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Clinical Trials/NCT01439451
NCT01439451
Completed
N/A

Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial

Barzilai Medical Center2 sites in 1 country48 target enrollmentAugust 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Accidental Falls
Sponsor
Barzilai Medical Center
Enrollment
48
Locations
2
Primary Endpoint
voluntary and compensatory step execution times in miliseconds
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training.

Detailed Description

A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures 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 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ornit Cohen

IRB Coordinator

Barzilai Medical Center

Eligibility Criteria

Inclusion Criteria

  • Be 70 years or older, male or female
  • Be an independent ambulator (not cane or walker) and provide medical waiver from MD.

Exclusion Criteria

  • Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty
  • Moderate-severe dementia (Mini-Mental Score \< 24).
  • Serious visual impairment
  • Severe peripheral or compression/entrapment neuropathies.
  • Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.
  • Cancer, metastatic or under active treatment.

Outcomes

Primary Outcomes

voluntary and compensatory step execution times in miliseconds

Time Frame: change from baseline to 3 months later

the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds

Secondary Outcomes

  • postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres(Time 1: pre test' and 3 months later time 2: post testing procedure)

Study Sites (2)

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