Effect of Perturbation Training on Balance Control in Elderly Persons (BaMPer)
| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2011 | ||||
| Last Updated Date | September 22, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
voluntary and compensatory step execution times in miliseconds [ Time Frame: change from baseline to 3 months later ] [ Designated as safety issue: Yes ] the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01439451 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres [ Time Frame: Time 1: pre test` and 3 months later time 2: post testing procedure ] [ Designated as safety issue: Yes ] body sway will be measured to evaluate control of posture |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Perturbation Training on Balance Control in Elderly Persons | ||||
| Official Title ICMJE | Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial | ||||
| Brief Summary | The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training. |
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| Detailed Description | A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Accidental Falls | ||||
| Intervention ICMJE | Procedure: perturbation training
The experimental and control groups will participate in 3 month training program twice a week 20 minutes each training session
Other Names:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | August 2014 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 70 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01439451 | ||||
| Other Study ID Numbers ICMJE | BARZI1729 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Ornit Cohen, Barzilai Medical Center | ||||
| Study Sponsor ICMJE | Barzilai Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Barzilai Medical Center | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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