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

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

Status Completed

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

• NCT number: NCT02215590
• Study type: Interventional
• Source: Reuth Rehabilitation Hospital
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Completion date: May 30, 2018