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Effect of Perturbation Training on Balance Control in Elderly Persons (BaMPer)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ornit Cohen, Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT01439451
First received: September 11, 2011
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Accidental Falls
 Procedure: perturbation training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Falls
U.S. FDA Resources

Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 48
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental
perturbation training during walking
 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:
  • treadmill walking
  • perturbation training during walking
Active Comparator: controls
treadmill walking
 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:
  • treadmill walking
  • perturbation training during walking

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 70 years or older, male or female
  • Be an independent ambulator (not cane or walker) and provide medical waiver from MD.

Exclusion Criteria:

  • Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty
  • Moderate-severe dementia (Mini-Mental Score < 24).
  • Serious visual impairment
  • Severe peripheral or compression/entrapment neuropathies.
  • Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.
  • Cancer, metastatic or under active treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439451

Locations
Israel
Ben-Gurion University of the Negev
Beer-sheva, Israel, 84105
Beit Yona
Beer-Sheva, Israel
Sponsors and Collaborators
Barzilai Medical Center
Investigators
Study Chair: Ronen Debi, MD Barzilai Medical Center
  More Information

No publications provided

Responsible Party: Ornit Cohen, IRB Coordinator, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT01439451     History of Changes
Other Study ID Numbers: BARZI1729
Study First Received: September 11, 2011
Last Updated: September 22, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Barzilai Medical Center:
Balance control
Aging
Balance reactions
Perturbation
above seventy years old

ClinicalTrials.gov processed this record on May 23, 2013