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Clinical Trials/NCT02031757
NCT02031757
Unknown
N/A

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

Hadassah Medical Organization1 site in 1 country100 target enrollmentDecember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebrovascular Disorders
Sponsor
Hadassah Medical Organization
Enrollment
100
Locations
1
Primary Endpoint
short Falls Efficacy Scale International (FES-I)
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

short Falls Efficacy Scale International (FES-I)

Time Frame: 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 Outcomes

  • Berg Balance Scale(UP TO 6 MONTHS)
  • BalanceMaster LIMITS OF STABILITY (LOS) test(up to 6 months)

Study Sites (1)

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