Interactive POWER Rehabilitation System on Rehabilitation Training for Patients With Parkinson's Disease

NCT05046236 | Unknown DMC

• 1 other identifier: 2021-05-004A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

In the previous studies, progressive resistance training (PRT) has significantly improved the muscle strength and disease severity of Parkinson's disease. However, there is currently no consensus on the impact of PRT on physical function such as balance and walking ability for Parkinson's patients. Therefore, this study focuses on developing a visual feedback system added to the original POWER rehabilitation system, and to investigate whether the training through this "interactive POWER rehabilitation system" can produce the clinical benefits, as well as improving the daily life of patients with Parkinson's disease.

Conditions

Parkinson Disease

Keywords

Interactive POWER rehabilitation; Applications; Data analysis; Laser sensors; Parkinson's disease; Machine learning; Physical function; Exercise intervention; Activities of daily living; Functional training; Quality of life

Outcome Measures

Primary Outcomes (11)

• Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks

  A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale".The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points. The higher score meand the worse condition. The sum of all the items'score is the score of the scale. Higher Rating Scales'scores indicate severe symptoms.

  Baseline and post-intervention at 12 weeks

• Change from Baseline he Parkinson's Disease Questionnaire (PDQ-39) at 12 weeks

  The 39-point PDQ provides scores for each of the 8 scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort. It is used to assess the overall health-related quality of life profile of the individual questioned.

  Baseline and post-intervention at 12 weeks

• Change from Baseline the Mini-Mental State Exam (MMSE) at 12 weeks

  A widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.

  Baseline and post-intervention at 12 weeks

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

  A simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

  Baseline and post-intervention at 12 weeks

• Change from Baseline Mini-BESTest at 12 weeks

  The scale includes four items: (1) anticipatory balance, (2) reactive posture control, (3) sensory orientation, and (4) dynamic gait, A total of 14 measurement items, 2 points for each question, a total of 28 points.

  Baseline and post-intervention at 12 weeks

• Change from Baseline six minute walk test (6MWT) at 12 weeks

  Walk for six minutes at the subject's preferred speed and assistive devices. You can stop at any time in the middle. After the end, the walking distance will be recorded, and changes in heartbeat, blood pressure, blood oxygen saturation, dyspnea and fatigue will be monitored. It will also end at the end then evaluate the walking distance.

  Baseline and post-intervention at 12 weeks

• Change from Baseline muscle strength of upper limbs at 12 weeks

  Use a hand-grip dynamometer to test the grip strength. Both hands need to be measured twice individually, with a rest time of at least 30 seconds between the two.

  Baseline and post-intervention at 12 weeks

• Change from Baseline muscle strength of lower limbs at 12 weeks

  Use Micro FET3 instrument to measure knee joint extension and flexion; hip joint abduction and flexion muscle strength. Each muscle group needs to be tested twice, with a 30-second rest between the two, and two recordings Take the maximum value afterwards.

  Baseline and post-intervention at 12 weeks

• Change from Baseline gait Speed at 12 weeks

  The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up, including the following lists. Stopwatch will also be employed by the operator to measure the walking time simultaneously. \- Speed (m/s): Mean walking stride velocity of forward walking

  Baseline and post-intervention at 12 weeks

• Change from Baseline cadence at 12 weeks

  The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up. \- Cadence (step/minute): Number of steps in a minute

  Baseline and post-intervention at 12 weeks

• Change from Baseline stride length at 12 weeks

  The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up. \- Stride length (m): Distance between two consecutive footprints on the ground

  Baseline and post-intervention at 12 weeks

Study Arms (3)

Interactive POWER rehabilitation

EXPERIMENTAL

Participants in this group would be treated with POWER for twice a week, total 12 weeks.

Other: Interactive POWER rehabilitation

Conventical physical training Group

ACTIVE COMPARATOR

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

Other: Conventical physical training

Control group

NO INTERVENTION

Usual care

Interventions

Interactive POWER rehabilitation OTHER

Interactive POWER rehabilitation training for twice a week, total 12 weeks, that consisted of 6 types of equipment for strength training.

Interactive POWER rehabilitation

Conventical physical training OTHER

Conventional physical training models in current clinical use for twice a week, total 12 weeks, that consisted of strength training, balance training, stretching, gait training, and etc.

Conventical physical training Group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Volunteer (can walk 15 meters independently or with assistive devices).
• Aged 20-70 years old.
• Mini-mental state examination (MMSE) points above 24.
• Not familiar with POWER rehabilitation machines before this study.
• Able to understand POWER rehabilitation training and test items.
• Able to use smart devices and be willing to cooperate with pre-acceptance instructions.
• Able to communicate in Mandarin or Taiwanese, and be able to clearly express uncomfortable feelings.
• Willing to participate in this study after explanations, and sign the subject's informed consent.
• Diagnosed as Idiopathic Parkinsonism by Neurologist
• PD stages of I-III according to the modified Hoehn and Yahr Scale
• Aged 45-85 years old
• Mini-mental state testing (MMSE) 24 points or more
• Stable medication regimen for at least 2 weeks before the trial
• Can walk 15 meters independently or with devices
• Able to understand treatment and assessment

You may not qualify if:

• People who do not use smart devices and are unwilling to cooperate with the pre-acceptance instructions.
• Have severe hearing or vision impairments.
• Pregnant or breast-feeding.
• Any chronic condition that may cause safety concerns.
• Having any diseases which are contraindications for exercise participation.
• Muscle strength is affected by taking drugs.
• Have been to the gym 6 months before participating in the study (e.g. aerobic exercise, resistance training).
• Severe orthopedic diseases (unhealed fractures, severe joint destructions, and joints with fixed deformities, etc.).
• Severe or unstable neurological or cardiopulmonary diseases (severe cases of stroke and myocardial infarction in the acute phase, arrhythmia or uncontrolled blood pressure, etc.).
• Diagnosed with any mental illness (e.g., depression, psychosis or other mental illnesses)
• Unwilling to participate in this research.
• Rheumatism
• Cardiovascular diseases or respiratory diseases (e.g., angina pectoris, pulmonary embolism, etc.)
• Severe or unstable neurological or orthopedic diseases.
• Severe hearing or vision impairments

Sponsors & Collaborators

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

Study Sites (2)

Far Eastern memorial hospital

New Taipei City, 220, Taiwan

RECRUITING

Taipei Veterans General Hospital

New Taipei City, Taiwan

RECRUITING

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

Study Officials

• Si-Huei Lee, PhD

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

Szu-Min Fu, Student

CONTACT

886-982202892; szuminfu.be09@nycu.edu.tw

Wei-Di Chen, Student

CONTACT

886-966070329; wdcdino0329.be09@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

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 16, 2021
• Study Start: October 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)