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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

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02215590
Study type Interventional
Source Reuth Rehabilitation Hospital
Contact
Status Completed
Phase N/A
Start date September 2014
Completion date May 30, 2018
View Details
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