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

NCT00877721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-09-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Yakov Grinshpon, MD · Soroka University Medical Center

  • Itshak Melzer, PhD · Ben-Gurion University of the Negev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • Israel

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877721 on ClinicalTrials.gov