NCT04455607

Brief Summary

Falls are major contributors for immobility and independency. Most falls in older adults occur during walking after a sudden unexpected loss of balance. It was well-established that balance can be improved by performance of a training program that provides perturbation (unexpected perturbations of balance). The main aim of the current study is to investigate the effects of two perturbation-training methods: 1) random perturbation training; vs. 2) block (non-random) perturbation training. We also aim to explore brain area's (as measured by MRI) that are related to balance function in older adults. We hypothesize that response to an unexpected loss of balance is the balance responses will be improved in both training methods, but more in the random training method. We also hypothesize that brain function as seen in MRI will be improved in both training methods, more in the random training method. As far as we know, there is a lack of studies investigating the learning effect of random vs. block non-random training on balance recovery responses while walking and exposure to unexpected loss of balance and on brain function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 18, 2024

Status Verified

October 1, 2020

Enrollment Period

4.3 years

First QC Date

June 29, 2020

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The step recovery thresholds and brain imaging (MRI)

    The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition we will be testing the correlation between brain activity using brain imaging in both to find whether improvement in motor function are correlated with brain function and anatomy.

    60 minute

Secondary Outcomes (4)

  • Postural stability

    10 minutes

  • Voluntary step test

    6 minutes

  • Berg Balance test

    10 minutes

  • kinematics of walking

    10 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

Random perturbation training

Behavioral: perturbation training

control group

ACTIVE COMPARATOR

Block perturbation training

Behavioral: perturbation training

Interventions

A Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice.

control groupexperimental group

Eligibility Criteria

Age70 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and older (with the young age of 20-40)
  • able to walk independently (without utilities treadmill or stick);
  • Be asked to invent a medical certificate which allows participation in exercise that requires walking twice a week.

You may not qualify if:

  • suffering from ischaemic heart disease which limits exercise and COPD and blood pressure is not controlled;
  • not suffering serious vision problems;
  • does not suffer from this problem: (a score of 24 or higher on MOCA);
  • a year after analyzing the type of hip replacement or knee or broken extremities;
  • Does not suffer any neurological diseases or stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ben-guion University of the Negev,

Beersheba, 84105, Israel

Location

Soroka Medical Center

Beersheba, 84105, Israel

Location

SorokaUMC

Beersheba, 84105, Israel

Location

Related Publications (2)

  • Paran I, Nachmani H, Salti M, Shelef I, Melzer I. Balance recovery stepping responses during walking were not affected by a concurrent cognitive task among older adults. BMC Geriatr. 2022 Apr 6;22(1):289. doi: 10.1186/s12877-022-02969-w.

  • Nachmani H, Paran I, Salti M, Shelef I, Melzer I. Examining Different Motor Learning Paradigms for Improving Balance Recovery Abilities Among Older Adults, Random vs. Block Training-Study Protocol of a Randomized Non-inferiority Controlled Trial. Front Hum Neurosci. 2021 Feb 25;15:624492. doi: 10.3389/fnhum.2021.624492. eCollection 2021.

Study Officials

  • ilan Shelef, MD

    Soroka University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 2, 2020

Study Start

October 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 18, 2024

Record last verified: 2020-10

Locations