Effectiveness of Online Program and Task-related Training for Parkinson's Disease

NCT06248073 | Recruiting

• 1 other identifier: 202202160B0C601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of online self-management program and on-site task-related training for people with early stage Parkinson's disease. people with early stage of Parkinson's disease (age range: 45-70 years) will be randomly assigned into the following three groups: control group, online self-management program group and on-site task-related training group.The control group will receive no treatment during the experimental period. For the other two groups, participants will receive the intervention twice a week, one hour per session and 12 sessions in total. The main questions it aims to answer are:

1. 1.the potential impact of motor and non-motor symptoms on activity participation and quality of life for people with early stage of Parkinson's disease (PD).
2. 2.compare and examine the the effectiveness of online self-management program and on-site task-related training for people with early stage Parkinson's disease on activity participation and quality of life.

Conditions

Parkinson Disease; Occupational Therapy; Telerehabilitation; Activities of Daily Living

Keywords

Telerehabilitation; early intervention; patient-reported outcome assessment; self-perception

Outcome Measures

Primary Outcomes (5)

• Purdue Pegboard Test

  The change from baseline in dexterity will be measured by the number of pegs participants can put into the holes as quickly as possible. The higher the score, the better the hand dexterity. The test consists of four tasks: inserting pegs with the right hand, inserting pegs with the left hand, inserting pegs with both hands, and assembling pegs with both hands. The time taken to complete the test will be recorded.

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

• Box and Block test

  The change from baseline in dexterity will be measured by the number of blocks participants can put to another box as quickly as possible. Box and Block test is a commonly used tool in occupational therapy to assess hand dexterity. The patient is seated and the experimenter sits opposite the patient to confirm the testing process. The patient is asked to perform the test with their dominant hand, picking up one block at a time and crossing the partition with the block, placing it in the empty space on the other side. The faster the better. Before the formal test, the patient is given 15 seconds of practice time. The formal test lasts for 1 minute.

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

• Proprioceptive sensitivity Assessment

  The examiner will use a customized apparatus from the Sensorimotor Control Laboratory at the University of Minnesota to assess position sense motion sense acuity. Participants will be tested on the same-side position matching test and the psychophysical discrimination threshold test. The examiner moves the examinee's testing hand from the starting position to the testing position and then moves the examinee's wrist back to the starting position. The instrument will use an adaptive algorithm to determine whether to give a simpler or more difficult displacement for the next trial based on whether the examinee's answer is correct or not. A total of about 20 tests are required, and the test time is about 10-15 minutes. The instrument will record the position matching error.

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

• Nottingham Extended Activities of Daily Living Scale (NEADL)

  This assessment tool is used to measure an individual's capacity for instrumental activities of daily living. Based on the classification of the International Classification of Functioning, Disability, and Health (ICF model), the assessment pertains to the level of activities and participation. It includes a total of 22 items, all of which are activities performed in daily life. Participants are asked to respond based on their actual performance or involvement in these activities over the past few weeks. Each item has four response options for the participant to self-report: can complete independently, can complete independently but with some difficulty, requires assistance from others to complete, and did not perform this activity. Each item is scored on a scale of 0-3, with a total score of 66. The higher the score, the better the patient's ability to perform daily activities of living.

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

• Parkinson's Disease Questionnaire (PDQ-39)

  This self-administered questionnaire consists of 39 questions assessing the quality of life of individuals with Parkinson's disease across eight dimensions, including mobility, activities of daily living, emotional wellbeing, stigma, cognition, social support, communication, and bodily discomfort. The questions ask participants to rate the difficulty they experienced in various activities during the past month of living with Parkinson's disease. There are five response options for each question: Not at all, Occasionally, Sometimes, Often, and Always or cannot do at all, scored from 0 to 4, respectively. A higher score indicates greater difficulty experienced by the participant.

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

Secondary Outcomes (13)

• Time up and go test (TUG)

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

• Grip Strength measure

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

• Pinch Strength measure

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

• Hand length measure

  Baseline (before intervention)

• The University of Pennsylvania Smell Inventory Test (UPSIT)

  Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)

Other Outcomes (2)

• Mini-Mental Status Examination (MMSE)

  Screening-before intervention (one of the inclusive criteria)

• Beck depression scale

  Screening-before intervention (one of the inclusive criteria)

Study Arms (3)

on-line self-management group

EXPERIMENTAL

The investigators plan to conduct 12 sessions of intervention, one hour per session, 2 sessions per week, for a total of 6 weeks. Participants will receive interventions in their home via online meetings with a certified occupational therapist. The training will be related to functional tasks in daily life. In addition, the investigators will guide participants to use self-management skills in their daily routines. Participants will receive booklets to conduct their self-practice and exercise for 30 minutes per session, two sessions per week, for a total of 6 weeks.

Behavioral: on-line self-management training

on-site task-related group

EXPERIMENTAL

The investigators plan to conduct 12 sessions of intervention, one hour per session, 2 sessions per week, for a total of 6 weeks. Participants will receive interventions at Chang Gung Memorial Hospital. A certified occupational therapist will conduct the interventions. The training will include motor function of upper extremities, balance training and functional tasks. The level of difficulty of the tasks will be adjusted based on the participants' abilities.

Behavioral: onsite task-related training

control group

NO INTERVENTION

To compare the two experimental groups in the context of early Parkinson's disease, the control group will not receive any additional intervention and will continue their regular daily activities without changes.

Interventions

onsite task-related training BEHAVIORAL

Participants will receive interventions at Chang Gung Memorial Hospital. A certified occupational therapist will conduct the interventions. These sessions will involve functional tasks tailored to each participant's skill level, with two to four varied tasks per session. Additionally, participants will be given booklets to guide them in self-managing similar exercises at home, mirroring the home program of the self-management group.

on-site task-related group

on-line self-management training BEHAVIORAL

To encourage adherence to the home program among early-stage Parkinson's disease participants, the investigators have developed various self-management topics, including medication adherence and exercise benefits. The home program is categorized into two dimensions: daily function and exercise. The investigators will provides participants with detailed guidelines to ensure safe execution of the program independently.

on-line self-management group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to sign the informed consent form.
• Age between 45 and 70 years, with mild idiopathic Parkinson's disease and Hoehn and Yahr stage 1-2.
• No cognitive impairment.
• No severe depression that could affect the motivation to participate in the study.
• No history of shoulder dislocation or fracture that could affect body proprioception.
• No diseases that could affect the ability to reach for objects, such as stroke.
• No diseases that could affect peripheral sensation, such as diabetes.
• No severe tremors; patients whose hands, when relaxed and placed on the apparatus, still exhibit significant tremor interfering with the experiment will not be included.
• Able to follow instructions and complete the assessment process.
• Have not received physical or occupational therapy in the past year.

You may not qualify if:

• Other central nervous system diseases, such as stroke.
• Have major surgery on the head or upper limbs.
• Inability to perform the reaching task while sitting.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung Memorial Hospital

Linkou District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kuan-yi Li, PhD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuan-yi Li, PhD

CONTACT

+886 32118800; kyli@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 8, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)