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Trial registered on ANZCTR


Registration number
ACTRN12616000198426
Ethics application status
Approved
Date submitted
18/12/2015
Date registered
15/02/2016
Date last updated
15/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Different training strategies to improve turning performance, functional mobility and brain activity in individuals with Parkinson’s disease
Scientific title
To investigate the effects of different training strategies on turning performance, functional mobility and brain activity in individuals with Parkinson's disease.
Secondary ID [1] 288178 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 297080 0
Condition category
Condition code
Neurological 297315 297315 0 0
Neurodegenerative diseases
Physical Medicine / Rehabilitation 297316 297316 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in each group received one-on-one 30 minutes of specific exercise, turning-based treadmill training, or control exercise, respectively, followed by a 10-minute turning/walking training on a level surface for a total of 12 sessions over a 4–6-week period by a physiotherapist. All subjects needed to register of attendance at each session to monitor adherence.
Specific exercise: Our previous study found that balance ability and lower extremity muscle strength correlated significantly with turning performance in individuals with PD. Therefore, participants in the specific exercise group received specific exercise training that included 20 minutes of balance exercises and 10 minutes of muscle strengthening exercises. The balance exercises focused on both static and dynamic standing balance training. For instance, standing on the ground composed of different materials and bases of support, and single leg stance were treatment programs for static balance training. For dynamic balance training, catching/throwing a ball, the ring toss game, and forward reaching to different directions were included. The strengthening training focused on hip extensors, abductors, and knee extensors, which were highly correlated with turning performance. Training intensity began from 50% of maximal voluntary contraction (MVC) for 10 repetitions, and the intensity increased to 75%–80% of MVC progressively. After the individual muscle strengthening exercises, participants performed squatting, stepping up/down in the standing position, and bridging and hip circle activities in the supine position. Normal breathing was emphasized during the training session.
Turning-based training: Participants in the turning-based training group received the 30 minutes turning training on a rotational treadmill. This rotational treadmill (Rmax Science & Technology Co., Ltd., New Taipei City, Taiwan) was designed to provide turning-based (task-specific) training. The basic design principle of this rotational treadmill is similar to the regular treadmill except for its circular, running motor belt. The small radius (0.8 m) forces participants to perform a turning action rather than walking straight.
Following the above-described, 30-minute exercise training for each group, a 10-minute over-the-ground turning program was carried out. This program included S-shaped, 8-shaped, square-shaped, and oval-shaped turning walking with verbal cues for gait correction.
Intervention code [1] 293476 0
Treatment: Other
Intervention code [2] 293794 0
Rehabilitation
Comparator / control treatment
Control exercise: Participants in the control group received 30 minutes of trunk exercises combining upper limb movements in the sitting position that minimally challenged standing balance and lower extremity muscle strength. These exercises included trunk flexion, extension, rotation, and side bending with different arm movements (i.e., shoulder flexion, extension, abduction, rotation, and diagonal lifting and chopping).
Control group
Active

Outcomes
Primary outcome [1] 296884 0
Turning performance:step/quick turn (SQT; Balance Master Registered Trademark system, NeuroCom International, Inc., Clackamas, OR, USA)
Timepoint [1] 296884 0
The outcome was measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Primary outcome [2] 296885 0
Measured brain activity by using EEG (Electroencephalogram, EEG, QuickAmp amplifier, Brain Products GmbH, Munich, Germany).

Timepoint [2] 296885 0
The outcome was measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Secondary outcome [1] 319620 0
Unified Parkinson’s Disease Rating Scale, UPDRS


Timepoint [1] 319620 0
The outcomes were measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Secondary outcome [2] 319621 0
Quality of life scale (the Parkinson’s disease questionnaire-39 item, PDQ-39)
Timepoint [2] 319621 0
The outcome was measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment
Secondary outcome [3] 319622 0
Sensory integration ability was assessed by the sensory organization test (SOT) of the Balance Master Registered Trademark System.
Timepoint [3] 319622 0
All outcomes were measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Secondary outcome [4] 319623 0
Functional gait assessment (FGA)
Timepoint [4] 319623 0
All outcomes were measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Secondary outcome [5] 319624 0
Muscle strength was evaluated using a handheld dynamometer (Power Track II; Jtech Medical Industries Inc., Herber City, UT, USA). The muscle groups tested were trunk flexors/extensors, hip flexors/extensors/abductors/adductors, knee flexors/extensors, and ankle dorsiflexors/plantar flexors. The ‘make’ test method was used during which the examiner held the handheld dynamometer stationary while the subject exerted a maximal force against it; the testing position for each muscle followed standard protocols.
Timepoint [5] 319624 0
All outcomes were measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Secondary outcome [6] 320373 0
Freezing of Gait questionnaire, FOGQ
Timepoint [6] 320373 0
All outcomes were measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Secondary outcome [7] 320374 0
Dynamic balance ability was assessed by the Tinetti balance scale and the limit of stability (LOS) test of the Balance Master Registered Trademark System.
Timepoint [7] 320374 0
All outcomes were measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.
Secondary outcome [8] 320375 0
Fall efficacy scale international, FES-I
Timepoint [8] 320375 0
All outcomes were measured the day before intervention (pre), the day after completing the intervention (post), and on the 30th day after completing the intervention (follow up) by the same rater blinded to group assignment.

Eligibility
Key inclusion criteria
1. Hoehn and Yahr stage I to III
2. ability to walk independently
3. stable medication usage
4. a score of at least 24 on the mini-mental state examination (MMSE)
Minimum age
40 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. unstable medical conditions
2. history of other neurological, cardiopulmonary, or orthopedic diseases known to interfere with participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical Package for the Social Sciences 20.0 software was used for data analysis. Descriptive statistics were generated for all variables, and distributions of variables were expressed as the mean +/- standard deviation. One-way analysis of variance (ANOVA) or Chi-square analysis was used to evaluate the intergroup differences among baseline characteristics. Change values were calculated by subtracting the baseline data from the post-training data or by subtracting the baseline data from the follow-up data. To analyze intergroup differences, the change values were analyzed using a one-way ANOVA by group as a factor, followed by the Tukey post hoc test. Statistical significance was set at p<0.05. The effective sample size in this study was 60 based on the primary outcome effects observed (turning performance) of our previous study. Using an effect size Eta-squared of 0.19, a type I error of 0.05, an 80% power, at least 20 patients in each group were required for identifying statistically significant differences in turning performance (one-way ANOVA). However, after recruited 36 patients, the effect size Eta-squared for turning performance were 0.19 to 0.21, and the power were 80% to 84% which had reached the statistical target. Finally, a total of 36 patients were included in the study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7463 0
Taiwan, Province Of China
State/province [1] 7463 0

Funding & Sponsors
Funding source category [1] 292575 0
Government body
Name [1] 292575 0
Ministry of Science and Technology
Address [1] 292575 0
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
Country [1] 292575 0
Taiwan, Province Of China
Funding source category [2] 292576 0
Hospital
Name [2] 292576 0
Cheng Hsin General Hospital
Address [2] 292576 0
112. No.45,Cheng Hsin St.,Pai-Tou,Taipei
Country [2] 292576 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No. 155, Li-Nong Street Section 2, Pei-Tou District, Taipei, Taiwan 112
Country
Taiwan, Province Of China
Secondary sponsor category [1] 291297 0
Hospital
Name [1] 291297 0
Chang Guan Memorial Hospital
Address [1] 291297 0
No.5, Fuxing St., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)
Country [1] 291297 0
Taiwan, Province Of China
Secondary sponsor category [2] 291304 0
Hospital
Name [2] 291304 0
Mackay Memorial Hospital
Address [2] 291304 0
No.92, Sec. 2, Zhongshan N. Rd., Zhongshan Dist., Taipei City 104, Taiwan (R.O.C.)
Country [2] 291304 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294063 0
Institutional Review Boards of Taipei City Hospital
Ethics committee address [1] 294063 0
8F., No.10, Sec. 4, Ren’ai Rd., Da’an Dist., Taipei City 106, Taiwan (R.O.C.)
Ethics committee country [1] 294063 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294063 0
Approval date [1] 294063 0
15/03/2011
Ethics approval number [1] 294063 0
TCHIRB-1000101
Ethics committee name [2] 294064 0
Institutional Review Boards of Chang Gung Medical Foundation
Ethics committee address [2] 294064 0
No.123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.)
Ethics committee country [2] 294064 0
Taiwan, Province Of China
Date submitted for ethics approval [2] 294064 0
Approval date [2] 294064 0
20/01/2014
Ethics approval number [2] 294064 0
102-3920A3
Ethics committee name [3] 294065 0
Institutional Review Boards of Mackay Memorial Hospital
Ethics committee address [3] 294065 0
No.92, Sec. 2, Zhongshan N. Rd., Zhongshan Dist., Taipei City 104, Taiwan (R.O.C.)
Ethics committee country [3] 294065 0
Taiwan, Province Of China
Date submitted for ethics approval [3] 294065 0
Approval date [3] 294065 0
25/08/2014
Ethics approval number [3] 294065 0
14MMHISO58

Summary
Brief summary
More than 50% of people with Parkinson’s disease (PD) have difficulty in turning while walking. However, there is a lack of effective training programs for improving turning performance. Balance control and lower extremity muscle strength influence turning performance in individuals with PD. On the other hand, specific tasks have been proposed as contemporary training strategies for functional improvement. In this study, two different training strategies were designed and investigated for improving turning performance in individuals with PD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62258 0
Prof Ray-Yau Wang
Address 62258 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 62258 0
Taiwan, Province Of China
Phone 62258 0
+886228267210
Fax 62258 0
Email 62258 0
rywang@ym.edu.tw
Contact person for public queries
Name 62259 0
Prof Ray-Yau Wang
Address 62259 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 62259 0
Taiwan, Province Of China
Phone 62259 0
+886228267210
Fax 62259 0
Email 62259 0
rywang@ym.edu.tw
Contact person for scientific queries
Name 62260 0
Prof Ray-Yau Wang
Address 62260 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 62260 0
Taiwan, Province Of China
Phone 62260 0
+886228267210
Fax 62260 0
Email 62260 0
rywang@ym.edu.tw

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary