Sensory-Motor Integration Versus Virtual Reality-Based Exercise in Children With Cerebral Palsy
Comparative Clinical Effectiveness of Sensory-Motor Integration and Virtual Reality-Based Exercise Programs for Enhancing Functional Mobility in Children With Cerebral Palsy: Strengthening Steps Through Play and Technology
This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Both groups will continue to receive standard conventional physiotherapy. In addition, one group will receive a structured sensory-motor integration-based exercise program, while the other group will receive a Nintendo Wii Sports-based virtual reality exercise program. The intervention period will last 16 weeks, with two sessions per week. Outcomes will be assessed before and after the intervention using standardized clinical measures.
調査の概要
状態
条件
詳細な説明
Cerebral palsy is a non-progressive neurodevelopmental condition characterized by permanent impairments in movement, posture, and motor function. Children with cerebral palsy may experience limitations in postural control, balance, motor planning, sensory processing, functional mobility, and participation in physical activity. Conventional physiotherapy is widely used in the rehabilitation of children with cerebral palsy and commonly includes tone regulation, stretching, strengthening, balance training, aerobic exercises, and functional activity training. However, additional rehabilitation approaches may be needed to support multidimensional motor and functional outcomes.
This study is designed as a two-arm, randomized controlled, parallel-group, prospective clinical intervention study. The aim is to compare the effects of two adjunctive rehabilitation approaches added to standard conventional physiotherapy: a Sensory-Motor Integration-Based Exercise Program and a Virtual Reality-Based Exercise Program using Nintendo Wii Sports.
Eligible children with cerebral palsy will be enrolled after obtaining informed consent from their legal guardians. Participants will be randomly assigned to one of two groups using a computer-based simple randomization method.
Participants in the first group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. This program is designed to target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs.
Participants in the second group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. This program will provide visual and auditory feedback in a game-based environment and will aim to increase motivation, task-oriented movement repetition, balance, and functional motor performance.
The intervention period will last 16 weeks, with two sessions per week for both groups. All participants will be evaluated at baseline before the intervention and after completion of the 16-week intervention period. The primary outcome measures will include the Gross Motor Function Measure dimensions D and E, the Pediatric Balance Scale, and the Timed Up and Go Test. Secondary outcome measures will include ABILHAND-Kids, hand grip strength measured with a dynamometer, and the Physical Activity Self-Efficacy Scale for Children.
The study is expected to provide clinical evidence regarding the comparative effectiveness of sensory-motor integration-based exercises and virtual reality-based exercises as adjunctive interventions to conventional physiotherapy in children with cerebral palsy.
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：Elif Develi, PhD
- 電話番号：+90 555 593 6293
- メール：elifstn@yahoo.com
研究場所
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Istanbul、トルコ（Türkiye）
- Metin Sabancı İlköğretim Okulu
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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:
- Diagnosed with cerebral palsy, including diplegic, hemiplegic, or dyskinetic types
- Gross Motor Function Classification System level I, II, or III
- Aged between 6 and 12 years
- Having sufficient cognitive ability to understand and follow simple verbal instructions
- Voluntary participation in the study with legal guardian consent
Exclusion Criteria:
- Gross Motor Function Classification System level IV or V
- Spasticity level of 2 or higher in target muscle groups according to the Modified Ashworth Scale
- Botulinum toxin injection within the last 6 months
- Orthopedic or neurological surgery affecting motor function within the last 6 months
- History of uncontrolled epilepsy or neurological conditions contraindicating virtual reality applications
- Severe visual or hearing impairment that may prevent participation in the study
- Concurrent participation in another rehabilitation program during the study period
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：Sensory-Motor Integration-Based Exercise Program
Participants in this group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. The program will target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The intervention will be delivered for 16 weeks, two sessions per week. |
A structured sensory-motor integration-based exercise program targeting postural control, balance, motor planning, sensory processing, body awareness, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The program will be administered in addition to standard conventional physiotherapy.
他の名前：
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アクティブコンパレータ：Virtual Reality-Based Exercise Program
Participants in this group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. The program will provide visual and auditory feedback in a game-based environment and will aim to improve motivation, task-oriented movement repetition, balance, and functional motor performance. The intervention will be delivered for 16 weeks, two sessions per week. |
A Nintendo Wii Sports-based virtual reality exercise program using visual and auditory feedback in a game-based environment to support motivation, task-oriented movement repetition, balance, and functional motor performance. The program will be administered in addition to standard conventional physiotherapy.
他の名前：
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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 Gross Motor Function Measure Dimensions D and E Score
時間枠：Baseline and week 17
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Gross motor function will be assessed using the Gross Motor Function Measure, dimensions D and E. The assessment will evaluate standing, walking, running, and jumping-related gross motor abilities in children with cerebral palsy. |
Baseline and week 17
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Change in Pediatric Balance Scale Score
時間枠：Baseline and week 17
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Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance. |
Baseline and week 17
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Change in Timed Up and Go Test Performance
時間枠：Baseline and week 17
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Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Shorter completion time indicates better functional mobility. |
Baseline and week 17
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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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Change in ABILHAND-Kids Score
時間枠：Baseline and week 17
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Upper extremity and hand function in daily activities will be assessed using the ABILHAND-Kids questionnaire completed with parent or caregiver report. |
Baseline and week 17
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Change in Hand Grip Strength
時間枠：Baseline and week 17
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Hand grip strength will be measured using a calibrated hand dynamometer according to a standardized testing position. Measurements will be performed for each hand, and the highest value will be used for analysis. |
Baseline and week 17
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Change in Physical Activity Self-Efficacy Scale for Children Score
時間枠：Baseline and week 17
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Physical activity self-efficacy will be assessed using the Physical Activity Self-Efficacy Scale for Children to evaluate children's perceived confidence and ability to participate in physical activity. |
Baseline and week 17
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協力者と研究者
スポンサー
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
- YEDU-FTR-CP-SMI-VR-2026-001
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
Individual participant data will not be shared due to the small sample size, pediatric population, and privacy considerations. De-identified aggregate results may be reported in scientific publications or presentations.
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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