Interactive Home-based Rehabilitation Exercise Assessment Platform and Exploration of Clinical Effects in Patients with Parkinson's Disease

NCT06888869 | Not Yet Recruiting DMC

• 1 other identifier: 2024-12-004A
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

Parkinson; visual feedback; Exercise intervention

Outcome Measures

Primary Outcomes (10)

• Change from Baseline Timed Up and Go test (TUG) at 12 weeks

  The time score is lower, means the gait function is better.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  pre-test(first time) and post-test(after 12 weeks)

Study Arms (3)

Experimental: Clinical rehabilitation

EXPERIMENTAL

Participants in this group would be treated with exercise rehabilitation for twice a week, total 12 weeks in the hospitals.

Other: Other: Clinical rehabilitation group

Active Comparator: Home-based rehabilitation

ACTIVE COMPARATOR

Rehabilitation training for twice a week, total 12 weeks at home.

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.

Interventions

Other: Clinical rehabilitation group OTHER

Rehabilitation training for twice a week, total 12 weeks in hospitals.

Experimental: Clinical rehabilitation

Other: Home-based rehabilitation group OTHER

Rehabilitation training for twice a week, total 12 weeks at home.

Active Comparator: Home-based rehabilitation

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant or breastfeeding women
• People with any uncontrolled chronic diseases that may cause safety concerns
• People living without family members or case caregivers.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Far Eastern Memorial Hospital: collaborator

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

Central Study Contacts

CHEN WEI-DI PhD candidate

CONTACT

886-966070329; wdchen.be11@nycu.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 GOV
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: March 21, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share