Effects of Balance Training in Older Adults With Dementia

• ClinicalTrials.gov Identifier: NCT02073318
• Recruitment Status: Completed
• First Posted: February 27, 2014
• Last Update Posted: February 27, 2014
• Sponsor: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

Tracking Information

• First Submitted Date: January 20, 2011
• First Posted Date: February 27, 2014
• Last Update Posted Date: February 27, 2014
• Study Start Date: December 2010
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dementia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2014): 19
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT02073318
• Other Study ID Numbers: 201011010RB
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Taiwan University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: National Taiwan University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Ming-Hsia Hu, Ph.D.; School of Physical Therapy, National Taiwan University

• PRS Account: National Taiwan University Hospital
• Verification Date: February 2014