Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy (UL/SMC/ADL/CP)
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy: A Randomized Controlled Trial
The purposes of the current study will be to assess the effect of robotic gloves training on upper limb coordination, selective motor control (Wrist Extension/Flexion, Finger Flexion/Extension, Thumb Opposition (tip to tip pincer), Thumb extension (key grip) and activities of daily living in children with hemiparetic cerebral palsy.
調査の概要
詳細な説明
Cerebral palsy (CP) is a group of conditions that affect movement and posture. It's caused by damage that occurs to the developing brain, most often before birth.
Etiological aspects of CP can be defined as prenatal etiology in 22% of the cases, probable perinatal etiology in 40% and undefined etiology in 38% of the cases.
Children with CP commonly have impairment of upper limb function, with various studies reporting a prevalence ranging from 57 to 83%.
Cerebral palsy (CP) also limits the International Classification of Functioning, Disability and Health (ICF) domain of activities, which refers to the ability to execute an essential task or action of daily living (e.g., eating, drinking, grooming, or dressing).
Hemiparetic CP is a form of CP in which one arm and leg on either the right or left side of the body is affected. Hemiparetic CP is the most common CP syndrome in children born at term.
Children with hemiparetic CP have unilateral prehensile dysfunction as a consequence of lesions in the sensorimotor cortex and corticospinal tract. Children whose hemiparesis involves the upper limb to a greater extent than the lower (arm-dominant hemiparesis) are much more likely to experience learning difficulties than those whose clinical pattern is leg-dominant.
Upper limb coordination is crucial for hand functional manual abilities and plays a vital role in functional independence and overall quality of life. Therefore, targeting upper limb coordination approaches with older children with CP is essential for maintaining or improving their performance.
Selective motor control is defined as isolated muscle activation during a voluntary posture or movement in a selected motion pattern. Therefore, SMC should be considered during evaluation and rehabilitation of affected UEF in children with spastic CP. However, there are not enough studies in the literature.
Children with unilateral spastic CP seldom use their paretic hand spontaneously in daily activities.
Children with hemiplegia often display difficulties in mobility and sensory functioning. These difficulties affect their activities in daily living and thus have a negative impact on the quality of their life.
Robotic gloves are more compact forms than exoskeleton devices. The structure of robotic devices is similar to a glove and envelops the paretic hand. The glove-like nature of these devices gives them intuitive functionality and can reduce stresses on the hand joints.
A direct benefit of assistive robotic gloves has been demonstrated over recent years on strength and functional ability in multiple studies with spinal cord injury (SCI) patients, stroke patients, and children with neurological hand limitations and elderly with age-related hand limitations.
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：Rabab Ragab, phd
- 電話番号：02 01227110268
- メール：drrababragab14@gmail.com
研究場所
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Cairo、エジプト
- Outpatient Clinic of Faculty of Physical Therapy, Cairo University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
- Diagnosis of unilateral spastic cerebral palsy (hemiparetic CP).
- Age ranging from [e.g., 6 to 8] years old.
- Level I, II on the Gross Motor Function Classification System (GMFCS).
- Level II, III on the Manual Ability Classification System (MACS).
- Sufficient cognitive ability and cooperation to understand instructions and follow verbal commands during training sessions.
- Mild to moderate spasticity in the affected upper limb, scoring [e.g., ≤ 2] on the Modified Ashworth Scale (MAS).
- Passive range of motion of the affected wrist and fingers adequate to fit comfortably inside and be assisted by the robotic glove device.
- Legal guardians/parents willing and able to provide written informed consent, and child assent obtained where applicable.
Exclusion Criteria
- Severe upper limb fixed contractures or structural joint deformities that prevent proper fitting or passive movement of the robotic glove.
- Severe spasticity or rigid hypertonia scoring [e.g., > 2] on the Modified Ashworth Scale (MAS) in the target upper extremity.
- Recent orthopedic surgery or botulinum toxin (Botox) injections in the affected upper limb within the past [e.g., 3 to 6] months.
- Co-existing severe visual, hearing, or sensory impairments that significantly impede the ability to interact with the device or interactive gaming interfaces.
- Uncontrolled epilepsy or history of severe, frequent seizures triggered by visual stimuli or active exertion.
- Severe cognitive, behavioral, or psychological disorders that prevent compliance with the therapeutic protocol.
- Simultaneous participation in another active upper limb rehabilitation clinical trial or intensive therapeutic protocol.
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 |
|---|---|
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実験的：Robotic Glove Therapy
"Children with hemiplegic cerebral palsy in this group will perform structured upper limb coordination, selective motor control, and activities of daily living (ADL) training while wearing a robotic glove. The intervention utilizes the device's individual finger control capabilities to facilitate independent finger movement and targeted manual dexterity exercises." |
"A rehabilitation program using a high-tech robotic glove that features individual finger control to allow independent finger movement. Participants will use the device to perform repetitive task-specific training, upper limb coordination drills, and activities of daily living (ADL) exercises designed to improve hemiparetic hand functionality and selective motor control." |
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アクティブコンパレータ：Conventional Occupational Therapy
"Children with hemiplegic cerebral palsy in this group will receive standard, conventional occupational therapy sessions. The intervention focuses on identical upper limb coordination exercises, selective motor control training, and functional activities of daily living (ADL) training using traditional manual techniques without the assistance of a robotic device." |
"A traditional rehabilitation program focused on upper limb mobilization, functional manual dexterity training, and activities of daily living (ADL) tasks. Exercises are performed using standard clinical therapeutic equipment and manual therapist facilitation without any robotic device assistance." |
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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Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) - Upper Limb Coordination Subtest
時間枠：Baseline (Week 0) and post-intervention (Week 12)
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The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Upper Limb Coordination Subtest is a standardized, norm-referenced measure designed to evaluate precise arm and hand movements, visual-tracking, and object manipulation. It consists of 7 items. The raw scores are converted into point scores, which are then translated into a standard subtest score. The minimum score is 1 and the maximum score is 30. Higher scores mean a better outcome, indicating superior upper limb coordination and manual proficiency. |
Baseline (Week 0) and post-intervention (Week 12)
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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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Test of Selective Control (TASC) Score
時間枠：Baseline (Week 0) and post-intervention (Week 12)
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The Test of Selective Control (TASC) is a clinical assessment tool used to quantify selective motor control in the upper limbs of children with cerebral palsy. It evaluates the child's ability to isolate movements at specific joint levels (including the shoulder, elbow, forearm, wrist, and fingers) without involuntary trunk movement or mirror movements on the opposite side. Each joint movement is graded on a scale from 0 to 2. The total score is calculated by summing the joint scores, where the minimum score is 0 and the maximum score is 28. Higher scores mean a better outcome, indicating superior and more isolated selective motor control. |
Baseline (Week 0) and post-intervention (Week 12)
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Functional Independence Measure for Children (WeeFIM) - Self-Care Domain
時間枠：Baseline (Week 0) and post-intervention (Week 12)
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The Functional Independence Measure for Children (WeeFIM) Self-Care domain is a standardized, discipline-free assessment tool used to evaluate functional independence and the burden of care in children with neurodevelopmental disabilities. The Self-Care domain consists of 8 items, including eating, grooming, bathing, upper body dressing, lower body dressing, toileting, bladder management, and bowel management. Each item is scored on a 7-point ordinal scale ranging from 1 (total assistance) to 7 (complete independence). For this specific domain, the minimum score is 8 and the maximum score is 56. Higher scores mean a better outcome, indicating greater functional independence in activities of daily living and less reliance on caregiver assistance. |
Baseline (Week 0) and post-intervention (Week 12)
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協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
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/012/006155
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
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