Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001121358
Ethics application status
Approved
Date submitted
1/02/2016
Date registered
31/07/2017
Date last updated
31/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Multisensory Training on Dual Task Performances in Community-dwelling Older Adults
Scientific title
Effects of Multisensory Training on Dual Task Performances in Community-dwelling Older Adults
Secondary ID [1] 288459 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aging 300235 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297673 297673 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants chose to join the experimental group receiving one-hour multisensory training, three times a week for twelve weeks or the control group receiving one-hour healthy education, one time for every two-week, total for six sessions. All participants were assessed at baseline, mid-test at 8th week and post-intervention.
Training procedure for Experimental Group:
For participants in the experimental group, all subjects attended 36 individual training sessions, lasting approximately 60 min, 3 times a week for 12 weeks. Each session started with a 10-mintue warming up and a 10-mintue cool down period of stretching after training. Subjects underwent the multisensory training program consisting of: (1) Proprioceptive training, mainly for the lower limbs; (2) Vestibular and eye control training; (3) Facilitation and integration of proprioceptive and vestibular impulses. For each session, a physical therapist guided participants to accomplish each training program. The intensity progressed when the participant adapt to the program and show the better performance. The program included:
1. Proprioception (Bare foot)
Standing (including balance cushion, trampoline)
Weight shifting all direction
Stamping feet on the spot
Walking
Uneven surface & different texture

2. Vestibular & eye control
Sitting & Standing
Head (quick) rotation with eye fixed
Head (quick) rotation with eye followed
Head (quick) rotation with eye closed
Standing
Disc rotation with eye open and closed
Walking and bouncing

3. Combined proprioception and vestibular
Standing on a balance cushion or trampoline
Head (quick) rotation with eye fixed
Head (quick) rotation with eye followed
Head (quick) rotation with eye closed
Reaching for an object in different direction
Catching and throwing ball
Keeping a balloon in the air
Walking
Catching and throwing ball
Keeping a balloon in the air
Moving head or fixing gaze
Quick turn
The adherence of participants is register of attendance at sessions.
Intervention code [1] 293789 0
Rehabilitation
Comparator / control treatment
Training procedure for Control Group:
A one-hour session of healthy promotion education provided by a physical therapist was given to participants every two-week. 6 sessions over 12 weeks in totals. Education included issue of how to choose suitable exercises, illness knowledge and fall-prevented education and the educations are present by small group presentation session.
Control group
Active

Outcomes
Primary outcome [1] 297214 0
The Motor Dual Task is assessed by the completed time of Timed Up and Go with motor task. It's performed as holding a cup with full water when the Timed Up and Go.
Timepoint [1] 297214 0
baseline, mid-test at 8th week and post-intervention.
Primary outcome [2] 299585 0
The Cognitive Dual Task is assessed by the completed time of Timed Up and Go with cognitive task. It's performed as counting backwards by 7 from 80 to 90 when the Timed Up and Go.
Timepoint [2] 299585 0
baseline, mid-test at 8th week and post-intervention.
Secondary outcome [1] 320365 0
Functional mobility, assessed using the Timed Up and Go
Timepoint [1] 320365 0
baseline, mid-test at 8th week and post-intervention.
Secondary outcome [2] 327619 0
Dynamic balance, assessed using the Berg Balance Scale (BBS)
Timepoint [2] 327619 0
baseline, mid-test at 8th week and post-intervention.
Secondary outcome [3] 327620 0
Balance confidence assessed by using Activities-Specific Balance Confidence Scale Chinese Version
Timepoint [3] 327620 0
baseline, mid-test at 8th week and post-intervention
Secondary outcome [4] 327622 0
gait speed, assessed by using Ten Meter Walk Test (10MWT)
Timepoint [4] 327622 0
baseline, mid-test at 8th week and post-intervention
Secondary outcome [5] 327625 0
postural stability during various walking tasks, assessed by using Functional Gait Assessment (FGA)
Timepoint [5] 327625 0
baseline, mid-test at 8th week and post-intervention

Eligibility
Key inclusion criteria
1. greater or equal than 65 years old
2. Mini-Mental State Examination greater than 24
3. able to walk 10m independently
4. able to participant this training program
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. suffered neurological disorder;2. musculoskeletal impacts limb mobilities;3. had exercise training within 6 months;4. has headache or fall experience within one month; 5. has vestibular disorders

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
The effective sample size in this study was 46 based on an effect size f of 0.35, a type I error of 0.05, an 50 percent power, at least 23 patients in each group were required for identifying statistically significant differences in primary performance (two-way ANOVA). Considering about the drop out rate, we set the target sample size to 50.
Two way ( group by time ) repeated measures analysis of variance will be used to analyze dependent variables. The independent t test and Tukey post hoc test will be used to analyze data between two group. The significance was accepted for values of p less than 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 7565 0
Taiwan, Province Of China
State/province [1] 7565 0

Funding & Sponsors
Funding source category [1] 292801 0
University
Name [1] 292801 0
National Yang Ming University
Country [1] 292801 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang Ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 291541 0
None
Name [1] 291541 0
Address [1] 291541 0
Country [1] 291541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294303 0
National Yang-Ming University Office of Research and Development
Ethics committee address [1] 294303 0
Ethics committee country [1] 294303 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294303 0
21/09/2015
Approval date [1] 294303 0
28/01/2016
Ethics approval number [1] 294303 0
YM104095F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63226 0
Prof Yea-Ru Yang
Address 63226 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 63226 0
Taiwan, Province Of China
Phone 63226 0
+886228267279
Fax 63226 0
Email 63226 0
[email protected]
Contact person for public queries
Name 63227 0
Hus, ko-ning
Address 63227 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 63227 0
Taiwan, Province Of China
Phone 63227 0
+886931514666
Fax 63227 0
Email 63227 0
[email protected]
Contact person for scientific queries
Name 63228 0
Yea-Ru Yang
Address 63228 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 63228 0
Taiwan, Province Of China
Phone 63228 0
+886228267279
Fax 63228 0
Email 63228 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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