Parkinson DiseasePDNCT06888869
Interactive Home-based Rehabilitation Exercise Assessment Platform and Exploration of Clinical Effects in Patients with Parkinson's Disease
A study testing Other: Clinical rehabilitation group and Other: Home-based rehabilitation group in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
This study aims to develop an "Interactive Home-based Rehabilitation Exercise Assessment Platform" that incorporates visual feedback similar to virtual reality into rehabilitation machines and aerobic cycling programs. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Other: Clinical rehabilitation group and Other: Home-based rehabilitation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with primary Parkinson's disease by a neurologist
- Modified Hoehn and Yahr Scale I-III
- Aged 45-85 years old
- Mini-Mental State Examination (MMSE) score of 24 or above
- Stable on Parkinson's disease-related medications
- Able to walk independently or use assistive devices to walk 15 meters
- Able to understand the movements and test items
- Able to understand and willing to sign the informed consent form
Who cannot join
- Rheumatic diseases
- Unstable heart and respiratory diseases (such as angina pectoris, pulmonary embolism, etc.)
- Severe or unstable neurological or orthopedic diseases (such as stroke, dementia, fractures, etc.)
- Severe hearing or visual impairment, unable to cooperate with researchers
- People diagnosed with mental illness
- People with a history of epilepsy or a direct blood relative with a history of epilepsy
Show all 9Show fewer
- Pregnant or breastfeeding women
- People with any uncontrolled chronic diseases that may cause safety concerns
- People living without family members or case caregivers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Development and Verification of an Interactive Home-based Rehabilitation Exercise Assessment Platform and Exploration of Technology Acceptance and Clinical Effects in Patients with Parkinson's Disease
This study aims to develop an "Interactive Home-based Rehabilitation Exercise Assessment Platform" that incorporates visual feedback similar to virtual reality into rehabilitation machines and aerobic cycling programs. In the clinical research part, 92 Parkinson's disease patients will be randomly assigned to three groups: the clinical rehabilitation group, the home-based rehabilitation group, and the control group. Each group will undergo the intervention twice a week, with each session lasting about 30-45 minutes over a period of 12 weeks for a total of 24 combined resistance and aerobic rehabilitation training sessions. The effectiveness evaluation will include measurements of upper limb grip strength, lower limb muscle strength, the 3-meter sit-to-stand test, the 6-minute walk test, the Parkinson's Disease Severity Scale, the Quality of Life Scale, the 10-meter walk test, and technology acceptance forms.
Read the detailed description
Background and Purpose: Previous research on technological interventions in exercise therapy for Parkinson's disease has shown that incorporating visual feedback through virtual reality into rehabilitation exercise programs can improve patients' balance, muscle strength, gait, and other functional performances. This study aims to develop an "Interactive Home-based Rehabilitation Exercise Assessment Platform" that incorporates visual feedback similar to virtual reality into rehabilitation machines and aerobic cycling programs. The platform uses sensors and interactive games to guide correct rehabilitation movements. The effectiveness of the platform will be validated through engineering-related tests and clinical trials further to investigate its clinical benefits for Parkinson's disease patients.
Methods: This study consists of two parts: platform development and validation and clinical research. The platform will be implemented for use in medical institutions and at home, specifically at Taipei Veterans General Hospital, utilizing six rehabilitation machines and aerobic bicycles, as well as home-based cycling combined with resistance band training. Interactive game software and laser sensors will be developed. Sensors will collect patients' physiological parameters during the rehabilitation process to ensure safety and provide real-time feedback on movements and time control during the sessions. The collected data, including angle values, cycling revolutions, and physiological parameters, will be verified for usability using commercially available products.
In the clinical research part, 92 Parkinson's disease patients will be randomly assigned to three groups: the clinical rehabilitation group, the home-based rehabilitation group, and the control group. Each group will undergo the intervention twice a week, with each session lasting about 30-45 minutes over a period of 12 weeks for a total of 24 combined resistance and aerobic rehabilitation training sessions. The effectiveness evaluation will include measurements of upper limb grip strength, lower limb muscle strength, the 3-meter sit-to-stand test, the 6-minute walk test, the Parkinson's Disease Severity Scale, the Quality of Life Scale, the 10-meter walk test, and technology acceptance forms. Statistical analysis will be performed using one-way ANOVA and chi-square tests to analyze personal data characteristics. For clinical effectiveness analysis, a two-way (group by time) ANOVA with repeated measures will be used to examine differences between groups and over time, with Bonferroni tests for post-hoc comparisons. All data will be analyzed using SPSS version 24, with a p-value of less than 0.05, which is considered statistically significant.
- Conditions
- Parkinson Disease
- Being tested
- Other: Clinical rehabilitation group, Other: Home-based rehabilitation group
- Keywords
- Parkinson, visual feedback, Exercise intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Clinical rehabilitation groupOther
Rehabilitation training for twice a week, total 12 weeks in hospitals.
Other: Home-based rehabilitation groupOther
Rehabilitation training for twice a week, total 12 weeks at home.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Clinical rehabilitation | Experimental | Participants in this group would be treated with exercise rehabilitation for twice a week, total 12 weeks in the hospitals. Receives: Other: Other: Clinical rehabilitation group |
| Active Comparator: Home-based rehabilitation | Active comparator | Rehabilitation training for twice a week, total 12 weeks at home. Receives: Other: Other: Home-based rehabilitation group |
| No Intervention: Control | No intervention | The control group received Parkinson's disease treatment-related medication and was asked to maintain daily activities according to their usual lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Timed Up and Go test (TUG) at 12 weeks
The time score is lower, means the gait function is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline muscle strength of upper limbs at 12 weeks
The muscle strength of upper limbs score is higher, means the upper limbs is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline muscle strength of lower limbs at 12 weeks
The muscle strength of lower limbs score is higher, means the upper limbs is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline gait Speed at 12 weeks
The gait Speed time score is lower, means the gait function is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline the Mini-Mental State Exam (MMSE) at 12 weeks
The Mini-Mental State Exam score is higher, means the Cognitive function is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline Quality of Life Scale(PDQ39) at 12 weeks
Quality of Life Scale score is higher, means the Quality of Life is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline technology acceptance forms at 12 weeks
Technology acceptance forms score is higher, means theTechnology acceptance is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline The unified Parkinson's disease rating scale(UPDRS) at 12 weeks
The unified Parkinson's disease rating scale(UPDRS) score is lower, means Disease severity is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline IPAQ Taiwan Activity Survey at 12 weeks
No score in this IPAQ Taiwan Activity Survey form.
Measured: pre-test(first time) and post-test(after 12 weeks)
Change from Baseline Six-minute walk distance at 12 weeks
The Six-minute walk distance time score is lower, means walk distance is better.
Measured: pre-test(first time) and post-test(after 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start21 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Far Eastern Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888869
- Sponsor's protocol ID
- 2024-12-004A
- Acronym
- PD
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Verification of an Interactive Home-based Rehabilitation Exercise Assessment Platform and Exploration of Technology Acceptance and Clinical Effects in Patients with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06888869
- Acronym / sponsor ID
- PD / 2024-12-004A
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, visual feedback, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- 21 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop an "Interactive Home-based Rehabilitation Exercise Assessment Platform" that incorporates visual feedback similar to virtual reality into rehabilitation machines and aerobic cycling programs. In the clinical research part, 92 Parkinson's disease patients will be randomly assigned to three groups: the clinical rehabilitation group, the home-based rehabilitation group, and the control group. Each group will undergo the intervention twice a week, with each session lasting about 30-45 minutes over a period of 12 weeks for a total of 24 combined resistance and aerobic rehabilitation training sessions. The effectiveness evaluation will include measurements of upper limb grip strength, lower limb muscle strength, the 3-meter sit-to-stand test, the 6-minute walk test, the Parkinson's Disease Severity Scale, the Quality of Life Scale, the 10-meter walk test, and technology acceptance forms.
Detailed description
Background and Purpose: Previous research on technological interventions in exercise therapy for Parkinson's disease has shown that incorporating visual feedback through virtual reality into rehabilitation exercise programs can improve patients' balance, muscle strength, gait, and other functional performances. This study aims to develop an "Interactive Home-based Rehabilitation Exercise Assessment Platform" that incorporates visual feedback similar to virtual reality into rehabilitation machines and aerobic cycling programs. The platform uses sensors and interactive games to guide correct rehabilitation movements. The effectiveness of the platform will be validated through engineering-related tests and clinical trials further to investigate its clinical benefits for Parkinson's disease patients.
Methods: This study consists of two parts: platform development and validation and clinical research. The platform will be implemented for use in medical institutions and at home, specifically at Taipei Veterans General Hospital, utilizing six rehabilitation machines and aerobic bicycles, as well as home-based cycling combined with resistance band training. Interactive game software and laser sensors will be developed. Sensors will collect patients' physiological parameters during the rehabilitation process to ensure safety and provide real-time feedback on movements and time control during the sessions. The collected data, including angle values, cycling revolutions, and physiological parameters, will be verified for usability using commercially available products.
In the clinical research part, 92 Parkinson's disease patients will be randomly assigned to three groups: the clinical rehabilitation group, the home-based rehabilitation group, and the control group. Each group will undergo the intervention twice a week, with each session lasting about 30-45 minutes over a period of 12 weeks for a total of 24 combined resistance and aerobic rehabilitation training sessions. The effectiveness evaluation will include measurements of upper limb grip strength, lower limb muscle strength, the 3-meter sit-to-stand test, the 6-minute walk test, the Parkinson's Disease Severity Scale, the Quality of Life Scale, the 10-meter walk test, and technology acceptance forms. Statistical analysis will be performed using one-way ANOVA and chi-square tests to analyze personal data characteristics. For clinical effectiveness analysis, a two-way (group by time) ANOVA with repeated measures will be used to examine differences between groups and over time, with Bonferroni tests for post-hoc comparisons. All data will be analyzed using SPSS version 24, with a p-value of less than 0.05, which is considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: Clinical rehabilitation | Experimental | Other: Other: Clinical rehabilitation groupParticipants in this group would be treated with exercise rehabilitation for twice a week, total 12 weeks in the hospitals. |
| Active Comparator: Home-based rehabilitation | Active comparator | Other: Other: Home-based rehabilitation groupRehabilitation training for twice a week, total 12 weeks at home. |
| No Intervention: Control | No intervention | –The control group received Parkinson's disease treatment-related medication and was asked to maintain daily activities according to their usual lifestyle. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients diagnosed with primary Parkinson's disease by a neurologist
- Modified Hoehn and Yahr Scale I-III
- Aged 45-85 years old
- Mini-Mental State Examination (MMSE) score of 24 or above
- Stable on Parkinson's disease-related medications
Key exclusion criteria (9 listed)
- Rheumatic diseases
- Unstable heart and respiratory diseases (such as angina pectoris, pulmonary embolism, etc.)
- Severe or unstable neurological or orthopedic diseases (such as stroke, dementia, fractures, etc.)
- Severe hearing or visual impairment, unable to cooperate with researchers
- People diagnosed with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Clinical rehabilitation groupRehabilitation training for twice a week, total 12 weeks in hospitals. | Other | Experimental: Clinical rehabilitation |
| Other: Home-based rehabilitation groupRehabilitation training for twice a week, total 12 weeks at home. | Other | Active Comparator: Home-based rehabilitation |
Primary outcome
Change from Baseline Timed Up and Go test (TUG) at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
The time score is lower, means the gait function is better.
Change from Baseline muscle strength of upper limbs at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
The muscle strength of upper limbs score is higher, means the upper limbs is better.
Change from Baseline muscle strength of lower limbs at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
The muscle strength of lower limbs score is higher, means the upper limbs is better.
Change from Baseline gait Speed at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
The gait Speed time score is lower, means the gait function is better.
Change from Baseline the Mini-Mental State Exam (MMSE) at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
The Mini-Mental State Exam score is higher, means the Cognitive function is better.
Change from Baseline Quality of Life Scale(PDQ39) at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
Quality of Life Scale score is higher, means the Quality of Life is better.
Change from Baseline technology acceptance forms at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
Technology acceptance forms score is higher, means theTechnology acceptance is better.
Change from Baseline The unified Parkinson's disease rating scale(UPDRS) at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
The unified Parkinson's disease rating scale(UPDRS) score is lower, means Disease severity is better.
Change from Baseline IPAQ Taiwan Activity Survey at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
No score in this IPAQ Taiwan Activity Survey form.
Change from Baseline Six-minute walk distance at 12 weeks
Time frame: pre-test(first time) and post-test(after 12 weeks)
The Six-minute walk distance time score is lower, means walk distance is better.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Other: Clinical rehabilitation group and Other: Home-based rehabilitation group in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHEN WEI-DI PhD candidate (886-966070329, wdchen.be11@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Timed Up and Go test (TUG) at 12 weeks (time frame: pre-test(first time) and post-test(after 12 weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.