Effect of Perturbation Training on Balance Control in Elderly Persons

Accidental Falls Clinical Trial

— BaMPer  

Official title:

Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439451
• Other study ID #: BARZI1729
• Status: Completed
• Phase: N/A
• First received: September 11, 2011
• Last updated: August 5, 2015
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Barzilai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Procedure:
• perturbation training
The experimental and control groups will participate in 3 month training program twice a week 20 minutes each training session

Locations

Country	Name	City	State
Israel	Beit Yona	Beer-Sheva
Israel	Ben-Gurion University of the Negev	Beer-sheva

Sponsors (1)

Lead Sponsor	Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	voluntary and compensatory step execution times in miliseconds	the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds	change from baseline to 3 months later	Yes
Secondary	postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres	body sway will be measured to evaluate control of posture	Time 1: pre test` and 3 months later time 2: post testing procedure	Yes