DementiaPhase 2NCT02073318
Effects of Balance Training in Older Adults With Dementia
A Phase 2 study testing Task-oriented balance training and Upper extremities exercise in people with Dementia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Task-oriented balance training and Upper extremities exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
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
About this study
Official title: 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.
- Conditions
- Dementia
- Being tested
- Task-oriented balance training, Upper extremities exercise
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented balance trainingOther
4 weeks individualized task-oriented balance training, twice a week and 1 hour each session
Upper extremities exerciseOther
4 weeks upper extremities exercise in sitting position, twice a week and 1 hour each session
weeks
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | Not described Receives: Other: Task-oriented balance training |
| Control | Active comparator | Control group received 4 weeks upper extremities exercise in sitting position Receives: Other: Upper extremities exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go test
Change from Baseline of Timed Up and Go test
Measured: baseline, post-treatment, 1-month follow up
Berg Balance Scale
Change from Baseline of Berg Balance Scale
Measured: baseline, post-treatment, 1-month follow up
walking speed
Change from Baseline of walking speed
Measured: baseline, post-treatment, 1-month follow up
Secondary outcomes (4)
30-s chair-stand test
Change from Baseline of 30-s chair-stand test
Measured: baseline, post-treatment, 1-month follow up
chair sit-and-reach test
Change from Baseline of chair sit-and-reach test
Measured: baseline, post-treatment, 1-month follow up
Saint Louis University mental status examination
Change from Baseline of Saint Louis University mental status examination
Measured: baseline, post-treatment, 1-month follow up
Barthel index
Change from Baseline of Barthel index
Measured: baseline, post-treatment, 1-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Hsia Hu, Ph.D., Study chair, School of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073318
- Sponsor's protocol ID
- 201011010RB
- Status last verified
- Feb 2014
- First submitted
- 20 Jan 2011
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task-oriented Balance Training in Institutionalized Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT02073318
- Acronym / sponsor ID
- 201011010RB
- Conditions
- Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: Task-oriented balance training |
| Control | Active comparator | Other: Upper extremities exerciseControl group received 4 weeks upper extremities exercise in sitting position |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-oriented balance training4 weeks individualized task-oriented balance training, twice a week and 1 hour each session | Other | Balance training |
| Upper extremities exercise4 weeks upper extremities exercise in sitting position, twice a week and 1 hour each session weeks | Other | Control |
Primary outcome
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
4 secondary outcomes
30-s chair-stand test
Time frame: baseline, post-treatment, 1-month follow up
chair sit-and-reach test
Time frame: baseline, post-treatment, 1-month follow up
Saint Louis University mental status examination
Time frame: baseline, post-treatment, 1-month follow up
Barthel index
Time frame: baseline, post-treatment, 1-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Hsia Hu, Ph.D. study chair
School of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Task-oriented balance training and Upper extremities exercise in people with Dementia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go test (time frame: baseline, post-treatment, 1-month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.