NCT00877721

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Falls

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2009-04-08
• Last updated: 2010-09-21

Locations

1 site across 1 country: Israel