Re-Step: Dynamic Balance Treatment of Gait for Acquired Brain Injury (ABI) Victims
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional

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.
    

Intervention name(s): Re-Step
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Step of Mind's Re-Step System shoes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postural balance; Motor Learning and Motor Control; Community integration; Quality of life; Functional ambulation