NCT02215590

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

Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Reuth Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Brain Injury

Interventions

Type	Name	Description
DEVICE	Re-Step	Research Group: Each session begins with a warm-up exercise, muscle stretching, and strengthening exercises: duration 10 minutes. Afterwards, walking exercises for 40 minutes with Re-Step according to a program individually tailored and progressing with the training. Progress is shown by an increased range of tilting of the shoe and speed of changes, according to the individual ability of each patient. At the end of the session 10 min of cool-down exercises 22 training sessions of 60 minutes each, twice a week.

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2014-08-13
• Last updated: 2021-03-12

Locations

1 site across 1 country: Israel