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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215590
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Reuth Rehabilitation Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Acquired Brain Injury Device: Re-Step Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial
Study Start Date : September 2014
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Re-Step

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.

Device: Re-Step

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.

Other Name: Step of Mind's Re-Step System shoes




Primary Outcome Measures :
  1. 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 ]
    The HiMAT is appropriate for assessing people with high-level balance and mobility problems. 13 mobility items of balance and walking are scored by a physiotherapist 0-5 grades, time and distances are measured.


Secondary Outcome Measures :
  1. 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 ]
    CB&M was designed to evaluate balance and mobility in patients who, although ambulatory, have balance impairments which reduce their full engagement in community living. 13 items of dynamic balance are graded 0-5 by physiotherapist. The CB&M is a reliable and valid clinical outcome measure for evaluating change in ability in the higher functioning ambulatory patient with TBI.

  2. 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 ]

    Descriptive system self reported:

    The questions in the questionnaire are of 5 grades:

    "This survey asks for your views about your health. This information will help you keep track of how you feel and how well you are able to do your usual activities."

    The QOLIBRI consists of 6 dimensions: "Cognition", "Self", "Daily life and Autonomy", "Social Relationships", "Emotions "and "Physical Problems".

    The first four scales assess 'satisfaction' and the final two scales 'feeling bothered' with key aspects of life.

    The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.


  3. 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 ]

    The CIQCommunity integration is designed specifically to assess issues affecting patients with TBI.

    A client-centered survey of perceived connections with the community in 4 dimensions (general assimilation, support, occupation and independent living) developed from the words and ideas of individuals with TBI.

    The CIQ was designed to assess community integration in patients living at home.

    Dimension: 1. home integration. 2. social integration. 3. integration in productive activities.

    Total: 15 items. The total CIQ score = Home integration score + social integration score + productivity score


  4. Functional Ambulation Classification (FAC) [ Time Frame: Base line defining mobility ability ]

    Categorizes patients according to basic motor skills necessary for functional ambulation.

    6 levels: I=Nonfunctional; 6=Independent


  5. 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 ]

    Custom-built TREADMILL, with two separate belts and an embedded force plate underneath. Two motors which can work in different speed for each belt, or in locked mode - together.

    Each belt (i.e., each leg) can be controlled independently. The force plate measures biomechanical parameters. all subjects will held onto a front handrail and will wear a ceiling mounted safety harness around the upper chest.


  6. Montreal Cognitive Assessment (MoCA) [ Time Frame: Recruitment stage ]

    Widely used method for assessing cognitive mental status both in clinical practice and in research.

    It is a brief, standardized method to grade patients' cognitive mental status. It assesses orientation, attention, immediate and short-term recall, language, and the ability to follow simple verbal and written commands. It provides a total score that that places the individual on a scale of cognitive function.

    The MoCA places the individual on a scale of cognitive function and has a high sensitivity for detecting cognitive dysfunction


  7. 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 ]
    Functional magnetic resonance imaging or functional MRI (fMRI) is a functional neuroimaging procedure using MRI technology that measures brain activity by detecting associated changes in blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases.

  8. Dynamic gait index (DGI) [ Time Frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months ]
    a clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks.

  9. Four Square Step Test (FSST) [ Time Frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months ]
    Test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards.

  10. 10 Meter walk Test (10MWT) [ Time Frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months ]
    Assesses walking speed in meters per second over a short duration. The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.

  11. Time Up & Go (TUG) [ Time Frame: Measuring at base line; change immedietly after intervention, and changes and retainments of achievments after 6 months ]

    a simple test used to assess a person's mobility and requires both static and dynamic balance.

    The patient sits in the chair with his/her back against the chair back On the command "go", the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down Timing begins at the instruction "go" and stops when the patient is seated The patient should have one practice trial that is not included in the score (Podsiadlo & Richardson, 1991) Patient must use the same assistive device each time he/she is tested to be able to compare scores


  12. 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 ]

    Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.

    16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215590


Locations
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Israel
Reuth Rehabilitation Hospital
Tel-Aviv, Israel, 6772829
Sponsors and Collaborators
Reuth Rehabilitation Hospital
Investigators
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Principal Investigator: Simona Bar-Haim, PhD; PT The Laboratory for Rehabilitation and Motor Control of Walking Faculty of Health Sciences at Ben-Gurion University of the Negev Israel
Study Director: Jean-Jacques Vatine, Dr. Reuth Rehabilitation Hospital Tel-Aviv Israel.

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Responsible Party: Reuth Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02215590    
Other Study ID Numbers: 2014-9
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: December 2015
Keywords provided by Reuth Rehabilitation Hospital:
Postural balance
Motor Learning and Motor Control
Community integration
Quality of life
Functional ambulation
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System