Modified Exercise Programme in Individuals With Parkinson's Disease

Mahidol University

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Medication; Other: Modified exercise programme

Study type: Interventional

Funder types: Other

Identifiers

NCT03473834

MU-CIRB 2017/181.1210

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Modified exercise programme

Experimental group

Description:

Modified exercise program is the intervention for the exercise group that they will be received this programm over 1 month.

Treatment:

Other: Modified exercise programme

Behavioral: Medication

Parkinson's disease Medication

Active Comparator group

Description:

Medication is the standard treatment for individuals with Parkinson's disease. Therefore, the control group will be received the medication only.

Treatment:

Behavioral: Medication