Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02215590
Other study ID # 2014-9
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date May 30, 2018

Study information

Verified date March 2021
Source Reuth Rehabilitation Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - At least one year after the Acquired brain injury. - Age 18 to 80 years - Independent walking ability for at least 10 meters - Patients who permanently use medications that have not been changed during the past month and with no further changes expected during the research - At least 19 points on 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 a 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Israel Reuth Rehabilitation Hospital Tel-Aviv

Sponsors (1)

Lead Sponsor Collaborator
Reuth Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed CB&M was designed to evaluate balance and mobility in patients who, although ambulatory, have balance impairments that reduce their full engagement in community living. 13 items of dynamic balance are graded 0-5 by a physiotherapist. The CB&M is a reliable and valid clinical outcome measure for evaluating change in ability in the higher functioning ambulatory patients with TBI. Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention
Secondary 10 Meter walk Test (10MWT) 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. Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months
Secondary Montreal Cognitive Assessment (MoCA) 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 places the individual on a scale of cognitive function.
The MoCA test has a high sensitivity for detecting cognitive dysfunction.
Recruitment stage
Secondary fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed 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. Base line brain activity; change after treatment; and change after 6 months with no interventions
See also
  Status Clinical Trial Phase
Completed NCT03911752 - Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Not yet recruiting NCT05863897 - e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury N/A
Recruiting NCT05309005 - Virtual Reality and Social Cognition After Acquired Brain Injury
Recruiting NCT05443542 - VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI N/A
Recruiting NCT04586842 - Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury N/A
Completed NCT03328221 - Physical Activity on Heart Rate Variability in Patients With Severe Acquired Brain Injury
Active, not recruiting NCT05734183 - Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness N/A
Active, not recruiting NCT05729165 - Local Vibration in Patients With Severe Acquired Brain Injury N/A
Recruiting NCT05440682 - Connectivity in Cranioplasty N/A
Completed NCT04206475 - Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj. N/A
Recruiting NCT02495558 - Cough Assessment in Patients With Severe Acquired Brain Injury N/A
Completed NCT03989388 - Occupational Self-Analysis Programme N/A
Terminated NCT01974635 - Proprioception Testing in Persons With Sensorimotor Impairment N/A
Not yet recruiting NCT01451242 - The Reliability of Heart Rate Variability Among Patients With Brain Injury as Measured by POLAR RC810XE Compared to HOLTER N/A
Completed NCT05052905 - VR-based Remote Rehabilitation for Pediatric ABI N/A
Recruiting NCT06130735 - Impact of Intensive Computerized Cognitive Training N/A
Recruiting NCT04328857 - Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing N/A
Completed NCT04499092 - COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery N/A
Completed NCT03674398 - Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology N/A