Effect of Perturbation Training on Balance Control in Elderly Persons

NCT ID: NCT01439451

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Accidental Falls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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experimental

perturbation training during walking

Group Type EXPERIMENTAL

perturbation training

Intervention Type PROCEDURE

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

controls

treadmill walking

Group Type ACTIVE_COMPARATOR

perturbation training

Intervention Type PROCEDURE

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

Interventions

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perturbation training

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

Intervention Type PROCEDURE

Other Intervention Names

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treadmill walking perturbation training during walking

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Barzilai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ornit Cohen

IRB Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronen Debi, MD

Role: STUDY_CHAIR

Barzilai Medical Center

Locations

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Ben-Gurion University of the Negev

Beersheba, , Israel

Site Status

Beit Yona

Beersheba, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 32689965 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32069450 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26944706 (View on PubMed)

Other Identifiers

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BARZI1729

Identifier Type: -

Identifier Source: org_study_id

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