Clinical trial NCT02215590: Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims
Official title: Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Postural balance
Motor Learning and Motor Control
Community integration
Quality of life
Functional ambulation
Lead sponsor: Reuth Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
timeFrame: 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:
measure: 10 Meter walk Test (10MWT)
timeFrame: Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Recruitment stage
measure: fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed
timeFrame: Base line brain activity; change after treatment; and change after 6 months with no interventions
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Reuth Rehabilitation Hospital
Study officials:
affiliation: The Laboratory for Rehabilitation and Motor Control of Walking Faculty of Health Sciences at Ben-Gurion University of the Negev Israel
name: Simona Bar-Haim, PhD; PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Reuth Rehabilitation Hospital Tel-Aviv Israel.
name: Jean-Jacques Vatine, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.