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

2022년 4월 1일 업데이트: Taipei Veterans General Hospital, Taiwan

Developing Visual Feedback-aided Power Rehabilitation System and Exploring Its' Applications on Rehabilitation Training for Patients With Parkinson's Disease

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Parkinson's disease (PD) is a progressive neurodegenerative disease of the central nervous system with complex etiology. This disease is related to the consumption of dopamine in the substantia nigra of the brain, and it is currently believed that the main factors of consumption of dopamine are (1) heredity (2) aging (3) environment.

At present, there are many rehabilitation treatments available for patients with Parkinson's disease, such as: progressive resistance training, yoga, Tai Chi, dancing, cognitive training, balance training, gait training, bicycle, and treadmill training, etc. During the recent years, the POWER rehabilitation system from Japan (Procedure Outcome Worthwhile for Elderly Rehabilitation, referred to as POWER rehabilitation) including six types of equipment for strengthening different body parts has been applied to frail elderly or neurological patients gradually.

Parkinson's patients are often considered to have major difficulties in responding to motion disturbances (inability to respond appropriately), leading to learning, insufficient attention and motivation problems. Therefore, maintenance of motivation and feedback on performance are key factors that affect the participation of exercises in patients with Parkinson's disease.

The application of virtual reality in patients with PD is becoming more and more effective. An integrated rehabilitation system can not only enable the clinicians to check the rehabilitation status during the treatment, but also provide feedbacks to the patient through the interactive visual feedback screen. For Parkinson's patients, providing visual feedback through virtual reality intervention may be of particular clinical value.

In the first phase of this study, a virtual reality-like visual feedback system will be developed and combined with the original "POWER rehabilitation system" to form the so-called "Interactive POWER Rehabilitation System", and then system verification will be carried out. In the second phase of this study, this newly developed system will be applied to the rehabilitation training for patients with Parkinson's disease, and to explore whether the combination of POWER rehabilitation with visual feedback can produce the clinical benefits, as well as improving the daily life of patients with PD. Patients will be randomly assigned into three groups: interactive POWER, functional training, and control group. Single blind data collection will be used. Patients will be evaluated at baseline and post 12-week interventions. Outcome measures will include mini-BESTest, Unified Parkinson's disease rating scale, muscle strength of upper and lower extremities, timed up and go, 6-minute walking test, gait, and Parkinson's disease questionnaire PDQ-39.

It is expected that the "Interactive POWER Rehabilitation System" can promote the learning ability of patients with Parkinson's disease by adding visual feedbacks and enhance the treatment effects. It also offer rehabilitation clinicians more treatment options, lower the administrative costs of supporting staffs, reduce commuting costs for the patients, and elevate patients' desire to comply with the treatment program.

연구 유형

중재적

등록 (예상)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 대만
      • New Taipei City, 대만, 220
        • 모병
        • Far Eastern Memorial Hospital
        • 연락하다:
          • Chao-Chun Huang, Bachelor
          • 전화번호: 866-2-77281501
      • New Taipei City, 대만
        • 모병
        • Taipei Veterans General Hospital
        • 연락하다:
          • Si-Huei Lee, PhD
          • 전화번호: 886-938591985

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria of phase I study

  1. Healthy Volunteer (can walk 15 meters independently or with assistive devices).
  2. Aged 20-70 years old.
  3. Mini-mental state examination (MMSE) points above 24.
  4. Not familiar with POWER rehabilitation machines before this study.
  5. Able to understand POWER rehabilitation training and test items.
  6. Able to use smart devices and be willing to cooperate with pre-acceptance instructions.
  7. Able to communicate in Mandarin or Taiwanese, and be able to clearly express uncomfortable feelings.
  8. Willing to participate in this study after explanations, and sign the subject's informed consent.

Inclusion Criteria of phase II study

  1. Diagnosed as Idiopathic Parkinsonism by Neurologist
  2. PD stages of I-III according to the modified Hoehn and Yahr Scale
  3. Aged 45-85 years old
  4. Mini-mental state testing (MMSE) 24 points or more
  5. Stable medication regimen for at least 2 weeks before the trial
  6. Can walk 15 meters independently or with devices
  7. Able to understand treatment and assessment
  8. Able to understand and be willing to agree to the informed consent form

Exclusion Criteria of phase I study

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

Exclusion Criteria of phase II study

  1. Rheumatism
  2. Cardiovascular diseases or respiratory diseases (e.g., angina pectoris, pulmonary embolism, etc.)
  3. Severe or unstable neurological or orthopedic diseases.
  4. Severe hearing or vision impairments
  5. Diagnosed with any mental illness(e.g., depression, psychosis or other mental illnesses)
  6. A history of epilepsy.
  7. Pregnancy or pregnancy
  8. Any uncontrolled disease.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 대조군
평소 케어
실험적: Interactive POWER rehabilitation
Participants in this group would be treated with POWER for twice a week, total 12 weeks.
다른: Interactive POWER rehabilitation
Interactive POWER rehabilitation training for twice a week, total 12 weeks, that consisted of 6 types of equipment for strength training.
활성 비교기: Conventical physical training Group
Participants in this group would be treated with traditional exercise rehabilitation for twice a week, total 12 weeks.
다른: Conventical physical training
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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
기간: Baseline and post-intervention 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Taipei Veterans General Hospital, Taiwan

협력자

Far Eastern Memorial Hospital

수사관

  • 연구 의자: Si-Huei Lee, PhD, Taipei Veterans General Hospital, Taiwan

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 10월 1일

기본 완료 (예상)

2022년 6월 30일

연구 완료 (예상)

2022년 8월 30일

연구 등록 날짜

최초 제출

2021년 7월 29일

QC 기준을 충족하는 최초 제출

2021년 9월 7일

처음 게시됨 (실제)

2021년 9월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 4월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 4월 1일

마지막으로 확인됨

2022년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2021-05-004A

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

파킨슨병에 대한 임상 시험

Interactive POWER rehabilitation에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Egypt

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다