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Sponsors and Collaborators: |
Soroka University Medical Center European Union |
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Information provided by: | Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT00877721 |
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.
Condition | Intervention |
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Falls |
Device: Self Mobility Improvement in the eLderly by using the SMILING system |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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balance treatment: Experimental |
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
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
The inclusion criteria are:
Self-reported information
Standardized physical and cognitive functional tests
The exclusion criteria are:
Contact: Itsahk Melzer, PhD | 972-8-6477727 | itzikm@bgu.ac.il |
Israel | |
SorokaUMC | |
Beer-Sheva, Israel, 84105 |
Study Chair: | Yakov Grinshpon, MD | Soroka University Medical Center |
Principal Investigator: | Itshak Melzer, PhD | Ben-Gurion University of the Negev |
Responsible Party: | Ben-Gurion University of the Negev ( Itshak Melzer PhD, PT ) |
Study ID Numbers: | SOR4832CTIL, MZ4832 |
Study First Received: | April 7, 2009 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00877721 History of Changes |
Health Authority: | Israel: Soroka University Medical Center |
Postural Control Gait Falls Elderly Old adults (65 years old and older) with low risk of falls |