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The Effect of Home-Based Telerehabilitation in Individuals With Stroke

2021年10月8日 更新者:Recep Ormen、Istanbul University - Cerrahpasa (IUC)

The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke

Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers.

In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.

調査の概要

研究の種類

介入

入学 (予想される)

40

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:Recep Ormen, M.Sc
  • 電話番号:+905316777334
  • メールrormen@gmail.com

研究場所

    • Bakirkoy
      • Istanbul、Bakirkoy、七面鳥、34100
        • 募集
        • Istanbul University-Cerrahpaşa
        • 副調査官:
          • Yonca Zenginler Yazgan, PhD
        • 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

25年~65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:

  • Diagnosed with stroke at least 1 year ago by a neurologist
  • Modified Rankin score ≤3
  • Have an internet infrastructure that can be accessed at home
  • Not participated in a standardized physiotherapy program in the past 3 months

Exclusion Criteria:

  • Presence of blurred or low vision problems
  • Hearing and speech impairment at a level that will affect participation in the system
  • Epilepsy
  • Presence of pregnancy
  • Having any cognitive problems that prevent using the system

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:Telerehabilitation Group
This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks.
Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.
実験的:Control Group
This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.
Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.

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
Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.
Baseline and end of weeks 8
Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.
Baseline and end of weeks 8
Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
Baseline and end of weeks 8
Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
Baseline and end of weeks 8
Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.
Baseline and end of weeks 8

二次結果の測定

結果測定
メジャーの説明
時間枠
Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
It is a 14-item scale that measures the patient's confidence in falling.
Baseline and end of weeks 8
WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
It is a health-related quality of life scale developed by the World Health Organization. A national question was added to the Turkish version of the scale in addition to the original version.
Baseline and end of weeks 8
Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
時間枠:Baseline and end of weeks 8
It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own.
Baseline and end of weeks 8
Global Rating of Change Scales
時間枠:End of weeks 8
It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
End of weeks 8
System Usability Scale
時間枠:End of weeks 8
It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.
End of weeks 8

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

  • スタディチェア:Yonca Zenginler Yazgan, PhD、Istanbul University-Cerrahpasa Faculty of Health Science
  • 主任研究者:Recep Ormen, M.Sc、Istanbul University-Cerrahpasa Institute of Postgraduate Education

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10月4日

一次修了 (予想される)

2022年8月4日

研究の完了 (予想される)

2022年12月28日

試験登録日

最初に提出

2021年10月8日

QC基準を満たした最初の提出物

2021年10月8日

最初の投稿 (実際)

2021年10月19日

学習記録の更新

投稿された最後の更新 (実際)

2021年10月19日

QC基準を満たした最後の更新が送信されました

2021年10月8日

最終確認日

2021年10月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

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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