Clinical trial NCT06888869: Interactive Home-based Rehabilitation Exercise Assessment Platform and Exploration of Clinical Effects in Patients with Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
visual feedback
Exercise intervention
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2025-03-21
Enrollment: 92
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with primary Parkinson's disease by a neurologist
2. Modified Hoehn and Yahr Scale I-III
3. Aged 45-85 years old
4. Mini-Mental State Examination (MMSE) score of 24 or above
5. Stable on Parkinson's disease-related medications
6. Able to walk independently or use assistive devices to walk 15 meters
7. Able to understand the movements and test items
8. Able to understand and willing to sign the informed consent form

Exclusion Criteria:

1. Rheumatic diseases
2. Unstable heart and respiratory diseases (such as angina pectoris, pulmonary embolism, etc.)
3. Severe or unstable neurological or orthopedic diseases (such as stroke, dementia, fractures, etc.)
4. Severe hearing or visual impairment, unable to cooperate with researchers
5. People diagnosed with mental illness
6. People with a history of epilepsy or a direct blood relative with a history of epilepsy
7. Pregnant or breastfeeding women
8. People with any uncontrolled chronic diseases that may cause safety concerns
9. People living without family members or case caregivers.

Primary outcomes:
measure: Change from Baseline Timed Up and Go test (TUG) at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline muscle strength of upper limbs at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline muscle strength of lower limbs at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline gait Speed at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline the Mini-Mental State Exam (MMSE) at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline Quality of Life Scale(PDQ39) at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline technology acceptance forms at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline The unified Parkinson's disease rating scale(UPDRS) at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline IPAQ Taiwan Activity Survey at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
measure: Change from Baseline Six-minute walk distance at 12 weeks
timeFrame: pre-test(first time) and post-test(after 12 weeks)
Secondary outcomes:
Other outcomes:
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