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Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

2017年6月9日 更新者:Roger Gassert
The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.

調査の概要

研究の種類

介入

入学 (実際)

34

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

    • Ticino
      • Brissago、Ticino、スイス、6614
        • Clinica Hildebrand Centro di riabilitazione Brissago

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~90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:

  • age between 18-90 years old
  • hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
  • sub-acute lesion not more than 6 weeks post ictus

Exclusion Criteria:

  • insufficient state of consciousness
  • severe aphasia
  • severe cognitive deficits
  • severe pathologies of the upper extremity of traumatic or rheumatic nature
  • severe pain in the affected arm
  • Patients with pacemakers and other active implants

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:Robot group

Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy.

(4 x 45 min/week)

2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
他の名前:
  • Rehabilitation robot ReHapticKnob
アクティブコンパレータ:Control group
Receive dose-matched conventional neurocognitive therapy
Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g. discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
他の名前:
  • Perfetti-concept

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
Motor impairment of the upper limb
時間枠:Change from Baseline in motor impairment of the upper limb at 4 weeks
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 4 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Motor impairment of the upper limb
時間枠:Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb
時間枠:Change from Baseline in motor impairment of the upper limb at 6 months
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 6 months
Functional improvement in dexterity
時間枠:Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity
時間枠:Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity
時間枠:Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Spasticity level of the upper limb
時間枠:Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level of the upper limb
時間枠:Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level of the upper limb
時間枠:Change from Baseline in spasticity level of the upper limb at 6 months
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb
時間枠:Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Tactile and proprioceptive sensory function of the upper limb
時間枠:Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Tactile and proprioceptive sensory function of the upper limb
時間枠:Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Neglect
時間枠:Change from Baseline in neglect at 4 weeks
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 4 weeks
Neglect
時間枠:Change from Baseline in neglect at 8 weeks
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 8 weeks
Neglect
時間枠:Change from Baseline in neglect at 6 months
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 6 months
Cognitive impairment
時間枠:Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment
時間枠:Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment
時間枠:Change from Baseline in cognitive impairment at 6 months
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 6 months
Frontal lobe function
時間枠:Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function
時間枠:Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function
時間枠:Change from Baseline in frontal lobe function at 6 months
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 6 months
Aphasia
時間枠:Change from Baseline in aphasia at 4 weeks
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 4 weeks
Aphasia
時間枠:Change from Baseline in aphasia at 8 weeks
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 8 weeks
Aphasia
時間枠:Change from Baseline in aphasia at 6 months
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 6 months
Attention
時間枠:Change from Baseline in attention at 4 weeks
Attention is assessed with the test to identify attention
Change from Baseline in attention at 4 weeks
Attention
時間枠:Change from Baseline in attention at 8 weeks
Attention is assessed with the test to identify attention
Change from Baseline in attention at 8 weeks
Attention
時間枠:Change from Baseline in attention at 6 months
Attention is assessed with the test to identify attention
Change from Baseline in attention at 6 months

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

捜査官

  • スタディディレクター:Roger Gassert, Prof. Dr.、Rehabilitation Engineering Lab, ETH Zurich

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。

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)

2013年4月1日

一次修了 (実際)

2017年3月10日

研究の完了 (実際)

2017年6月9日

試験登録日

最初に提出

2014年3月19日

QC基準を満たした最初の提出物

2014年3月21日

最初の投稿 (見積もり)

2014年3月26日

学習記録の更新

投稿された最後の更新 (実際)

2017年6月12日

QC基準を満たした最後の更新が送信されました

2017年6月9日

最終確認日

2017年6月1日

詳しくは

本研究に関する用語

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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