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

NCT02215590 | Completed DMC

• 1 other identifier: 2014-9
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.Test the walking functionality of people following Acquired brain injury (ABI)
2. 2.Suggesting a new treatment for their walking impairments
3. 3.Follow-up of motor learning ability and balance after intervention within this population

Conditions

Acquired Brain Injury

Keywords

Postural balance; Motor Learning and Motor Control; Community integration; Quality of life; Functional ambulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 10 Meter walk Test (10MWT)

  Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months

• Montreal Cognitive Assessment (MoCA)

  Recruitment stage

• fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed

  Base line brain activity; change after treatment; and change after 6 months with no interventions

Study Arms (1)

Re-Step

EXPERIMENTAL

The system consists of a pair of special shoes which 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

Interventions

Re-Step DEVICE

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.

Also known as: Step of Mind's Re-Step System shoes

Re-Step

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, 6772829, Israel

Location

Related Publications (1)

• Joubran K, Bar-Haim S, Shmuelof L. Dynamic balance recovery in chronic acquired brain injury participants following a perturbation training. Int J Rehabil Res. 2021 Dec 1;44(4):350-357. doi: 10.1097/MRR.0000000000000485.

  PMID: 34739006 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Jean-Jacques Vatine, Dr.

  Reuth Rehabilitation Hospital Tel-Aviv Israel.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2014
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

IL (1)