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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT02031757
First received: January 8, 2014
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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 Intervention
Cerebrovascular Disorders
Peripheral Nervous System Diseases
Musculoskeletal Diseases
Joint Diseases
Other: perturbation training
Other: balance exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • short Falls Efficacy Scale International (FES-I) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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:
  • Berg Balance Scale [ Time Frame: UP TO 6 MONTHS ] [ Designated as safety issue: No ]
    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

  • BalanceMaster LIMITS OF STABILITY (LOS) test [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    The LOS quantifies the maximum distance a person can intentionally displace their Center of Gravity without losing balance, stepping, or reaching for assistance.


Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031757

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

Locations
Israel
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
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02031757     History of Changes
Other Study ID Numbers: GaitPert
Study First Received: January 8, 2014
Last Updated: January 8, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Balance control
Aging
Balance reactions
Perturbation

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

ClinicalTrials.gov processed this record on September 14, 2014