Clinical trial NCT04228159: Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fall Prevention
Keywords: Accidental Falls, Frail Elderly, Physical Therapy Specialty
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: MediTouch Ltd.
First posted: 2020-01-14
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial. Older adults at moderate and high risk of falling will be recruited among Clalit patients referred to one of three physical therapy clinics, or other clinics nearby, neither by physician referral due to gait abnormality or following the physiotherapist diagnosis. Potential participants fulfilling the inclusion criteria and not meeting the exclusion criteria will sign informed consent and continue with baseline assessment. Those not wishing to participate will continue with routine care. Once the baseline assessment is completed, participants will be randomized into one of two intervention groups using computer random allocation software. Participants in both groups will attend physical therapy clinics twice a week for a total of 14 sessions. Each session will last 30 minutes. General information regarding fall prevention will be delivered to all participants using Clalit brochures and electronic prescriptions
Primary purpose: TREATMENT

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.


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.

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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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Primary outcomes:
measure: rate of falls and fallers
timeFrame: falls and fallers rates during 12-months following end of treatment
measure: hip fractures and hospitalizations rates due to falls
timeFrame: hip fractures and hospitalizations rates due to falls during12-months following end of treatment
Secondary outcomes:
measure: Mini-BESTest
timeFrame: end of treatment-last visit in physical therapy clinic
measure: Activities-Specific Balance Confidence Scale (ABC scale)
timeFrame: 12 months after end of treatment
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 12 months after end of treatment
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Clalit HealthCare services
city: H̱olon
country: Israel
facility: Clalit Healthcare Services
city: Nazareth
country: Israel
facility: Clalit HealthCare Services
Study officials:
affiliation: Clalit Health Services
name: Shlomit Yaron, MD
role: PRINCIPAL_INVESTIGATOR
References: