, Quality of life, Functional ambulation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-StepDevice
Also called Step of Mind's Re-Step System shoes
Research Group:
Each session begins with a warm-up exercise, muscle stretching, and strengthening exercises: duration 10 minutes.
Afterwards, walking exercises for 40 minutes with Re-Step according to a program individually tailored and progressing with the training. Progress is shown by an increased range of tilting of the shoe and speed of changes, according to the individual ability of each patient.
At the end of the session 10 min of cool-down exercises
22 training sessions of 60 minutes each, twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Re-Step | Experimental | The system consists of a pair of special shoes which sole height and angles change in a specific given order, thereby facilitating motor learning and problem solving in real time.
This unpredictable change will introduce a situation of necessary adaptation to keep balance. Receives: Device: Re-Step |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
CB\&M was designed to evaluate balance and mobility in patients who, although ambulatory, have balance impairments that reduce their full engagement in community living. 13 items of dynamic balance are graded 0-5 by a physiotherapist. The CB\&M is a reliable and valid clinical outcome measure for evaluating change in ability in the higher functioning ambulatory patients with TBI.
Measured: Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention
Secondary outcomes (3)
10 Meter walk Test (10MWT)
Assesses walking speed in meters per second over a short duration. The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.
Measured: Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months
Montreal Cognitive Assessment (MoCA)
Widely used method for assessing cognitive mental status both in clinical practice and in research.
It is a brief, standardized method to grade patients' cognitive mental status. It assesses orientation, attention, immediate and short-term recall, language, and the ability to follow simple verbal and written commands. It provides a total score that places the individual on a scale of cognitive function.
The MoCA test has a high sensitivity for detecting cognitive dysfunction.
Measured: Recruitment stage
fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed
Functional magnetic resonance imaging or functional MRI (fMRI) is a functional neuroimaging procedure using MRI technology that measures brain activity by detecting associated changes in blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases.
Measured: Base line brain activity; change after treatment; and change after 6 months with no interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Bar-Haim, PhD; PT, Principal investigator, The Laboratory for Rehabilitation and Motor Control of Walking Faculty of Health Sciences at Ben-Gurion University of the Negev IsraelJean-Jacques Vatine, Dr., Study director, Reuth Rehabilitation Hospital Tel-Aviv Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215590
- Sponsor's protocol ID
- 2014-9
- Status last verified
- Mar 2021
- First submitted
- 24 Jul 2014
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joubran K, Bar-Haim S, Shmuelof L. Dynamic balance recovery in chronic acquired brain injury participants following a perturbation training. Int J Rehabil Res. 2021 Dec 1;44(4):350-357. doi: 10.1097/MRR.0000000000000485.
PubMed 34739006
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT02215590
- Acronym / sponsor ID
- 2014-9
- Conditions
- Acquired Brain Injury
- Keywords
- Postural balance, Motor Learning and Motor Control, Community integration, Quality of life, Functional ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 13 Aug 2014 (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.
The purpose of this study is to:
- Test the walking functionality of people following Acquired brain injury (ABI)
- Suggesting a new treatment for their walking impairments
- Follow-up of motor learning ability and balance after intervention within this population
The investigators intend to target dynamic stability and gait after ABI, in a group of individuals with ABI who have persistent balance and mobility deficits despite being able to walk independently and having high scores on standard clinical balance measures.
Interventions: Training with Re-Step system shoes.
In this study there is no control group.
Detailed description
Study design:
Type of research: Prospective, exploratory, clinical, interventional trial
Specific objectives are:
To explore the efficacy of Re-step rehabilitation technology to improve dynamic balance in the gait of people after Acquired Brain Injury (ABI).
The investigators suggest a new technology of intervention that will induce unexpected changes of underfoot slopes, with Re-Step shoes, during walking and will force the central nervous system (CNS) to react and solve walking problems in real-time.
The investigators propose that the new approach will have a significant motor function improvement on balance in gait, transferred to real environmental settings and be retained for long periods of time.
Research methods:
Subjects:
A total of 40 subjects of ABI victims will be studied in one treatment group-Re-Step shoes walking training
Time flow protocol:
Participants will be approached using a database of hospitalized patients of Reuth Rehabilitation Hospital (Tel-Aviv, Israel) and through a call for participation placed in a newspaper.
Subjects will be recruited according to inclusion/exclusion criteria, after medical examination and given consent of participation.
Tests and measures (see outcome measures) will be applied to measure changes:
- T1 - before starting the intervention to form a baseline
- T2 - after 20 sessions of intensive treatments 60 min each, 2 sessions a week.
- T3 - 6 months after T2, a period of normal daily schedule of subjects, with no interventions, to examine for retainment of training results.
The treatments will start in a week from T1; the T2 will be performed in a week after training was completed; T3 will be performed 6 months (take or leave 2 weeks) after T2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Re-Step | Experimental | Device: Re-StepThe system consists of a pair of special shoes which sole height and angles change in a specific given order, thereby facilitating motor learning and problem solving in real time. This unpredictable change will introduce a situation of necessary adaptation to keep balance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least one year after the Acquired brain injury.
- Age 18 to 80 years
- Independent walking ability for at least 10 meters
- Patients who permanently use medications that have not been changed during the past month and with no further changes expected during the research
- At least 19 points on the MoCA test
Key exclusion criteria (4 listed)
- Presence of degenerative neurological disability that is not secondary to the acquired brain injury
- Other disabilities such as - severe back pain, radical active lumbosacral radicular pain, leg muscle pain, peripheral neuropathy, post-polio syndrome, rheumatic illnesses, previous orthopedic disabilities preceding or at the time of the injury that could affect the ability and pattern of walking, depression, and other neurotic syndromes including post-traumatic depression and post-traumatic stress disorder (PTSD) at a medium level or higher, chronic alcoholism and use of drugs.
- Unstable state of health such as heart disease, respiratory insufficiency, peripheral vascular disease, acquired brain injury that has impaired walking ability
- Inability to persevere and cooperate in the series of tests and the follow-up
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 |
|---|---|---|
| Re-StepAlso: Step of Mind's Re-Step System shoesResearch Group: Each session begins with a warm-up exercise, muscle stretching, and strengthening exercises: duration 10 minutes. Afterwards, walking exercises for 40 minutes with Re-Step according to a program individually tailored and progressing with the training. Progress is shown by an increased range of tilting of the shoe and speed of changes, according to the individual ability of each patient. At the end of the session 10 min of cool-down exercises 22 training sessions of 60 minutes each, twice a week. | Device | Re-Step |
Primary outcome
Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
Time frame: Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention
CB\&M was designed to evaluate balance and mobility in patients who, although ambulatory, have balance impairments that reduce their full engagement in community living. 13 items of dynamic balance are graded 0-5 by a physiotherapist. The CB\&M is a reliable and valid clinical outcome measure for evaluating change in ability in the higher functioning ambulatory patients with TBI.
3 secondary outcomes
10 Meter walk Test (10MWT)
Time frame: Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months
Montreal Cognitive Assessment (MoCA)
Time frame: Recruitment stage
fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed
Time frame: Base line brain activity; change after treatment; and change after 6 months with no interventions
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 12 Mar 2021.
- Derived from this study: PubMed 34739006Joubran K, Bar-Haim S, Shmuelof L. Dynamic balance recovery in chronic acquired brain injury participants following a perturbation training. Int J Rehabil Res. 2021 Dec 1;44(4):350-357. doi: 10.1097/MRR.0000000000000485.
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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.
Simona Bar-Haim, PhD; PT principal investigator
The Laboratory for Rehabilitation and Motor Control of Walking Faculty of Health Sciences at Ben-Gurion University of the Negev Israel
Jean-Jacques Vatine, Dr. study director
Reuth Rehabilitation Hospital Tel-Aviv Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Step in people with Acquired Brain Injury, run by Reuth Rehabilitation Hospital 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 5 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 12 Mar 2021. 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.
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?
Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed (time frame: Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention). 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 NCT02215590, 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 12 Mar 2021.