- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073318
Effects of Balance Training in Older Adults With Dementia
Effects of Task-oriented Balance Training in Institutionalized Older Adults With Dementia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 886-108-67
- The Catholic Foundation of Alzheimer's Disease and Related Dementia St. Joseph Home for Alzheimer's Disease and Related Dementia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Balance training
|
4 weeks individualized task-oriented balance training, twice a week and 1 hour each session
|
Active Comparator: Control
Control group received 4 weeks upper extremities exercise in sitting position
|
4 weeks upper extremities exercise in sitting position, twice a week and 1 hour each session weeks |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go test
Time Frame: baseline, post-treatment, 1-month follow up
|
Change from Baseline of Timed Up and Go test
|
baseline, post-treatment, 1-month follow up
|
Berg Balance Scale
Time Frame: baseline, post-treatment, 1-month follow up
|
Change from Baseline of Berg Balance Scale
|
baseline, post-treatment, 1-month follow up
|
walking speed
Time Frame: baseline, post-treatment, 1-month follow up
|
Change from Baseline of walking speed
|
baseline, post-treatment, 1-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-s chair-stand test
Time Frame: baseline, post-treatment, 1-month follow up
|
Change from Baseline of 30-s chair-stand test
|
baseline, post-treatment, 1-month follow up
|
chair sit-and-reach test
Time Frame: baseline, post-treatment, 1-month follow up
|
Change from Baseline of chair sit-and-reach test
|
baseline, post-treatment, 1-month follow up
|
Saint Louis University mental status examination
Time Frame: baseline, post-treatment, 1-month follow up
|
Change from Baseline of Saint Louis University mental status examination
|
baseline, post-treatment, 1-month follow up
|
Barthel index
Time Frame: baseline, post-treatment, 1-month follow up
|
Change from Baseline of Barthel index
|
baseline, post-treatment, 1-month follow up
|
Collaborators and Investigators
Investigators
- Study Chair: Ming-Hsia Hu, Ph.D., School of Physical Therapy, National Taiwan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201011010RB
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