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

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.

Study Overview

• Status: Completed
• Conditions: Accidental Falls
• Intervention / Treatment: Procedure: perturbation training

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer-Sheva, Israel
    • Beit Yona
  • Beer-sheva, Israel, 84105
    • Ben-Gurion University of the Negev

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Barzilai Medical Center
• Investigators: Study Chair: Ronen Debi, MD, Barzilai Medical Center

Publications and helpful links

General Publications

• Batcir S, Shani G, Shapiro A, Alexander N, Melzer I. The kinematics and strategies of recovery steps during lateral losses of balance in standing at different perturbation magnitudes in older adults with varying history of falls. BMC Geriatr. 2020 Jul 20;20(1):249. doi: 10.1186/s12877-020-01650-4.
• Nachmani H, Shani G, Shapiro A, Melzer I. Characteristics of First Recovery Step Response following Unexpected Loss of Balance during Walking: A Dynamic Approach. Gerontology. 2020;66(4):362-370. doi: 10.1159/000505649. Epub 2020 Feb 18.
• Kurz I, Gimmon Y, Shapiro A, Debi R, Snir Y, Melzer I. Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial. BMC Geriatr. 2016 Mar 4;16:58. doi: 10.1186/s12877-016-0223-4.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 11, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 23, 2011

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Aging; Balance control; Perturbation; Balance reactions; above seventy years old
• Other Study ID Numbers: BARZI1729