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Correlation Between Music Therapist's and Stroke Patient's Engagement Levels and Patient's Fingers and Wrist Movement

2022年1月10日 更新者:Avi Ohry、Reuth Rehabilitation Hospital

Correlation Between EEG Based Assessment of Music Therapist and Stroke Patient's Engagement and Patient's Fingers and Wrist Movement During Music Therapeutic Interaction Versus Verbal Interaction - A Pilot and Feasibility Study

Background: Fingers and wrist functional impairments are common among stroke patients. The patient's engagement, their therapist's engagement, and the patient-therapist interaction during therapy, contribute significantly towards better outcomes in rehabilitation. Music therapeutic interaction between patient and music therapist, which involves active music-making, can enhance a stroke patient's engagement and improve fingers and wrist movement of the affected hand.

Study Objectives: 1. To assess the correlation between the therapist engagement's levels, patient engagement's levels, and patient's fingers and wrist movement. 2. To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction. 3. To determine if the changes to patients' fingers and wrist movement differ during a music therapeutic Interaction session when compared with a verbal interaction session.

Methods: This feasibility pilot study will include 10 patients, with right-sided hemiparesis who will be recruited 1-6 months following stroke. Each subject will participate in 2 sessions: verbal interaction session and music interactions session conducted both by the same qualified music therapist. For both sessions, each participant will be asked to perform three musical exercises with their right hand on an electric piano. During the Verbal Interaction session, participants will perform exercises alone, while the therapist only interacts with them verbally. During the second session, the Music Therapeutic Interaction session, participants will perform musical exercises while the therapist is interacting with them musically, using music therapy techniques. Measurement tools will include an EEG marker - the Cognitive Effort Index (CEI), for real-time measurement of the patient's and therapist's level of engagement; the HandTutorTM for evaluating real-time changes in a patient's fingers and wrist movement; and video recordings of the patient's hands while performing the musical exercises.

調査の概要

詳細な説明

Background: Fingers and wrist functional impairments are common among stroke patients. The patient's engagement, their therapist's engagement, and the patient-therapist interaction during therapy, contribute significantly towards better outcomes in rehabilitation. Music therapeutic interaction between patient and music therapist, which involves active music making, can enhance a stroke patient's engagement and improve fingers and wrist movement of the affected hand.

Study Objectives:

  1. To assess the correlation between the therapist engagement's levels, patient engagement's levels and patient's fingers and wrist movement.
  2. To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction.
  3. To determine if the changes to patients' fingers and wrist movement differ during a music therapeutic Interaction session when compared with a verbal interaction session.

Methods

Participants:

Post stroke rehabilitation patients with right hemiparesis (n=10), recruited 1-6 months following stroke from Reuth Rehabilitation hospital.

Recruitment process:

The research team will screen patients' records on a daily basis to identify potentially eligible participants. Eligible patients will be invited by the research coordinator to participate in the study. After obtaining informed consent the researcher will meet them for an intake.

Sample size:

Based on Reuth's electronic medical records, with the assumption that some of the eligible patients will not agree to participate, for this feasibility study a convenience sample of 10 patients will be recruited within two months. Outcome data will be utilized to inform a sample size calculation for the larger study.

Study design and procedures

This is an intervention study that compares Verbal Interaction to Music Therapeutic Interaction. Each subject will participate in both sessions and will act as their own control, enabling between and within subject comparisons. There will be a two day washout period between the sessions for each patient, to prevent carryover effects. To minimize the between and within subject variance, the sequence of both sessions, including the order of the three musical exercises within each session, will be the same for all study participants. Both sessions will be delivered by the same qualified music therapist with vast clinical experience working with stroke patients in a neurorehabilitation setting. During both sessions, the therapist and the patient will each be wearing single-channel EEG devices to monitor engagement, via the Cognitive Effort Index (CEI) (Neurosky MindWave). Additionally, patients will be wearing a fingers and wrist movement monitoring device on their right affected hand, via the HandTutorTM (MediTouch, Ltd.). Within each session the music therapist's engagement level, the patient's engagement level, and the patient's real-time fingers and wrist movement will be measured.

Finally, video recordings of the patient's hands while performing the musical exercises during both interventions will be used to synchronize between the CEI and the HandTutorTM glove.

研究の種類

介入

入学 (実際)

4

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

      • Tel Aviv、イスラエル、6902732
        • Reuth Rehabilitation 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

55年歳以上 (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. Age 55 and above.
  2. Ability to understand and speak Hebrew.
  3. First CVA (ischemic or hemorrhagic) with right side hemiparesis
  4. Hand dominance: Right.
  5. With sufficient autonomy in motor functions of upper limbs in order to use musical instruments.
  6. Cognition: Mini-Mental State Examination >24 or MoCA Test>26.
  7. No previous musical education.

Exclusion Criteria:

  1. History of or current neurological or psychiatric disease.
  2. Aphasia or amusia.

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:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
他の:Single arm study with two interventions
Single arm where each participant will undergo two interventions in the following order: Verbal Interaction and Music Therapeutic Interaction. Both interactions will be conducted by the same music therapist.
In both sessions (the Verbal Interaction and the Music Therapeutic Interaction) participants will be asked to perform three piano playing exercises in a fixed order: (1) playing a musical scale, (2) playing a short excerpt from a familiar song, and (3) free improvisation. Both sessions will also include a protocol of verbal instructions given by the therapist before each exercise. In session A ('Verbal Interaction') participants will perform these exercises alone while the therapist is only interacting with them verbally (asking them questions, commenting regarding their performance etc.). In session B ('Music Therapeutic Interaction') participants will perform these exercises while the therapist is interacting with them musically, using various music therapy techniques that are matched and attuned to each patient's playing dynamics and style. This is to reflect the dynamics of the music therapeutic interaction as it occurs in the "real world" of music therapy practice.

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
Patient's engagement
時間枠:2 sessions, 30-minutes each
Cognitive Effort Index (CEI) (Neurosky MindWave) - An easy to use EEG marker for attention which provides a real-time measurement of the patient's and therapist's engagements' levels throughout the session. The CEI data is sampled using a dry electrodes system, with one frontal electrode and one reference electrode on the earlobe. The sampled data is transferred through a wireless connection to a computer, where the data is processed and the CEI marker is generated every 10 seconds and presented by the CEI monitor. The CEI level of engagement appears within the scale of 0-1. During both conditions the patient and the therapist will not have sight of the CEI monitor.
2 sessions, 30-minutes each
Therapist's engagement
時間枠:2 sessions, 30-minutes each
As described in the 'Patient's engagement' section
2 sessions, 30-minutes each
Patient's fingers and wrist movement
時間枠:2 sessions, 30-minutes each
HandTutorTM (MediTouch, Ltd.) - Will be used for real-time measuring of a patient's fingers and wrist movement. It includes an ergonomic glove with sensors which enables the patient's fingers and wrist movement to be monitored on a computer screen. This glove provides continuous feedback on range, speed and quality of the movement during the session. In both sessions the patient will be wearing one glove on his right affected hand. Prior to each exercise, there will be a baseline evaluation of the patient's fingers and wrist's active range of motion. These values will be the basis for the comparison of changes in patients' fingers and wrist range of motion during each of the exercises.
2 sessions, 30-minutes each

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。

捜査官

  • 主任研究者:Avi Ohry, M.D、Reuth Rehabilitation Hospital, Tel-Aviv, Israel

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)

2021年7月15日

一次修了 (実際)

2022年1月9日

研究の完了 (実際)

2022年1月9日

試験登録日

最初に提出

2021年8月16日

QC基準を満たした最初の提出物

2021年8月16日

最初の投稿 (実際)

2021年8月18日

学習記録の更新

投稿された最後の更新 (実際)

2022年1月26日

QC基準を満たした最後の更新が送信されました

2022年1月10日

最終確認日

2022年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 0010-21-RRH

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いいえ

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いいえ

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