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

NCT02031757 | Unknown

• 1 other identifier: GaitPert-HMO-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Balance control; Aging; Balance reactions; Perturbation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Berg Balance Scale

  UP TO 6 MONTHS

• BalanceMaster LIMITS OF STABILITY (LOS) test

  up to 6 months

Study Arms (2)

perturbation training

EXPERIMENTAL

Standard physiotherapy augmented with perturbation training (BaMPer system).

Other: perturbation training

balance exercise

ACTIVE COMPARATOR

standard physiotherapy augmented with balance exercises.

Other: balance exercises

Interventions

perturbation training OTHER

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

perturbation training

balance exercises OTHER

specific exercises regularly used in rehabilitation aiming to improve balance

balance exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory capability of over 2 in Functional Ambulation Classification .
• No less then 4 weeks following surgery.
• preserved mental capacity.

You may not qualify if:

• less then 4 weeks following surgery or injury.
• Symptomatic orthostatic hypotension, respiratory or cardiovascular, disorders that may interfere with participation in the perturbation program.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, Israel

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases

Central Study Contacts

Hadas Lemberg, PHD

CONTACT

97226776095; LHADAS@HADASSAH.ORG.IL

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 5, 2016

Record last verified: 2013-10

Locations

IL (1)