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Completed

NCT Number: NCT01439451

Effect of Perturbation Training on Balance Control in Elderly Persons

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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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beit Yona, Beersheba, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

perturbation training

Procedure

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

Primary outcomes

  1. voluntary and compensatory step execution times in miliseconds

    Time frame: change from baseline to 3 months later

    the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds

Secondary outcomes

  1. 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

    body sway will be measured to evaluate control of posture

Sponsors and collaborators

Lead sponsor

Barzilai Medical Center

Other

Registry information

Official study title

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

Acronym: BaMPer

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Sep 23, 2011
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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