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

Not Applicable

• Conditions: Musculoskeletal Diseases; Joint Diseases; Peripheral Nervous System Diseases; Cerebrovascular Disorders
• Interventions: Other: balance exercises; Other: perturbation training

• Registration Number: NCT02031757
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2013-10
• Study Start: 2013-12
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balance exercise	balance exercises	standard physiotherapy augmented with balance exercises.
perturbation training	perturbation training	Standard physiotherapy augmented with perturbation training (BaMPer system).

Primary Outcome Measures

Name	Time	Method
short Falls Efficacy Scale International (FES-I)	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

Name	Time	Method
Berg Balance Scale	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
BalanceMaster LIMITS OF STABILITY (LOS) test	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.

Trial Locations

Locations (1)

Hadassah Medical Organization,; 🇮🇱 Jerusalem,, Israel