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

September 11, 2011
September 22, 2011
August 2011
August 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01439451 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Effect of Perturbation Training on Balance Control in Elderly Persons
Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Accidental Falls
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
  • Experimental: experimental
    perturbation training during walking
    Intervention: Procedure: perturbation training
  • Active Comparator: controls
    treadmill walking
    Intervention: Procedure: perturbation training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
48
August 2014
August 2013   (final data collection date for primary outcome measure)

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.
Both
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01439451
BARZI1729
Yes
Ornit Cohen, Barzilai Medical Center
Barzilai Medical Center
Not Provided
Study Chair: Ronen Debi, MD Barzilai Medical Center
Barzilai Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP