Clinical trial NCT00877721: Self Mobility Improvement in the Elderly by Counteracting Falls (SMILING)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Keywords: Postural Control
Gait
Falls
Elderly
Old adults (65 years old and older) with low risk of falls
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2009-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 participate in the study will be tested with well-established measuring techniques of balance and gait before and 4 weeks after balance training program using the "Self Mobility Improvement in the Elderly by Counteracting Falls" system (SMILING system). The study design is randomized clinical trial (RCT), cross over, single blinded study design where 30 subjects will randomly be allocated into experimental or control groups that will switch groups after 4 weeks of intervention.

Random sequence generation will be performed by a staff member who will not interact with subjects during the balance-testing sessions. Subjects will be informed that they are to be randomly assigned to one of the two groups, both receiving gait training program.

The staff member who administers the training programs will be the only member of the research team aware of the subjects' group allocations.

A 'blinded' research assistant will administer the balance tests and will perform any data processing that involves subjective judgments.

Scripts will be used during testing to ensure that all subjects receive the same instructions.

Testing session between two training periods (T1) will take one week.


Eligibility criteria: The inclusion criteria are:

Self-reported information

1. age ≥ 65 years,
2. able to walk at least 20 meters independently, i.e., without personal assistance and without an assistive device, except for a single point cane
3. one or more falls in the previous year (falls during sport activities excluded).

Standardized physical and cognitive functional tests

1. Tinetti's POMA score below 26 (strictly)
2. MMSE test with score ≥ 24
3. GDS test with score \<10

The exclusion criteria are:

1. Self-reported information
2. age \< 65 years
3. inability to walk 20 meters safely (self-report) or walk with personal assistance or with an assistive device (except single point cane for fallers)
4. inability to recall fall status in the previous year
5. severe visual impairment (e.g., impaired ability to read, watch TV, or drive a car)
6. severe hearing impairment (e.g., unable to follow a conversation, to use a phone)
7. Standardized physical and cognitive functional tests
8. Tinetti's POMA score less than 19
9. MMSE score \< 24
10. GDS test with score ≥ 10
11. Medical conditions (filled in by the family doctor of the subject)
12. wearing a pacemaker, a cardiac defibrillator or any other electronic implant
13. severe gait impairment precluding safe walking over 20 meters due to:
14. focal lower limb muscle weakness or palsy (e.g., unable to raise leg/foot from floor)
15. 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
16. severe cardiovascular disease
17. foot problems, lower limb amputation or joint arthrodesis
18. terminal diseases (defined as estimated life expectancy of less than 6 months).

Primary outcomes:
measure: gait analysis
timeFrame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)
Secondary outcomes:
measure: Tinetti's performance-oriented mobility assessment (POMA score), CODEX test, GDS test
timeFrame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)
measure: CODEX test
timeFrame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)
measure: GDS test
timeFrame: time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: SorokaUMC
Study officials:
affiliation: Soroka University Medical Center
name: Yakov Grinshpon, MD
role: STUDY_CHAIR
affiliation: Ben-Gurion University of the Negev
name: Itshak Melzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: