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Effects of Balance Training in Older Adults With Dementia

Primary Purpose

Dementia

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Task-oriented balance training
Upper extremities exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balance training

Control

Arm Description

Control group received 4 weeks upper extremities exercise in sitting position

Outcomes

Primary Outcome Measures

Timed Up and Go test
Change from Baseline of Timed Up and Go test
Berg Balance Scale
Change from Baseline of Berg Balance Scale
walking speed
Change from Baseline of walking speed

Secondary Outcome Measures

30-s chair-stand test
Change from Baseline of 30-s chair-stand test
chair sit-and-reach test
Change from Baseline of chair sit-and-reach test
Saint Louis University mental status examination
Change from Baseline of Saint Louis University mental status examination
Barthel index
Change from Baseline of Barthel index

Full Information

First Posted
January 20, 2011
Last Updated
February 25, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02073318
Brief Title
Effects of Balance Training in Older Adults With Dementia
Official Title
Effects of Task-oriented Balance Training in Institutionalized Older Adults With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balance training
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group received 4 weeks upper extremities exercise in sitting position
Intervention Type
Other
Intervention Name(s)
Task-oriented balance training
Intervention Description
4 weeks individualized task-oriented balance training, twice a week and 1 hour each session
Intervention Type
Other
Intervention Name(s)
Upper extremities exercise
Intervention Description
4 weeks upper extremities exercise in sitting position, twice a week and 1 hour each session weeks
Primary Outcome Measure Information:
Title
Timed Up and Go test
Description
Change from Baseline of Timed Up and Go test
Time Frame
baseline, post-treatment, 1-month follow up
Title
Berg Balance Scale
Description
Change from Baseline of Berg Balance Scale
Time Frame
baseline, post-treatment, 1-month follow up
Title
walking speed
Description
Change from Baseline of walking speed
Time Frame
baseline, post-treatment, 1-month follow up
Secondary Outcome Measure Information:
Title
30-s chair-stand test
Description
Change from Baseline of 30-s chair-stand test
Time Frame
baseline, post-treatment, 1-month follow up
Title
chair sit-and-reach test
Description
Change from Baseline of chair sit-and-reach test
Time Frame
baseline, post-treatment, 1-month follow up
Title
Saint Louis University mental status examination
Description
Change from Baseline of Saint Louis University mental status examination
Time Frame
baseline, post-treatment, 1-month follow up
Title
Barthel index
Description
Change from Baseline of Barthel index
Time Frame
baseline, post-treatment, 1-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Hsia Hu, Ph.D.
Organizational Affiliation
School of Physical Therapy, National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
The Catholic Foundation of Alzheimer's Disease and Related Dementia St. Joseph Home for Alzheimer's Disease and Related Dementia
City
Taipei
ZIP/Postal Code
886-108-67
Country
Taiwan

12. IPD Sharing Statement

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Effects of Balance Training in Older Adults With Dementia

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