Interactive Home-based Rehabilitation Exercise Assessment Platform and Exploration of Clinical Effects in Patients with Parkinson's Disease
NCT ID: NCT06888869
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
92 participants
INTERVENTIONAL
2025-03-21
2026-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: Clinical rehabilitation
Participants in this group would be treated with exercise rehabilitation for twice a week, total 12 weeks in the hospitals.
Other: Clinical rehabilitation group
Rehabilitation training for twice a week, total 12 weeks in hospitals.
Active Comparator: Home-based rehabilitation
Rehabilitation training for twice a week, total 12 weeks at home.
Other: Home-based rehabilitation group
Rehabilitation training for twice a week, total 12 weeks at home.
No Intervention: Control
The control group received Parkinson's disease treatment-related medication and was asked to maintain daily activities according to their usual lifestyle.
No interventions assigned to this group
Interventions
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Other: Clinical rehabilitation group
Rehabilitation training for twice a week, total 12 weeks in hospitals.
Other: Home-based rehabilitation group
Rehabilitation training for twice a week, total 12 weeks at home.
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
85 Years
ALL
No
Sponsors
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Far Eastern Memorial Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Central Contacts
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Other Identifiers
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2024-12-004A
Identifier Type: -
Identifier Source: org_study_id
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