NCT02073318

Brief Summary

Purpose -To investigate whether older adults with dementia who have balance and gait problems can improve their balance and gait function after an individualized 4-week tasks-oriented balance training with sensory manipulation. Hypothesis

  • There is significant difference of Timed Up and Go Test, Berg Balance Scale, walking speed, 30-s chair-stand test, Chair sit-and-reach test and Barthel Index between dementia patients who received tasks-oriented balance training and those didn't receive after 4-weeks training and one month follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

January 20, 2011

Last Update Submit

February 25, 2014

Conditions

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go test

    Change from Baseline of Timed Up and Go test

    baseline, post-treatment, 1-month follow up

  • Berg Balance Scale

    Change from Baseline of Berg Balance Scale

    baseline, post-treatment, 1-month follow up

  • walking speed

    Change from Baseline of walking speed

    baseline, post-treatment, 1-month follow up

Secondary Outcomes (4)

  • 30-s chair-stand test

    baseline, post-treatment, 1-month follow up

  • chair sit-and-reach test

    baseline, post-treatment, 1-month follow up

  • Saint Louis University mental status examination

    baseline, post-treatment, 1-month follow up

  • Barthel index

    baseline, post-treatment, 1-month follow up

Study Arms (2)

Balance training

EXPERIMENTAL
Other: Task-oriented balance training

Control

ACTIVE COMPARATOR

Control group received 4 weeks upper extremities exercise in sitting position

Other: Upper extremities exercise

Interventions

4 weeks individualized task-oriented balance training, twice a week and 1 hour each session

Balance training

4 weeks upper extremities exercise in sitting position, twice a week and 1 hour each session weeks

Control

Eligibility Criteria

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

You may qualify if:

  • Patient provides oral consent, and written consent obtains from next of kin
  • Older than 65 years
  • Diagnosis of dementia, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
  • Can follow order to complete the screening test(Timed Up and Go test)
  • Has balance and gait problems
  • Can standing independently with/without assistive device or can standing with minimal assistance

You may not qualify if:

  • Newly developed cardiopulmonary disease and other exercise contraindications
  • Other neuromuscular or musculoskeletal disease that might affect the outcome(ex. Recent stroke, fracture or orthopedic surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic Foundation of Alzheimer's Disease and Related Dementia St. Joseph Home for Alzheimer's Disease and Related Dementia

Taipei, Taipei, 886-108-67, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Ming-Hsia Hu, Ph.D.

    School of Physical Therapy, National Taiwan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2011

First Posted

February 27, 2014

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations