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

Fall Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228159
• Other study ID #: fall prevention BT
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: May 25, 2022

Study information

• Verified date: December 2019
• Source: Clalit Health Services
• Contact: Anat Shashua, PhD
• Phone: 972-50-8803223
• Email: Anatsh6[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

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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

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Related Conditions & MeSH terms

• Fall Prevention

Intervention

Device:
• Balance Tutor Biofeedback Rehabilitation System
Balance Tutor system is a unique technology which allows for several postural control ability assessments as well as reactive response training in both standing and walking using controlled perturbation in simple task or multitask performance. Together with proactive training the system allows for optimal rehabilitation outcome and recovery

Other:
• Balance and strengthening exercise
exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance

Locations

Country	Name	City	State
Israel	Clalit HealthCare services	Be'er Sheva
Israel	Clalit Healthcare Services	H_olon
Israel	Clalit HealthCare Services	Nazareth

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	MediTouch Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of falls and fallers		falls and fallers rates during 12-months following end of treatment
Primary	hip fractures and hospitalizations rates due to falls		hip fractures and hospitalizations rates due to falls during12-months following end of treatment
Secondary	Mini-BESTest	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	end of treatment-last visit in physical therapy clinic
Secondary	Activities-Specific Balance Confidence Scale (ABC scale)	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".	12 months after end of treatment
Secondary	Physical Activity Scale for the Elderly (PASE)	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	12 months after end of treatment