Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims
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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Tel-Aviv, Israël, 6772829
- Reuth Rehabilitation Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Re-Step
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. |
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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
Tijdsspanne: 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.
|
Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
10 Meter walk Test (10MWT)
Tijdsspanne: Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months
|
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.
|
Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months
|
|
Montreal Cognitive Assessment (MoCA)
Tijdsspanne: Recruitment stage
|
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. |
Recruitment stage
|
|
fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed
Tijdsspanne: Base line brain activity; change after treatment; and change after 6 months with no interventions
|
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.
|
Base line brain activity; change after treatment; and change after 6 months with no interventions
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Simona Bar-Haim, PhD; PT, The Laboratory for Rehabilitation and Motor Control of Walking Faculty of Health Sciences at Ben-Gurion University of the Negev Israel
- Studie directeur: Jean-Jacques Vatine, Dr., Reuth Rehabilitation Hospital Tel-Aviv Israel.
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2014-9
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .