NCT04473885

Brief Summary

This is a single-blinded randomized controlled trial with pre- and post- measurements. Forty community-dwelling elderly (age\> 65 y/o) with fall risk (defined as functional reach test≦25.4 cm) will be recruited and randomly assigned to experimental group or control group (n=20 for each group). Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks. Participants in the control group will remain their regular activity without additional training. The primary outcomes include the limit of stability (LOS) of posture control by Balance Master® and brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG). Secondary outcomes include the sensory organization test (SOT), Berg balance scale (BBS), and falls efficacy scale International (FES-I).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

July 12, 2020

Last Update Submit

November 12, 2021

Conditions

Old Age; DebilityFall

Keywords

Perturbation-based balance trainingPostural controlCortical modulationElderly

Outcome Measures

Primary Outcomes (2)

  • Limits of Stability

    Assessing posture control by Balance Master®

    15 minutes

  • Cortical modulation

    Assessing brain modulation by Event-Related Desynchronization (ERD) collected by electroencephalogram (EEG)

    1 hour

Secondary Outcomes (3)

  • Sensory Organization Test

    15 minutes

  • Berg Balance Scale

    15 minutes

  • Falls Efficacy Scale International

    15 minutes

Study Arms (2)

Perturbation-based balance training group

EXPERIMENTAL

Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.

Other: Perturbation-based balance training

Control group

NO INTERVENTION

Participants in the control group will remain their regular activity without additional training.

Interventions

Perturbation-based balance trainingOTHER

Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.

Perturbation-based balance training group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Over 65 y/o community-dwelling elderly with fall risk (Functional reach test ≦25.4 cm).
  • Mini-Mental State Examination score (MMSE) ≧ 24.
  • Able to walk independently without assistance at least 10 meters.

You may not qualify if:

  • With any neurological, mental or cognitive disorders, and orthopedic, pulmonary or cardiac problems that could restrict or preclude their participation in exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ray-Yau Wang

    National Yang Ming Chiao Tung University, Taiwan, R.O.C.

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 16, 2020

Study Start

August 31, 2020

Primary Completion

May 17, 2021

Study Completion

May 17, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)