An interventional study of Balance Tutor Biofeedback Rehabilitation System and Balance and strengthening exercise in Fall Prevention, sponsored by Clalit Health Services. Status unknown at 3 sites in Israel. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Clalit Health Services · Not applicable, Interventional, and Treatment
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.
Clalit Health Services is the lead sponsor of 44 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:at least one fall during the last 12 months; age 65-85; 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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance
rate of falls and fallers
Time frame: falls and fallers rates during 12-months following end of treatment
hip fractures and hospitalizations rates due to falls
Time frame: hip fractures and hospitalizations rates due to falls during12-months following end of treatment
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
Time frame: 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".
Time frame: 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
Time frame: 12 months after end of treatment
Plan to share: No
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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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