Status:
COMPLETED
Self Mobility Improvement in the Elderly by Counteracting Falls (SMILING)
Lead Sponsor:
Soroka University Medical Center
Collaborating Sponsors:
European Union
Conditions:
Falls
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Experimental design overview: The proposed project is a prospective experimental study design. Independent old adults (age 65 years old and older) who suffer from minor balance problems willing to pa...
Eligibility Criteria
Inclusion
- The inclusion criteria are:
- Self-reported information
- age ≥ 65 years,
- able to walk at least 20 meters independently, i.e., without personal assistance and without an assistive device, except for a single point cane
- one or more falls in the previous year (falls during sport activities excluded).
- Standardized physical and cognitive functional tests
- Tinetti's POMA score below 26 (strictly)
- MMSE test with score ≥ 24
- GDS test with score \<10
- The exclusion criteria are:
- Self-reported information
- age \< 65 years
- inability to walk 20 meters safely (self-report) or walk with personal assistance or with an assistive device (except single point cane for fallers)
- inability to recall fall status in the previous year
- severe visual impairment (e.g., impaired ability to read, watch TV, or drive a car)
- severe hearing impairment (e.g., unable to follow a conversation, to use a phone)
- Standardized physical and cognitive functional tests
- Tinetti's POMA score less than 19
- MMSE score \< 24
- GDS test with score ≥ 10
- Medical conditions (filled in by the family doctor of the subject)
- wearing a pacemaker, a cardiac defibrillator or any other electronic implant
- severe gait impairment precluding safe walking over 20 meters due to:
- focal lower limb muscle weakness or palsy (e.g., unable to raise leg/foot from floor)
- neurological diseases, including diseases such as severe Parkinson's disease, Multiple Sclerosis, status post stroke with hemi-syndroma, cervical or lumbar stenosis with compression myelopathy, polyneuropathy with severe proprioceptive impairment, Menier
- severe cardiovascular disease
- foot problems, lower limb amputation or joint arthrodesis
- terminal diseases (defined as estimated life expectancy of less than 6 months).
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00877721
Start Date
April 1 2010
End Date
July 1 2010
Last Update
September 21 2010
Active Locations (1)
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1
SorokaUMC
Beersheba, Israel, 84105