Perturbation Training Compared to Balance and Strengthening Exercise, for Elderly at Risk of Falling
- Conditions
- Fall Prevention
- Interventions
- Other: Balance and strengthening exerciseDevice: Balance Tutor Biofeedback Rehabilitation System
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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.
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
- Arm && Interventions
Group Intervention Description Balance and strengthening exercise 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. Perturbation training Balance Tutor Biofeedback Rehabilitation System 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.
- 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