Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims

Reuth Rehabilitation Hospital

Status: Completed

Conditions: Acquired Brain Injury

Treatments: Device: Re-Step

Study type: Interventional

Funder types: Other

Identifiers

NCT02215590

2014-9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Re-Step

Experimental group

Description:

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.

Treatment:

Device: Re-Step