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Effectiveness of Controlled-perturbation Gait Training on Gait Rehabilitation and Fear of Falling in Individuals With Gait Impairments

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ClinicalTrials.gov Identifier: NCT02031757
Recruitment Status : Unknown
Verified October 2013 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2014
Last Update Posted : April 5, 2016
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

Gait dysfunction often occurs following stroke, neurological or musculoskeletal disease, injury and surgery. One of the consequences of such deficit is an increased risk of fall and injury. A gait training regime that incorporates controlled perturbation has been found to reduce falls in elderly population but the effectiveness of such training has yet to be studied.

The aim of this study is to evaluate the effectiveness of specific controlled dynamic perturbation training, during gait, on gait rehabilitation, fear of falling and falling with gait impaired individuals. Perturbation will be performed using a specifically designed system that provides small, controlled and unpredictable perturbations during treadmill walking.

Condition or disease Intervention/treatment
Cerebrovascular Disorders Peripheral Nervous System Diseases Musculoskeletal Diseases Joint Diseases Other: perturbation training Other: balance exercises

Detailed Description:
A total of 100 adults with gait dysfunction will be enrolled, evaluated and trained. They will be randomly assigned to two groups: perturbation training group and balance exercises group. Both groups will receive standard physiotherapy treatments. No gender based differences are expected so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 12 occasions over a period of 10-12 weeks (15 minutes, 2-3 times/week) in addition to standard care physiotherapy. Gait, balance function and fear of falling will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit of training.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Controlled-perturbation Gait Training on Gait Rehabilitation and Fear of Falling in Individuals With Gait Impairments.
Study Start Date : December 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: perturbation training
Standard physiotherapy augmented with perturbation training (BaMPer system).
Other: perturbation training
training utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking.
Active Comparator: balance exercise
standard physiotherapy augmented with balance exercises.
Other: balance exercises
specific exercises regularly used in rehabilitation aiming to improve balance

Primary Outcome Measures :
  1. short Falls Efficacy Scale International (FES-I) [ Time Frame: up to 6 months ]
    a short, easy to administer tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity

Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: UP TO 6 MONTHS ]
    The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks

  2. BalanceMaster LIMITS OF STABILITY (LOS) test [ Time Frame: up to 6 months ]
    The LOS quantifies the maximum distance a person can intentionally displace their Center of Gravity without losing balance, stepping, or reaching for assistance.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ambulatory capability of over 2 in Functional Ambulation Classification .
  • No less then 4 weeks following surgery.
  • preserved mental capacity.

Exclusion Criteria:

  • less then 4 weeks following surgery or injury.
  • Symptomatic orthostatic hypotension, respiratory or cardiovascular, disorders that may interfere with participation in the perturbation program.

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): NCT02031757

Contact: Hadas Lemberg, PHD 97226776095 LHADAS@HADASSAH.ORG.IL

Hadassah Medical Organization, Not yet recruiting
Jerusalem,, Israel
Contact: Arik Tzukert,, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg,, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: ISABELLA SCHWARTZ, md         
Sponsors and Collaborators
Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02031757     History of Changes
Other Study ID Numbers: GaitPert-HMO-CTIL
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: October 2013

Keywords provided by Hadassah Medical Organization:
Balance control
Balance reactions

Additional relevant MeSH terms:
Nervous System Diseases
Joint Diseases
Musculoskeletal Diseases
Cerebrovascular Disorders
Peripheral Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neuromuscular Diseases