Self Mobility Improvement in the Elderly by Counteracting Falls (SMILING)

Falls Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877721
• Other study ID #: SOR483209CTIL
• Secondary ID: MZ4832
• Status: Completed
• Phase: N/A
• First received: April 7, 2009
• Last updated: September 19, 2010
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2009
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Soroka University Medical Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falls

Intervention

Device:
• Self Mobility Improvement in the eLderly by using the SMILING system
The effect of treatment with the SMILING system on postural stability and gait of elderly individuals will be measured using RCT cross over study design

Locations

Country	Name	City	State
Israel	SorokaUMC	Beer-Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	European Union

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gait analysis		time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)	No
Secondary	Tinetti's performance-oriented mobility assessment (POMA score), CODEX test, GDS test		time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)	No
Secondary	CODEX test		time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)	No
Secondary	GDS test		time 1: pre test; time 2 post test (4 weeks after pre test) and time 3 follow up (8 weeks after pre test)	No