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

H

Hadassah Medical Center

Status

Unknown

Conditions

Joint Diseases
Peripheral Nervous System Diseases
Musculoskeletal Diseases
Cerebrovascular Disorders

Treatments

Other: balance exercises
Other: perturbation training

Study type

Interventional

Funder types

Other

Identifiers

NCT02031757
GaitPert-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

perturbation training
Experimental group
Description:
Standard physiotherapy augmented with perturbation training (BaMPer system).
Treatment:
Other: perturbation training
balance exercise
Active Comparator group
Description:
standard physiotherapy augmented with balance exercises.
Treatment:
Other: balance exercises

Trial contacts and locations

1

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Central trial contact

Hadas Lemberg, PHD

Data sourced from clinicaltrials.gov

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