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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorChang Gung University

About this trial

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. 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. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: on-line self-management groupExperimental treatment 1 intervention
Group B: on-site task-related groupExperimental treatment 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
2

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.

Time frame
Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
3

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.

Time frame
Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
4

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.

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

Secondary outcomes

1

Time up and go test (TUG)

The change from baseline in mobility will be measured by the time taken as recorded. Before the test, the examinee sits steadily, readying for the test. Upon the examiner's cue, they stand from the chair and walk three meters, then turn, and sit back down. This duration is timed with a stopwatch by the examiner. To ensure accuracy, the test is repeated three times, averaging the times. The Timed Up and Go test serves as a swift, practical method for assessing functional mobility and pinpointing those at heightened fall risk or needing additional balance or gait training.

Time frame
Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
2

Grip Strength measure

The change from baseline in grip strength will be measured by the mean values to the norm according to participant's age and gender. The participant should sit with their upper arms naturally hanging down and their elbows bent at a 90-degree angle. Then, the participant should measure their grip strength three time, and the average of the three measurements should be analyzed.

Time frame
Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
3

Pinch Strength measure

The change from baseline in pinch grip will be measured by the mean values to the norm according to participant's age and gender. The participant should sit with their upper arms naturally hanging down and their elbows bent at a 90-degree angle. Then, the participant should measure their lateral /key pinch and palmar /three-jaw chuck pinch strength three times each, and the average of the three measurements for each method should be analyzed.

Time frame
Baseline (before intervention), week 6 (after intervention), follow-up (6 months after intervention)
4

Hand length measure

Hand length is measured at baseline to provide information for adjusting the value of strength during statistical analysis. To measure the length of the hand, ask the participant to place their palm flat and facing up, and then measure the distance from the tip of the middle finger to the wrist crease.

Time frame
Baseline (before intervention)

Other outcomes

1

Mini-Mental Status Examination (MMSE)

To ensure participants do not have dementia or other cognitive impairments. The scale consists of 20 questions and 30 items, including orientation, memory, attention and calculation, recall, and language ability. Each correct answer is scored 1 point, and incorrect or unanswerable questions are scored 0 points. The total score ranges from 0 to 30 points. Lower score indicates more severe cognitive impairment.

Time frame
Screening-before intervention (one of the inclusive criteria)
2

Beck depression scale

The objective is to confirm that study participants do not suffer from severe depression. Should severe depression be detected in a potential participant, they will be excluded from recruitment. The scale consists of 21 questions and 30 items, with a total score of 63 points. A score of 14-19 indicates mild depression, 20-28 indicates moderate depression, and 29 or higher indicates severe depression.

Time frame
Screening-before intervention (one of the inclusive criteria)

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