Clinical trial NCT03473834: Modified Exercise Programme in Individuals With Parkinson's Disease
Official title: Responses of Modified Exercise Programme on Improvement of Axial Rigidity and Turning Dysfunction in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Exercise
Rigidity
Turning
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Liverpool John Moores University
First posted: 2018-03-22
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Only patients with PD who meet the inclusion and exclusion criteria will be invited to participate in the study. All participants will be assessed for daily activity and motor skill using the Unified Parkinson's Disease Rating Scale (UPDRS). At pre- and post- assessments, eye movement and turning characteristics will be assessed using xIMU sensors and EOG.
Primary purpose: TREATMENT

Brief summary: A feasibility study using measures of turning function derived from Inertial Measurement Unit sensory before, and after, a modified exercise programme approach.

Detailed description: Participants will be patients diagnosed as having idiopathic PD by a neurologist. Patients will be recruited from the Movement Disorder Clinic, Division of Neurology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand. Participants will be classified into two groups; the treatment and the control groups. All participants will be asked to sign an informed consent form approved by the ethical committee of Mahidol University Institutional Review Board, Mahidol University, Thailand. Only patients with PD who meet the inclusion and exclusion criteria will be invited to participate in the study. All participants will be assessed for daily activity and motor skill using the Unified Parkinson's Disease Rating Scale (UPDRS). At pre- and post- assessments, eye movement and turning characteristics will be assessed using Inertial Measurement Unit sensors and Electroocculography (EOG). The treatment group will receive a rehabilitation program by the physiotherapist. The rehabilitation sessions will take place at the Faculty of Physical Therapy, Mahidol University, Thailand. The control group will receive a diary for recording their daily activities during the duration of participation in this study. In addition, the researcher will phone participants once per week to remind then to maintain their diary records.

Data Processing \& Analysis: this study will be used the outcome measures and processing data in MATLAB.

Statistical analysis: Kolmogorov Smirnov Goodness of Fit Test will be used to test the data distribution. If the data are normal or non-normal distribution, data comparisons will be tested as the following;

* Normal distribution: Mixed model ANOVA will be used to compare outcome measures between pre- and post- and between the treatment and the control groups
* Non-normal distribution: The Mann-Whitney U test will be used to compare outcome measures between the treatment and control groups. Wilcoxon Signed-Rank test will be used to compare outcome measures between pre- and post- assessments within group.

Eligibility criteria: Inclusion Criteria:

* Presenting clinical diagnosis of Parkinson's disease stage 2 to 3 by modified Hoehn and Yahr Scale assessment
* Age ranges from 50-75 years
* Having stable PD medication usage at least 1 month
* No wearing-off phenomenon
* Able to walk independently without using any assistive device
* Able to follow commands and instruction

Exclusion Criteria:

* Presenting clinical diagnosis of dementia
* Having other neurological, cardiopulmonary, or lower extremities musculoskeletal problems which influence the test performance.
* Having high blood pressure \[more than 140/90 mmHg\]
* Having hemodialysis
* Having visual problems which cannot be adjusted by the lens or glasses

Primary outcomes:
measure: Reorientation onset of body segment
timeFrame: 5 months
measure: Functional Reach test
timeFrame: 5 months
measure: Fall Efficacy Score (FES-I)
timeFrame: 5 months
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 5 months
measure: Body Mass Index (BMI)
timeFrame: 5 months
Secondary outcomes:
measure: Borge Scale
timeFrame: 5 months
Other outcomes:
Locations:
city: Nakhon Pathom
country: Thailand
facility: College of Sports Science and Technology
Study officials:
affiliation: Mahidol University
name: Fuengfa Khobkhun
role: PRINCIPAL_INVESTIGATOR
References: