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

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

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.

Study Overview

• Status: Unknown
• Conditions: Fall Prevention
• Intervention / Treatment: Device: Balance Tutor Biofeedback Rehabilitation System; Other: Balance and strengthening exercise

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Recruiting
    • Clalit Healthcare Services
    • Contact: Anat Shashua, PhD; Phone Number: 972508803223; Email: Anatsh6@clalit.org.il
    • Contact: Igal Levran, MHA BPT; Phone Number: 972506262223; Email: ilevran@clalit.org.il
  • H̱olon, Israel
    • Recruiting
    • Clalit Healthcare Services
    • Contact: Anat Shashua, PhD; Phone Number: 972508803223; Email: Anatsh6@clalit.org.il
    • Contact: Igal Levran, MHA BPT; Phone Number: 972506262223; Email: ilevran@clalit.org.il
  • Nazareth, Israel
    • Recruiting
    • Clalit Healthcare Services
    • Contact: Anat H Shashua, PhD; Phone Number: 972508803223 972508803223; Email: Anatsh6@clalit.org.il
    • Contact: Igal H Levran, MHA BPT; Phone Number: 972508803223 972506262223; Email: ilevran@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Perturbation training; Session1 - baseline assessment (detailed above) Session2 - 13 - each session will begin with reassessment and documentation of balance tutor parameters for each participant as were calibrated at the end of previous session. After reassessment the training program will include: Warm up - walking without perturbation.; Perturbation during standing position.; Perturbation during walking.; Perturbation during tandem position.; Perturbation with vestibular stimulation.; Rest according to patient needs The relative duration of each component, as well as intensity and frequency of perturbations, will be adjusted to each individual according to his ability, reassessment parameters and progression. Session14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.	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
ACTIVE_COMPARATOR: Balance and strengthening exercise; Session1 - baseline assessment (detailed above). Session2 - 13 - each session will include: Warm up (free walking or cycling).; Static balance exercise - standing position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation.; Dynamic balance exercise - walking position. Exercise will be performed using different bases of support (narrow, tandem, and one leg stance), eyes open/closed, unstable surfaces, functional and cognitive dual task, and vestibular stimulation.; Strengthening exercise - general strengthening, particularly for lower limb.; Cool down. Level of difficulty and duration of each component will be adjusted to each individual according to his ability and progression. Session14 - full reassessment of all baseline examinations including: Mini-BESTest, ABC scale, PASE, and number of falls.	Other: Balance and strengthening exercise; exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Clalit Health Services
• Collaborators: MediTouch Ltd.
• Investigators: Principal Investigator: Shlomit Yaron, MD, Clalit health services

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2019
• Primary Completion (ANTICIPATED): May 25, 2021
• Study Completion (ANTICIPATED): May 25, 2022

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Accidental Falls, Frail Elderly, Physical Therapy Specialty
• Other Study ID Numbers: fall prevention BT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No