NCT04213521

Brief Summary

The study aimed to investigate the effectiveness of multisensory balance training on the levels of visual dependence and sensory organization capacity in community-dwelling older adults. Participants in the experimental group received multisensory balance training while those in the control group received conventional balance training without sensory manipulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
Last Updated

December 30, 2019

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

December 19, 2019

Last Update Submit

December 24, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rod and Disc Test

    It is a computerized test which measures levels of visual dependence. Greater errors from true vertical indicates the greater levels of visual dependence.

    Change from baseline to post-intervention at 4-8 weeks

  • Modified clinical test of sensory interaction in balance

    It assess the contribution of the visual, somatosensory, and vestibular systems to postural control.

    Change from baseline to post-intervention at 4-8 weeks

Secondary Outcomes (6)

  • Chair sit and reach test

    Change from baseline to post-intervention at 4-8 weeks

  • Five times sit to stand test

    Change from baseline to post-intervention at 4-8 weeks

  • Berg balance scale

    Change from baseline to post-intervention at 4-8 weeks

  • The Activities specific Balance Confidence Scale

    Change from baseline to post-intervention at 4-8 weeks

  • Timed up and go test

    Change from baseline to post-intervention at 4-8 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • mini mental state examination

    During screening

Study Arms (2)

Multisensory balance training group

EXPERIMENTAL

The participants in the multisensory balance training group were provided with multiple-sensory balance exercises using visual, proprioceptive, and vestibular manipulations. The exercises involved movements of the eye, head, and body to stimulate the vestibular system-postural control exercises in different positions (feet together, tandem stance, and one leg stance), use of a soft surface to reduce the proprioceptive inputs, and exercises with closed eyes to deprive them of visual cues.

Other: Multisensory balance exerciseOther: Conventional balance exercise

Conventional balance training group

ACTIVE COMPARATOR

The participants in the Conventional balance training group performed conventional balance exercises, such as static and dynamic standing balance without altered sensory inputs.

Other: Conventional balance exercise

Interventions

Multisensory balance training describes a balance exercise incorporating individual sensory manipulation of vision, vestibular, proprioception and sensory integration.

Multisensory balance training group

such as static and dynamic standing balance without altered sensory inputs.

Conventional balance training groupMultisensory balance training group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • \) age more than 60 years
  • \) able to walk continuously for 10 meters independently without aid
  • \) normal cognitive function with a Mini-Mental State Examination score more than 24
  • \) able to follow oral commands.

You may not qualify if:

  • any medical condition or recent injury that could affect the assessment of balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Shu-Chun Lee, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 30, 2019

Study Start

March 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

December 30, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

would like to share if other researchers officially request

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
applicants need to provide their research background, purposes and the reasons why they request IPD, principal investigator will review the applicants, affiliations and all the documents mentioned above.

Locations