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

Musculoskeletal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02031757
• Other study ID #: GaitPert-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 8, 2014
• Last updated: April 4, 2016
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2013
• Source: Hadassah Medical Organization
• Contact: Hadas Lemberg, PHD
• Phone: 97226776095
• Email: LHADAS[@]HADASSAH.ORG.IL
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Joint Diseases
• Musculoskeletal Diseases
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Other:
• perturbation training
training utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking.
• balance exercises
specific exercises regularly used in rehabilitation aiming to improve balance

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization,	Jerusalem,

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No