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Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation

2019年12月9日 更新者:Lai chien hung、Taipei Medical University Hospital

Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke

This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty participants will be recruited in this study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).

調査の概要

詳細な説明

Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study. All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before and after intervention in all participants.

研究の種類

介入

入学 (予想される)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Taipei、台湾
        • 募集
        • Taipei Medical University Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年~80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
  2. Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
  3. Participants are stable in medical and psychological condition.

Exclusion Criteria:

  1. Participants have other neurologic problems that can affect balance and walking ability.
  2. Participants take of drugs or have other medical condition that can affect balance and function.
  3. Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:rTMS and AR group
Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
アクティブコンパレータ:Sham rTMS and AR group
Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
アクティブコンパレータ:AR group
Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
アクティブコンパレータ:Conventional physiotherapy group
Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change of Time Up Go test (TUG)
時間枠:Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
The TUG test will ask participants to stand up, walk for 3 m, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups

二次結果の測定

結果測定
メジャーの説明
時間枠
Change of Berg Balance Scale (BBS)
時間枠:Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Motor evoked potential (MEP)
時間枠:Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
時間枠:Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Multi-directional Reach Test (MDRT)
時間枠:Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Participants will be required to reach in the forward, left and right directions. The test is performed with the participant in standing. It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support. The test uses a centimeters measuring device against a wall at shoulder height.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of The Postural Assessment Scale for Stroke Patients (PASS)
時間枠:Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36. A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 36.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Taiwanese Depression Questionnaires (TDQ)
時間枠:Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week. The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". Zero denotes never, three means always. TDQ scores range from 0 to 54.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年7月31日

一次修了 (予想される)

2020年10月30日

研究の完了 (予想される)

2020年12月30日

試験登録日

最初に提出

2018年11月20日

QC基準を満たした最初の提出物

2018年11月20日

最初の投稿 (実際)

2018年11月23日

学習記録の更新

投稿された最後の更新 (実際)

2019年12月11日

QC基準を満たした最後の更新が送信されました

2019年12月9日

最終確認日

2019年12月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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rTMS and ARの臨床試験

3
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