NCT01439451

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

September 11, 2011

Last Update Submit

August 5, 2015

Conditions

Accidental Falls

Keywords

Balance controlAgingBalance reactionsPerturbationabove seventy years old

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres

    Time 1: pre test' and 3 months later time 2: post testing procedure

Study Arms (2)

experimental

EXPERIMENTAL

perturbation training during walking

Procedure: perturbation training

controls

ACTIVE COMPARATOR

treadmill walking

Procedure: perturbation training

Interventions

perturbation trainingPROCEDURE

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

Also known as: treadmill walking, perturbation training during walking
controlsexperimental

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be 70 years or older, male or female
  • Be an independent ambulator (not cane or walker) and provide medical waiver from MD.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ben-Gurion University of the Negev

Beersheba, 84105, Israel

Location

Beit Yona

Beersheba, Israel

Location

Related Publications (3)

  • 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.

    PMID: 32689965DERIVED

  • 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.

    PMID: 32069450DERIVED

  • 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.

    PMID: 26944706DERIVED

Study Officials

  • Ronen Debi, MD

    Barzilai Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IRB Coordinator

Study Record Dates

First Submitted

September 11, 2011

First Posted

September 23, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

IL(2)