Acquired Brain Injury Clinical Trial
Official title:
Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial
NCT number | NCT02215590 |
Other study ID # | 2014-9 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | May 30, 2018 |
Verified date | March 2021 |
Source | Reuth Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 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.
Status | Completed |
Enrollment | 41 |
Est. completion date | May 30, 2018 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Reuth Rehabilitation Hospital | Tel-Aviv |
Lead Sponsor | Collaborator |
---|---|
Reuth Rehabilitation Hospital |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention | |
Secondary | 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. | Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months | |
Secondary | 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. |
Recruitment stage | |
Secondary | 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. | Base line brain activity; change after treatment; and change after 6 months with no interventions |
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