Modified Exercise Programme in Individuals With Parkinson's Disease

NCT ID: NCT03473834

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2018-09-15

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified exercise programme

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

Group Type: EXPERIMENTAL

Modified exercise programme

Intervention Type: OTHER

The exercise will be modified from the standardized exercise program (Schenkman, 1998) includes a series of exercises based on the concept that muscle length and coordination.

Medication

Intervention Type: BEHAVIORAL

The control group will be received the normal medication from their doctor.

Parkinson's disease Medication

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

Group Type: ACTIVE_COMPARATOR

Medication

Intervention Type: BEHAVIORAL

The control group will be received the normal medication from their doctor.

Interventions

Modified exercise programme

The exercise will be modified from the standardized exercise program (Schenkman, 1998) includes a series of exercises based on the concept that muscle length and coordination.

Intervention Type: OTHER

Medication

The control group will be received the normal medication from their doctor.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool John Moores University

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fuengfa Khobkhun

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

College of Sports Science and Technology

Nakhon Pathom, , Thailand

Countries

Thailand

Other Identifiers

MU-CIRB 2017/181.1210

Identifier Type: -

Identifier Source: org_study_id