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Clinical Trials/NCT04228159
NCT04228159
Unknown
Not Applicable

The Effectiveness of Perturbation Training With Balance Tutor, Compared to Balance and Strengthening Exercise, on Falls Rate Among Elderly at Risk of Falling

Clalit Health Services3 sites in 1 country250 target enrollmentNovember 25, 2019
ConditionsFall Prevention

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fall Prevention
Sponsor
Clalit Health Services
Enrollment
250
Locations
3
Primary Endpoint
rate of falls and fallers
Last Updated
6 years ago

Overview

Brief Summary

One third of adults over 65 and 50% of adults above 80 years old fall at list once a year. In some cases, falls result in fractures, hospitalization, functional limitations, depression, morbidity and mortality. Strong evidence support exercise training programs for fall prevention, while several studies examined the effect of perturbation training on risk of fall. The aim of this study is to evaluate the effectiveness of a perturbation training program with unexpected perturbation using balance tutor on falls and injuries among elderly at risk of falling, compared to balance and strengthening exercise.

Registry
clinicaltrials.gov
Start Date
November 25, 2019
End Date
May 25, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • at least one fall during the last 12 months; age 65-85; mini-mental state examination score 24 and above allowing cognitive ability to understand simple instructions ; Time Up and Go (TUG), assessing balance, walking ability and fall risk, scored 13 and above ; ability to read Hebrew or Arabic; and the ability to walk independently 10 meters.

Exclusion Criteria

  • progressive neurological conditions (Parkinson, Multiple sclerosis, CVA); severe orthopedic conditions including lower limb or spine fractures and surgeries in the past 12 months prior to baseline; blindness; Arrhythmia; uncontrolled chronic disease (i.e., hypertension, diabetes, ischemic heart disease); diagnosed severe osteoporosis with a history of fracture during the past 3 years prior to baseline; active cancer during the past three years prior to baseline; lack of availability in the coming two months for completing the treatment protocol

Outcomes

Primary Outcomes

rate of falls and fallers

Time Frame: falls and fallers rates during 12-months following end of treatment

hip fractures and hospitalizations rates due to falls

Time Frame: hip fractures and hospitalizations rates due to falls during12-months following end of treatment

Secondary Outcomes

  • Mini-BESTest(end of treatment-last visit in physical therapy clinic)
  • Activities-Specific Balance Confidence Scale (ABC scale)(12 months after end of treatment)
  • Physical Activity Scale for the Elderly (PASE)(12 months after end of treatment)

Study Sites (3)

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