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

Primary Purpose

Cerebrovascular Disorders, Peripheral Nervous System Diseases, Musculoskeletal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
perturbation training
balance exercises
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Disorders focused on measuring Balance control, Aging, Balance reactions, Perturbation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

perturbation training

balance exercise

Arm Description

Standard physiotherapy augmented with perturbation training (BaMPer system).

standard physiotherapy augmented with balance exercises.

Outcomes

Primary Outcome Measures

short Falls Efficacy Scale International (FES-I)
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
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
The LOS quantifies the maximum distance a person can intentionally displace their Center of Gravity without losing balance, stepping, or reaching for assistance.

Full Information

First Posted
January 8, 2014
Last Updated
April 4, 2016
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02031757
Brief Title
Effectiveness of Controlled-perturbation Gait Training on Gait Rehabilitation and Fear of Falling in Individuals With Gait Impairments
Official Title
The Effectiveness of Controlled-perturbation Gait Training on Gait Rehabilitation and Fear of Falling in Individuals With Gait Impairments.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Peripheral Nervous System Diseases, Musculoskeletal Diseases, Joint Diseases
Keywords
Balance control, Aging, Balance reactions, Perturbation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
perturbation training
Arm Type
Experimental
Arm Description
Standard physiotherapy augmented with perturbation training (BaMPer system).
Arm Title
balance exercise
Arm Type
Active Comparator
Arm Description
standard physiotherapy augmented with balance exercises.
Intervention Type
Other
Intervention Name(s)
perturbation training
Intervention Description
training utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking.
Intervention Type
Other
Intervention Name(s)
balance exercises
Intervention Description
specific exercises regularly used in rehabilitation aiming to improve balance
Primary Outcome Measure Information:
Title
short Falls Efficacy Scale International (FES-I)
Description
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
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
UP TO 6 MONTHS
Title
BalanceMaster LIMITS OF STABILITY (LOS) test
Description
The LOS quantifies the maximum distance a person can intentionally displace their Center of Gravity without losing balance, stepping, or reaching for assistance.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PHD
Phone
97226776095
Email
LHADAS@HADASSAH.ORG.IL
Facility Information:
Facility Name
Hadassah Medical Organization,
City
Jerusalem,
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert,, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg,, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
ISABELLA SCHWARTZ, md

12. IPD Sharing Statement

Learn more about this trial

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

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