Fall Prevention
Conditions
Keywords
Accidental Falls, Frail Elderly, Physical Therapy Specialty
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.
Interventions
DEVICEBalance 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
exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance
Sponsors
MediTouch Ltd.
Clalit Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Contacts
Primary ContactAnat Shashua, PhD
Backup ContactIgal Levran, MHA BPT
Outcome results
None listed