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

NCT ID: NCT02031757

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

perturbation training

Standard physiotherapy augmented with perturbation training (BaMPer system).

Group Type: EXPERIMENTAL

perturbation training

Intervention Type: OTHER

training utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking.

balance exercise

standard physiotherapy augmented with balance exercises.

Group Type: ACTIVE_COMPARATOR

balance exercises

Intervention Type: OTHER

specific exercises regularly used in rehabilitation aiming to improve balance

Interventions

perturbation training

training utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking.

Intervention Type: OTHER

balance exercises

specific exercises regularly used in rehabilitation aiming to improve balance

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Medical Organization,

Jerusalem, , Israel

Countries

Israel

Central Contacts

Hadas Lemberg, PHD

Role: CONTACT

LHADAS@HADASSAH.ORG.IL

97226776095

Facility Contacts

Arik Tzukert,, DMD

Role: primary

arik@hadassah.org.il

00 972 2 6776095

Hadas Lemberg,, PhD

Role: backup

lhadas@hadassah.org.il

00 972 2 6777572

Other Identifiers

GaitPert-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id