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Efficacy of Tele-CPASS Compared to In-person CPASS Therapy for Upper Extremity Motor Recovery

2026年6月16日 更新者:University of Texas, El Paso

Efficacy of Tele-CPASS, a Telerehabilitation Intervention Using Critical Periods After Stroke Study (CPASS) Compared to In-person CPASS for Upper Extremity Motor Recovery

This study evaluates whether a home-based telerehabilitation program (tele-CPASS) is as effective as an in-person rehabilitation program (CPASS) for improving arm and hand function after stroke. Stroke often leads to long-term difficulty using the affected arm in daily activities, and access to in-person therapy can be limited. This study aims to determine whether therapy delivered remotely can provide similar benefits to standard in-clinic care.

Participants who recently experienced a stroke will be randomly assigned to receive 20 hours of upper extremity rehabilitation therapy either in person or through a telehealth platform. Both groups will receive the same type and amount of therapy focused on practicing meaningful, patient-selected daily activities. Participants will complete assessments before treatment, immediately after treatment, and at 6 and 12 months to measure recovery of arm function, real-world arm use, and participation in daily life.

The results of this study will help determine whether telerehabilitation can improve access to effective stroke recovery interventions while maintaining clinical effectiveness comparable to in-person therapy.

調査の概要

詳細な説明

Stroke is a leading cause of long-term disability, with a substantial proportion of survivors experiencing persistent upper extremity impairment that limits independence in daily activities. While rehabilitation can improve outcomes, access to consistent, high-dose therapy remains a major barrier, particularly in the early months after stroke when recovery potential is highest. The Critical Periods After Stroke Study (CPASS) previously demonstrated that 20 hours of intensive, task-specific upper extremity training delivered within the first six months after stroke leads to clinically meaningful improvements in motor function compared to standard care.

Despite this evidence, many patients face challenges accessing in-person outpatient rehabilitation due to transportation limitations, cost, and geographic barriers. Telerehabilitation offers a potential solution by enabling delivery of structured therapy in the home environment. Prior studies suggest that home-based rehabilitation can achieve outcomes comparable to in-clinic care, while increasing accessibility and adherence. However, the efficacy of a telerehabilitation version of CPASS (tele-CPASS) relative to the established in-person CPASS intervention has not been rigorously tested.

This study is a randomized, controlled, parallel-group trial designed to evaluate whether tele-CPASS is comparable in efficacy to in-person CPASS for improving upper extremity recovery after stroke. Participants will be enrolled in the early post-stroke period and randomly assigned to one of two groups: (1) in-person CPASS delivered in a clinical setting, or (2) tele-CPASS delivered remotely in the participant's home using a secure telehealth platform. Both groups will receive the same total dose (20 hours) of therapist-guided, task-specific training over approximately 2-3 weeks. Therapy is individualized and based on patient-prioritized functional goals, emphasizing repetitive practice of meaningful daily activities.

Study procedures include baseline assessments followed by post-intervention and longitudinal follow-up assessments. In addition to standardized clinical evaluations, this study incorporates objective measurement of real-world arm use using wrist-worn accelerometers. These devices capture continuous movement data during daily life, allowing quantification of functional upper extremity use outside the clinical setting. A structured activity protocol performed in the laboratory and at home, combined with video annotation and machine learning methods, will be used to classify functional versus non-functional arm movements and enhance the ecological validity of outcome measurement.

The trial uses a non-inferiority framework to determine whether outcomes achieved with tele-CPASS are not meaningfully worse than those achieved with in-person CPASS. This approach is appropriate given prior evidence supporting the efficacy of the in-person intervention. Demonstrating comparable effectiveness would support tele-CPASS as a scalable and accessible model for delivering high-intensity stroke rehabilitation.

By directly comparing remote and in-person delivery of an evidence-based intervention, this study addresses a critical gap in stroke rehabilitation. If successful, tele-CPASS may expand access to effective therapy, reduce barriers to care, and inform future models of rehabilitation delivery that integrate clinic-based and home-based approaches.

研究の種類

介入

入学 (推定)

42

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。

研究連絡先

  • 名前:Dr. Shashwati Geed, PT, PhD
  • 電話番号:915-747-7289
  • メールsgeed@utep.edu

研究場所

    • Texas
      • El Paso、Texas、アメリカ、79902
        • 募集
        • Rehabilitation Sciences Complex, University of Texas at El Paso, 3333 N Mesa St, El Paso, TX 79902
        • コンタクト:
          • Shashwati Geed, PhD
          • 電話番号:915-747-7289
          • メールsgeed@utep.edu
      • El Paso、Texas、アメリカ、79905
        • 募集
        • Texas Tech University Health Sciences Center El Paso - Neurology Clinic
        • コンタクト:
          • Dr. Paisith Piriyawat, Medical Director, Rehabilitation Services, UMC-EP, MD
          • 電話番号:915-215-5900
          • メールPaisith.Piriyawat@ttuhsc.edu
        • コンタクト:
          • Israel Alba, MBA, CCRP
          • 電話番号:915-215-4616
      • El Paso、Texas、アメリカ、79905
        • 募集
        • University Medical Center of El Paso - Rehabilitation Services
        • コンタクト:
          • Dr. Paisith Piriyawat, Medical Director, Rehabilitation Services, UMC-EP, MD
          • 電話番号:915-215-5900
          • メールPaisith.Piriyawat@ttuhsc.edu

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age 21 years or older
  • Neuroimaging-confirmed stroke within 40 days prior to enrollment
  • Persistent hemiparesis resulting in impaired upper extremity function, defined by a score of 0 to 3 on the NIH Stroke Scale motor arm item
  • Able to participate in all study-related activities, including 1-year follow-up
  • Short Blessed Memory Orientation and Concentration Scale score less than 8
  • Able to follow 2-step commands
  • Montreal Cognitive Assessment (MoCA) score greater than 25
  • No upper extremity injury or condition that limited upper extremity use prior to the stroke

Exclusion Criteria:

  • Inability to provide informed consent
  • Persistent disabling neurologic condition, such as multiple sclerosis, Parkinsonism, amyotrophic lateral sclerosis, or dementia requiring medication
  • Clinically significant fluctuations in mental status within 72 hours prior to randomization
  • Active psychosis, psychosis within the prior 2 years, active substance abuse, or prior substance abuse
  • Dense sensory loss, defined by a score of 3 or 4 on the NIH Stroke Scale sensory item
  • Ataxia out of proportion to weakness in the affected arm, defined by a score greater than 1 on the NIH Stroke Scale ataxia item
  • Not expected to survive 12 months because of other illnesses
  • Pregnancy
  • Severe aphasia
  • Receipt of botulinum toxin or expectation of receiving botulinum toxin during the study period

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:Tele-CPASS
Participants receive 20 hours of therapist-guided upper extremity motor rehabilitation delivered remotely in the home using a telehealth platform. Therapy is individualized based on participant-prioritized activities and focuses on repetitive practice of meaningful daily tasks to improve arm and hand function after stroke.
Intervention 1: Tele-CPASS Tele-CPASS is a home-based telerehabilitation intervention consisting of 20 hours of therapist-guided, task-specific upper extremity motor training delivered remotely using a telehealth platform for individuals with stroke. Therapy is individualized based on participant-selected functional goals and focuses on repetitive practice of meaningful daily activities to improve arm and hand function after stroke. Participants complete sessions in their home environment with real-time therapist guidance and may be provided with equipment and technology needed to support remote delivery.
アクティブコンパレータ:In-person CPASS
Participants receive 20 hours of therapist-guided upper extremity motor rehabilitation delivered in person in the clinic. Therapy is individualized based on participant-prioritized activities and focuses on repetitive practice of meaningful daily tasks to improve arm and hand function after stroke.
Intervention 2: In-person CPASS therapy In-person CPASS is a clinic-based rehabilitation intervention consisting of 20 hours of therapist-guided, task-specific upper extremity motor training delivered face-to-face. Therapy is individualized based on participant-selected functional goals and focuses on repetitive practice of meaningful daily activities to improve arm and hand function after stroke. Sessions are conducted in a clinical setting under direct supervision of a therapist.

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
Upper Extremity Motor Function (Action Research Arm Test [ARAT])
時間枠:Baseline, 3 months, 6 months, and 12 months
The Action Research Arm Test (ARAT) is a standardized, performance-based measure of upper extremity motor function. It assesses grasp, grip, pinch, and gross movement using a series of functional tasks. Scores range from 0 to 57, with higher scores indicating better motor function.
Baseline, 3 months, 6 months, and 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Upper Extremity Use (Accelerometry)
時間枠:Baseline, 3 months, 6 months, and 12 months
Upper extremity activity is measured using wrist-worn accelerometers on both arms. Data are processed using validated ML algorithms to quantify the amount of functional use of the affected upper extremity during daily activities in home and community environments.
Baseline, 3 months, 6 months, and 12 months
Social Participation (Stroke Impact Scale)
時間枠:Baseline, 3 months, 6 months, and 12 months
The Stroke Impact Scale (SIS) is a patient-reported outcome measure assessing perceived participation in social and community activities. Scores range from 0 to 100, with higher scores indicating better participation.
Baseline, 3 months, 6 months, and 12 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。

捜査官

  • 主任研究者:Dr. Shashwati Geed, PT, PhD、Department of Physical Therapy and Movement Sciences, University of Texas at El Paso

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。

便利なリンク

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)

2025年9月1日

一次修了 (推定)

2028年8月31日

研究の完了 (推定)

2029年8月31日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月16日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月22日

QC基準を満たした最後の更新が送信されました

2026年6月16日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

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

IPD プランの説明

Individual participant data will not be shared because this is a small, single-site rehabilitation trial involving individuals recovering from stroke, and the dataset includes potentially identifiable clinical, functional, accelerometry, and video-derived movement data. The protocol includes video recordings of upper extremity activity scripts and therapy sessions, which are used for frame-by-frame annotation and machine-learning classification of functional arm use. Although study data are coded with randomly generated participant IDs and identifiers are stored separately, the combination of clinical characteristics, timing post-stroke, functional outcomes, accelerometry, and video-derived data may increase the risk of deductive identification. Deidentified aggregate results may be shared through publications and presentations.

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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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