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

Clalit Health Services

Status: Unknown

Conditions: Fall Prevention

Treatments: Device: Balance Tutor Biofeedback Rehabilitation System; Other: Balance and strengthening exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04228159

fall prevention BT

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Perturbation training

Experimental group

Description:

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.

Treatment:

Device: Balance Tutor Biofeedback Rehabilitation System

Balance and strengthening exercise

Active Comparator group

Description:

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.

Treatment:

Other: Balance and strengthening exercise