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Effects of Balance Training in Older Adults With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073318
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE January 20, 2011
First Posted Date  ICMJE February 27, 2014
Last Update Posted Date February 27, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
  • Timed Up and Go test [ Time Frame: baseline, post-treatment, 1-month follow up ]
    Change from Baseline of Timed Up and Go test
  • Berg Balance Scale [ Time Frame: baseline, post-treatment, 1-month follow up ]
    Change from Baseline of Berg Balance Scale
  • walking speed [ Time Frame: baseline, post-treatment, 1-month follow up ]
    Change from Baseline of walking speed
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
  • 30-s chair-stand test [ Time Frame: baseline, post-treatment, 1-month follow up ]
    Change from Baseline of 30-s chair-stand test
  • chair sit-and-reach test [ Time Frame: baseline, post-treatment, 1-month follow up ]
    Change from Baseline of chair sit-and-reach test
  • 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
  • Barthel index [ Time Frame: baseline, post-treatment, 1-month follow up ]
    Change from Baseline of Barthel index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Balance Training in Older Adults With Dementia
Official Title  ICMJE Effects of Task-oriented Balance Training in Institutionalized Older Adults With Dementia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dementia
Intervention  ICMJE
  • Other: Task-oriented balance training
    4 weeks individualized task-oriented balance training, twice a week and 1 hour each session
  • Other: Upper extremities exercise

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

    weeks

Study Arms  ICMJE
  • Experimental: Balance training
    Intervention: Other: Task-oriented balance training
  • Active Comparator: Control
    Control group received 4 weeks upper extremities exercise in sitting position
    Intervention: Other: Upper extremities exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2014)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02073318
Other Study ID Numbers  ICMJE 201011010RB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Taiwan University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Taiwan University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ming-Hsia Hu, Ph.D. School of Physical Therapy, National Taiwan University
PRS Account National Taiwan University Hospital
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP