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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cerebrovascular Disorders; Joint Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases
• Intervention / Treatment: 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
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadas Lemberg, PHD; Phone Number: 97226776095; Email: LHADAS@HADASSAH.ORG.IL

Study Locations

• Israel
  • Jerusalem,, Israel
    • Hadassah Medical Organization,
    • Principal Investigator: ISABELLA SCHWARTZ, md
    • Contact: Arik Tzukert,, DMD; Phone Number: 00 972 2 6776095; Email: arik@hadassah.org.il
    • Contact: Hadas Lemberg,, PhD; Phone Number: 00 972 2 6777572; Email: lhadas@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	UP TO 6 MONTHS
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.	up to 6 months

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Aging; Balance control; Perturbation; Balance reactions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: GaitPert-HMO-CTIL