The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke
2015年10月5日 更新者:Michael Ellis、Northwestern University
Disturbances in movement coordination are the least well understood but often the most debilitating with respect to functional recovery following stroke.
These deficits in coordination are expressed in the form of abnormal muscle synergies and result in limited and stereotypic movement patterns that are functionally disabling.
The result of these constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an individual with stroke when they lift up the weight of the impaired arm against gravity.
The investigators previous neurotherapeutic research, supported by a NIDRR Field Initiated research grant, has shown that the abnormal synergy between shoulder abduction and elbow flexion can be significantly reduced thus increasing total reaching range of motion in individuals with severe stroke.
The previous work established progressive abduction loading as a key element to the rehabilitation of reaching.
Although individuals with severe stroke benefited from the investigators previous work, residual flexion synergy continued to hinder normal arm function in most participants with severe stroke.
This study will utilize the ACT3D robot, developed as part of the investigators previous NIDRR project, to incorporate resistance to reaching while accounting for the known benefits of progressive abduction loading.
The investigators propose to randomize forty participants with severe stroke into two closely related interventions.
The groups will both practice reaching under abduction loading, however, the experimental group will also move against resistance while reaching.
Rigorous and quantitative investigation of therapeutic elements such as resistance to reaching and progressive abduction loading is only possible with a device such as the ACT3D.
the investigators will be able to standardize the delivery of each intervention using kinematic and kinetic parameters, which will allow for a clear identification of the therapeutic effect of resistance to reaching.
the investigators hypothesize that resistance to reaching in combination with progressive abduction loading will further increase dynamic multi-joint strength, increase total reaching range of motion, and increase arm function thus enhancing actual amount of use of the arm, participation in life roles, and quality of life in individuals with severe stroke.
調査の概要
研究の種類
介入
入学 (実際)
38
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
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Illinois
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Chicago、Illinois、アメリカ、60611
- Department of Physical Therapy and Human Movement Sciences
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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
21年~85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:
- Paresis confined to one side, with substantial motor impairment of the upper limb
- Absence of motor impairment in the unimpaired limb
- Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment, changes in management of hypertension)
- Absence of any acute or chronic painful condition in the upper extremities or spine
- Absence of hemineglect
- Capacity to provide informed consent.
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:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Viscous Resistance & Abduction Loading
The intervention for the experimental group entails practicing reaching utilizing the robotic device, ACT3D, with the experimental element of horizontal viscosity in combination with abduction loading.
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All participants will undergo 8 weeks of reaching practice in the ACT3D.
Frequency and duration will be matched at three 1.5-hour sessions per week.
All reaching practice will include abduction (gravity) loading standardized to the participant's motor abilities.
The experimental group intervention will also include a horizontal viscous resistant element similar to pushing the arm through molasses.
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アクティブコンパレータ:Abduction Loading
The intervention for the active comparison group entails practicing reaching utilizing the robotic device, ACT3D, with only abduction loading.
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All participants will undergo 8 weeks of reaching practice in the ACT3D.
Frequency and duration will be matched at three 1.5-hour sessions per week.
All reaching practice will include abduction (gravity) loading standardized to the participant's motor abilities.
The experimental group intervention will also include a horizontal viscous resistant element similar to pushing the arm through molasses.
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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 |
|---|---|---|
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Change in Peak Endpoint Reaching Velocity
時間枠:Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
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We will quantify peak endpoint reaching velocity with a robotic device, ACT3D, when a participant with stroke reaches as fast as they can toward an outward target under various abduction (gravity) loading conditions.
This measure will serve as the primary measure for changes in dynamic multi-joint strength.
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Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
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Change in Reaching Work Area
時間枠:Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
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We will quantify total reaching work area (combined shoulder and elbow range of motion) with a robotic device, ACT3D, under various abduction (gravity) loading conditions.
This measure will serve as the primary measure changes in dynamic multi-joint range of motion.
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Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Fugl-Meyer Motor Assessment
時間枠:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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Qualitative and clinical assessment of general motor impairment of arm following stroke.
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Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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Rancho Los Amigos Functional Test for the Hemiparetic Upper Extremity
時間枠:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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Qualitative and clinical assessment of activity limitation (function) of the arm following stroke.
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Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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Stroke Impact Scale
時間枠:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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Structured interview to assess all domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke.
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Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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Motor Activity Log
時間枠:Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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Structured interview assessing the individual with stroke's perception of difficulty in the context of arm function during a variety of activities of daily living.
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Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
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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。
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
- Sukal TM, Ellis MD, Dewald JP. Shoulder abduction-induced reductions in reaching work area following hemiparetic stroke: neuroscientific implications. Exp Brain Res. 2007 Nov;183(2):215-23. doi: 10.1007/s00221-007-1029-6. Epub 2007 Jul 20.
- Ellis MD, Sukal-Moulton T, Dewald JP. Progressive shoulder abduction loading is a crucial element of arm rehabilitation in chronic stroke. Neurorehabil Neural Repair. 2009 Oct;23(8):862-9. doi: 10.1177/1545968309332927. Epub 2009 May 19.
- Ellis MD, Sukal T, DeMott T, Dewald JP. Augmenting clinical evaluation of hemiparetic arm movement with a laboratory-based quantitative measurement of kinematics as a function of limb loading. Neurorehabil Neural Repair. 2008 Jul-Aug;22(4):321-9. doi: 10.1177/1545968307313509. Epub 2008 Mar 8.
- Ellis MD, Acosta AM, Yao J, Dewald JP. Position-dependent torque coupling and associated muscle activation in the hemiparetic upper extremity. Exp Brain Res. 2007 Feb;176(4):594-602. doi: 10.1007/s00221-006-0637-x. Epub 2006 Aug 22.
- Ellis MD, Holubar BG, Acosta AM, Beer RF, Dewald JP. Modifiability of abnormal isometric elbow and shoulder joint torque coupling after stroke. Muscle Nerve. 2005 Aug;32(2):170-8. doi: 10.1002/mus.20343.
- Ellis MD, Carmona C, Drogos J, Dewald JPA. Progressive Abduction Loading Therapy with Horizontal-Plane Viscous Resistance Targeting Weakness and Flexion Synergy to Treat Upper Limb Function in Chronic Hemiparetic Stroke: A Randomized Clinical Trial. Front Neurol. 2018 Feb 19;9:71. doi: 10.3389/fneur.2018.00071. eCollection 2018.
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
2012年3月1日
一次修了 (実際)
2015年7月1日
研究の完了 (実際)
2015年7月1日
試験登録日
最初に提出
2012年2月29日
QC基準を満たした最初の提出物
2012年3月5日
最初の投稿 (見積もり)
2012年3月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月6日
QC基準を満たした最後の更新が送信されました
2015年10月5日
最終確認日
2015年10月1日
詳しくは
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。