Effect of Adding Augmented Cues /Hand Stroke Patient (AUGMENTED CUES)
Effect of Adding Augmented Cues to Physical Therapy Intervention on Hand Function Post Stroke Patients
調査の概要
詳細な説明
Stroke is one of the leading causes of long-term disability worldwide and frequently results in impaired hand function, reduced dexterity, decreased grip strength, and limitations in activities of daily living. Conventional physical therapy is commonly used to improve upper extremity function; however, recovery of hand performance remains challenging for many stroke survivors.
Augmented cues provide additional sensory information through visual, auditory, or sensorimotor feedback that may enhance motor learning and neuroplasticity. Incorporating augmented cues into rehabilitation programs may improve patient engagement, increase repetition of task-specific movements, and facilitate functional recovery.
The purpose of this randomized controlled trial is to examine the effectiveness of adding augmented cue-based training to conventional physical therapy intervention in improving hand function among patients with subacute ischemic stroke.
A total of 50 participants meeting the eligibility criteria will be recruited and randomly assigned into two equal groups:
Study Group: Participants will receive augmented cue-based training combined with conventional physical therapy.
Control Group: Participants will receive conventional physical therapy only.
The intervention will be conducted over an eight-week treatment period. Outcome measures will be collected before and after treatment and will include:
- Nine-Hole Peg Test (NHPT) to assess manual dexterity.
- Hand grip strength measured using a hand dynamometer.
- Pressure pain threshold measured using a pressure algometer.
The primary objective is to determine whether the addition of augmented cues results in greater improvement in hand function compared with conventional physical therapy alone. The results may contribute to the development of more effective rehabilitation strategies for individuals recovering from stroke.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mostafa abdullah ahmed, MD
- 電話番号：00201095052373
- メール：dr.mostafa.abdullah.abdelaziem@gmail.com
研究連絡先のバックアップ
- 名前：mariam mohamed elsayed, phd
- 電話番号：002010950505529
- メール：mariamelanany5@gmail.com
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- - Male and female patients.
- Age between 40 and 60 years.
- First-ever subacute ischemic stroke.
- Time since stroke between 6 weeks and 6 months.
- Unilateral upper limb involvement.
- Able to understand and follow verbal instructions.
- Medically stable and able to participate in the rehabilitation program.
- Willing to provide informed consent.
Exclusion Criteria:
- - Hemorrhagic stroke.
- Bilateral stroke involvement.
- Severe cognitive impairment or severe aphasia interfering with participation.
- Severe visual or auditory deficits affecting training.
- Severe upper limb spasticity that prevents hand training.
- Other neurological disorders affecting upper limb function.
- Severe musculoskeletal disorders of the upper limb.
- Participation in another rehabilitation trial during the study period.
- Unstable cardiovascular or medical conditions.
研究計画
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：なし（オープンラベル）
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：control group
Participants will receive a conventional physical therapy program for hand rehabilitation after stroke.
Treatment will be administered three times per week for eight weeks (24 sessions), with each session lasting 60 minutes and including range of motion exercises, strengthening exercises, stretching, and task-oriented hand training.
|
Participants will receive a conventional physical therapy program for upper limb and hand rehabilitation after stroke.
The program includes stretching exercises, range of motion exercises, strengthening exercises, and task-oriented hand training.
Treatment will be provided three times per week for eight weeks (24 sessions).
|
|
実験的：musical gloves
articipants will receive the same conventional physical therapy program provided to the control group in addition to MusicGlove training.
Treatment will be administered three times per week for eight weeks (24 sessions).
MusicGlove will provide augmented visual, auditory, and performance feedback during task-specific hand training.
|
Participants will receive a conventional physical therapy program for upper limb and hand rehabilitation after stroke.
The program includes stretching exercises, range of motion exercises, strengthening exercises, and task-oriented hand training.
Treatment will be provided three times per week for eight weeks (24 sessions).
MusicGlove is a sensor-based rehabilitation device that provides augmented visual, auditory, and performance feedback during task-specific hand exercises.
Participants perform repetitive thumb-to-finger opposition and grasping movements synchronized with computer-based musical activities.
Training will be provided in addition to conventional physical therapy three times per week for eight weeks.
|
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 |
|---|---|---|
|
Nine-Hole peg Test (NHPT)
時間枠：Baseline and after 8 weeks of treatment
|
Manual dexterity assessed using the Nine-Hole Peg Test.
The time required to place and remove nine pegs will be recorded in seconds.
Lower scores indicate better hand dexterity.
|
Baseline and after 8 weeks of treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
hand grip strength
時間枠：Baseline and after 8 weeks of treatment
|
Hand grip strength will be assessed using a calibrated hand dynamometer.
Participants will perform maximal voluntary grip contractions, and the average value of three trials will be recorded in kilograms.
Higher values indicate greater hand strength.
|
Baseline and after 8 weeks of treatment
|
|
pressure pain threshold
時間枠：Baseline and after 8 weeks of treatment
|
Pressure pain threshold of the Extensor Carpi Radialis Brevis muscle will be measured using a digital pressure algometer.
Pressure will be applied at a standardized rate until the participant first perceives pain.
Higher values indicate lower pain sensitivity.
|
Baseline and after 8 weeks of treatment
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Moshera H Darwish, PHD、Professor of Physical Therapy for Neurology and Neurosurgery Faculty of Physical Therapy Cairo University
- スタディディレクター：mariam m elsayed, phd、Lecturer in department of physical Therapy for Neurology and Neurosurgery Faculty of physical therapy Cairo University
- スタディディレクター：Essam M Abdulwahab, PHD、Professor of Neurology Faculty of Medicine Al-Azhar university
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- P.T.REC/012/006310
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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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