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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Unknown status

CT.gov ID

NCT02031757

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disorders Peripheral Nervous System Diseases Musculoskeletal Diseases Joint Diseases	Other: perturbation training Other: balance exercises	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.