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Effects of Training Rhythmic and Discrete Aiming Movements on Arm Control and Functionality After Stroke

2017年1月27日 更新者：Renata Morales Banjai、Universidade Cidade de Sao Paulo

Effects of Training Rhythmic and Discrete Aiming Movements on the Upper Limb Control and Functionality After Stroke: Randomized Controlled Trial

The purpose of this study is to verify the additional effects of rhythmic specific training, discrete specific training additional to conventional therapy on the upper limb after chronic stroke subjects on the outcomes: motor control and functionality.

調査の概要

状態

わからない

条件

介入・治療

詳細な説明

Seventy-five patients will be randomized into three groups to receive conventional therapy, consisting of a combination of mobility exercises joint, muscle stretching, strength training, motor coordination exercises, unilateral and bilateral motor tasks as well as oriented tasks training upper limb with a focus on functional tasks. The other groups will receive additional intervention consisting of aiming movement practice according two different protocols: discrete movements to targets placed in different directions and distances; and rhythmic movements also to targets placed in different directions and distances. Both additional interventional interventions will be conducted for 30 minutes over a 5 week-period (total: 10 sessions).

Clinical outcomes (motor control), functional and kinematic will be collected at baseline and at five weeks. Functional results will be collected at the beginning, after 5 weeks and 3 months after randomization. Data will be collected by a blinded assessor on patients' allocation group. All statistical analyzes will be carried out following the principles of intention to treat analysis and differences between groups will be performed using linear mixed models.

研究の種類

介入

入学 (予想される)

75

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

  • ブラジル
      • Sao Paulo、ブラジル、03071-000
        • 募集
        • Universidade Cidade de Sao Paulo
        • コンタクト：

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

18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:patients who participate in the survey, adult stroke survivors (>18 years), with primary diagnosis of first-ever unilateral stroke (ischaemic or haemorrhagic), stroke experienced > 6 months prior to study enrollment and score ≥ 20 on the Folstein Mini Mental Status Examination.

Exclusion criteria: patients with excessive pain in the paretic hand, arm or shoulder excessive spasticity at the paretic elbow and wrist as defined as a score of 4 on the Modified Ashworth Spasticity Scale and upper limb comorbidities that could limit their functional recovery (e.g., arthritis, pain, other neurological disorders).

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
アクティブコンパレータ：Conventional Physical Therapy
Usual therapy: joint mobility exercises, stimulating joint movement of the main active components of the upper limb; major muscle groups stretching, especially in the affected muscles by tone impairment; manual resistance training according to the degree of the patient's muscle strength, prioritizing the functional specificity of the upper limb, so the majority of the exercises will be held in open chain; motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks.
他の：Conventional Physical Therapy
Combination of joint mobility exercises, specific exercises for muscle strength and motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week)
実験的：discrete movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
他の：Discrete movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
実験的：rhythmic movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
他の：Rhythmic movement training group
Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.

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
Stroke Impact Scale (SIS)
時間枠：Five weeks after randomization and 3 months after randomization
Functionality: questionnaire which evaluates functionality. In this study will be evaluated four areas (arm muscle strength, hand function, activities of daily living and social participation)(Duncan et al., 1999). Each domain is scored from 1 to 5 (1 point corresponds to the worst possible outcome and 5 points to the best result). For the four areas the lowest possible score is 28 points and the highest is 125 points.
Five weeks after randomization and 3 months after randomization

二次結果の測定

結果測定
メジャーの説明
時間枠
Motor Activity Log (MAL)
時間枠：Five weeks and 3 months after randomization

Arm function: individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL) (Uswatte et al., 2005).

Items scored on a 6-point ordinal scale, where 0 corresponds to the weaker arm was not sued at all for that activity (never). Patients with a score 5 show the ability to use the weaker arm for that activity was as good as before the stroke (normal).
Five weeks and 3 months after randomization
Fugl-Meyer Assessment Scale
時間枠：Five weeks after randomization
Motor control: this scale assesses sensorimotor function of upper limb, with score 0-66 points with scores 0-66 points for motor function and 0-126 points for sensory-motor function (Fugl-Meyer, 1975). A higher score is better motor function.
Five weeks after randomization

その他の成果指標

結果測定
メジャーの説明
時間枠
kinematics assessment
時間枠：Five weeks after randomization
Functional capacity: It will be used an experimental apparatus that analyzes the motor behavior the aiming movement (Ribeiro et al., 2014). They will evaluate the movement time (measured in milliseconds), reaction time (in milliseconds) and smoothness (expressed in units of motion). The movement time is the time interval between the beginning and the end of the movement. Reaction time is defined as the time between the start of the imperative stimulus to the beginning of the movement. The smoothness is evaluated by computing the number of times the acceleration zero crossing (positive to negative and vice versa). The resultant variable error (in centimeters) is a measure of variability for both the medial-lateral direction as anteroposterior, assessing the accuracy to hit the target.
Five weeks after randomization
Grip strength
時間枠：Five weeks after randomization
Body function and structure: it will measure the strength of grip and pinch through dynamometer. The results will be presented in kilogram-force (Kgf) (Mathiowetz et al., 1985)
Five weeks after randomization
Modified Ashworth Spasticity Scale
時間枠：Five weeks after randomization
Body function and structure: they will be assessed flexors elbow, wrist and fingers, and forearm pronators. A measurement scale from 0 to 4 points, with 0 representing normal muscle tone and 4 is the highest possible degree of spasticity (Bohannon and Smith, 1987)
Five weeks after randomization

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。

スポンサー

Universidade Cidade de Sao Paulo

捜査官

  • スタディディレクター：Sandra R Alouche, PhD、Universidade Cidade São Paulo

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2016年6月1日

一次修了 (予想される)

2018年6月1日

研究の完了 (予想される)

2018年9月1日

試験登録日

最初に提出

2016年4月19日

QC基準を満たした最初の提出物

2016年5月3日

最初の投稿 (見積もり)

2016年5月6日

学習記録の更新

投稿された最後の更新 (見積もり)

2017年1月30日

QC基準を満たした最後の更新が送信されました

2017年1月27日

最終確認日

2017年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Universidade Cidade Sao Paulo

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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