Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling

Not Applicable

• Conditions: Fall Prevention

• Registration Number: NCT04228159
• Lead Sponsor: Clalit Health Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-25
• Status Verified: 2019-12
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Last Update Submitted: 2020-01-13
• Study First Posted: 2020-01-14
• Last Update Posted: 2020-01-14
• Primary Completion: 2021-05-25
• Study Completion: 2022-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
rate of falls and fallers	falls and fallers rates during 12-months following end of treatment
hip fractures and hospitalizations rates due to falls	hip fractures and hospitalizations rates due to falls during12-months following end of treatment

Secondary Outcome Measures

Name	Time	Method
Mini-BESTest	end of treatment-last visit in physical therapy clinic	Balance assessment according to Balance Evaluation Systems Test. The Mini-BESTest is a 14 item test scored on a 3-level ordinal scale. The total score is 28 while a lower score indicates severe balance impairment
Activities-Specific Balance Confidence Scale (ABC scale)	12 months after end of treatment	The ABC scale is a 16-item self-report measure in which patients rate their balance confidence for performing activities. Items are rated on a rating scale that ranges from 0-100; 0 represents "no confidence" and 10 represents "complete confidence".
Physical Activity Scale for the Elderly (PASE)	12 months after end of treatment	The PASE measures the level of self-reported physical activity in individuals aged 65 years or older and is comprised of items regarding occupational, household, and leisure activities during the previous 7-days period

Trial Locations

Locations (3)

Clalit HealthCare services; 🇮🇱 Be'er Sheva, Israel

Clalit Healthcare Services; 🇮🇱 H̱olon, Israel

Clalit HealthCare Services; 🇮🇱 Nazareth, Israel