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Completed

NCT Number: NCT03473834

Modified Exercise Programme in Individuals With Parkinson's Disease

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Muscle Hypertonia Muscle Rigidity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Sports Science and Technology

Nakhon Pathom, 73170, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified exercise programme

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

Behavioral

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

Primary outcomes

  1. Reorientation onset of body segment

    Time frame: 5 months

    Previous research has shown that turning in healthy adults is a whole-body coordinated process characterized by a top-down sequence of body segments reorientation starting with the eyes and head followed by the trunk and ending with the feet (Hollands, Ziavra, & Bronstein, 2004; Mak et al., 2008). However, Lohnes and Earhart (2011) provided evidence that impaired turn performance in PD patients could be partially explained by eye movement deficits, affecting eye, head and body coordination (Lohnes & Earhart, 2011).

  2. Functional Reach test

    Time frame: 5 months

    To assess clinical balance

  3. Fall Efficacy Score (FES-I)

    Time frame: 5 months

    FES-I is a questionnaire to assess fear of falling (31). There is 16-item which developed by the Prevention of Falls Network Europe group (ProFaNE) to augment content covered by the original 10-item Fall Efficacy Score (FES). Participants will be asked to rate 16 items of questionnaire on a four-point Likert scale which is their concerns about the possibility of falling when performing 16 activities. A total score is 64 score, a higher score indicates a greater fear of falling.

  4. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: 5 months

    The Unified Parkinson's Disease Rating Scale, abbreviated UPDRS is a scoring system widely used for the clinical evaluation of Parkinson's disease (PD). Its 42 items are evaluated by interview and clinical observation. Clinicians and researchers alike use the UPDRS and the motor section in particular to follow the progression of a person's Parkinson's disease. Scientific researchers use it to measure benefits from a given therapy in a more unified and accepted rating system. Neurologists also use it in clinical practice to follow the progression of their patients' symptoms in a more objective manner.

    A total of 199 points are possible (199 represents the worst disability and 0 no disability).

  5. Body Mass Index (BMI)

    Time frame: 5 months

    weight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. Borge Scale

    Time frame: 5 months

    To monitor and quantify individual's perceptions of effort during exercise. The Borge scale is used to measure the intensity of your exercise. The Borge scale runs from 0 - 10. The numbers below relate to phrases used to rate how easy or difficult you find an activity. For example, 0 (nothing at all) would be how you feel when sitting in a chair; 10 (very, very heavy) is how you feel at the end of an exercise stress test or after a very difficult activity.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Liverpool John Moores University

Registry information

Official study title

Responses of Modified Exercise Programme on Improvement of Axial Rigidity and Turning Dysfunction in Individuals With Parkinson's Disease

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2018
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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