Overview

This trial is active, not recruiting.

Condition acquired brain injury
Treatment re-step
Sponsor Reuth Medical Center
Start date September 2014
End date December 2017
Trial size 60 participants
Trial identifier NCT02215590, 2014-9

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The system consists of a pair of special shoes whose 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.
re-step Step of Mind's Re-Step System shoes
Research Group: Each session begins with a warm-up exercise, muscle-stretching and strengthening exercises: duration 10 minutes. Afterwards, walking exercises with Re-Step according to a program individually tailored and progressing with the training. Progress is shown by 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 5 min of cool down exercises 20 training sessions of 60 minutes, two/three a week.

Primary Outcomes

Measure
High-level Mobility Assessment Tool (HiMAT); Change from base line after intervention is being assessed
time frame: Measuring mobility and community functionality at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months

Secondary Outcomes

Measure
Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
time frame: Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention
QUALITY OF LIFE FOLLOW BRAIN INJURY (QOLIBRI); Change from base line after intervention is being assessed
time frame: Base line assessing self reported quality of life, change after intervention, and change after 6 months with no intervention
Community Integration Questionnaire (CIQ),self reported; Change from base line after intervention is being assessed
time frame: Base line before interventions of the participant view on self integration in the community, change 6 months after intervention stoped
Functional Ambulation Classification (FAC)
time frame: Base line defining mobility ability
Split-Belt Treadmill; Change from base line after intervention is being assessed
time frame: Baseline measures center of body mass in walking, steps and adaptability to speed of treadmill, chage after intervention and change 6 months after no interventions
Montreal Cognitive Assessment (MoCA)
time frame: Recruitment stage
fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed
time frame: Base line brain activity; change after treatment; and change after 6 months with no interventions
Dynamic gait index (DGI)
time frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months
Four Square Step Test (FSST)
time frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months
10 Meter walk Test (10MWT)
time frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months
Time Up & Go (TUG)
time frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months
The Activities-specific Balance Confidence (ABC) Scale
time frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - At least one year after the Acquired brain injury. - Age 18 to 80 years - Independent walking ability for at least 10 metres - Patients who permanently use medications that have not been changed during the past month and with no further changes expected during the research - Above 20 cognitive ability in 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 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

Additional Information

Official title Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial
Principal investigator Simona Bar-Haim, PhD; PT
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 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 significantly 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 60 subjects of ABI victims will be studied in one treatment group-Re-Step shoes walking training Time flow protocol: Telephone calls to patients of rehabilitation clinics and call for participation in the papers Recruiting subjects according to inclusion/exclusion criteria, after medical examination and consent of subjects Tests and measures (see outcome measures) will be applied to measure changes - TO - before starting the intervention to form a base line - T1 - after 20 sessions of intensive treatments 60 min each, 2-3 sessions a week. For each subject 10-12 weeks of treatment. - T2 - 6 months after T1, a period of normal daily schedule of subjects, of no interventions, to check retaining of training results. For each subject 10-12 weeks of treatment. The treatments will start in a week from T0; the T1 will be performed in a week after training was completed; T2 will be performed 6 months (take or leave 2 weeks) after T1. The recruitment and training of participants will go on according to availability of facilities not more than 24 months.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Reuth Medical Center.