Comparing Mixed Reality and Physical Therapy to Improve Balance and Coordination in Adolescents With Spastic Diplegic Cerebral Palsy
Effect Of Fully Immersive Mixed Reality Versus Standard Physical Therapy For Improving Balance And Coordination In Adolescent With Spastic Diplegic Cerebral Palsy" A Randomized Controlled Trial
調査の概要
状態
条件
詳細な説明
erebral palsy (CP) is one of the most common neurological disorders affecting movement, balance, posture, and coordination in children and adolescents. Spastic diplegic cerebral palsy is characterized by increased muscle tone predominantly affecting the lower limbs, resulting in impaired balance, reduced coordination, and limitations in functional mobility. Conventional physical therapy is considered the standard rehabilitation approach; however, patient motivation and treatment adherence may limit its effectiveness.
Mixed Reality (MR) technology provides an immersive and interactive rehabilitation environment that combines virtual and real-world elements, enabling repetitive, task-oriented training with real-time feedback. Such interventions may enhance motor learning, neuroplasticity, patient engagement, and functional recovery. Despite promising evidence regarding immersive virtual reality interventions, limited randomized controlled trials have compared fully immersive Mixed Reality with conventional physical therapy in adolescents with spastic diplegic cerebral palsy.
This single-blinded randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10-19 years who meet the eligibility criteria will be recruited and randomly allocated into two equal groups. Group A will receive fully immersive Mixed Reality training using the Meta Quest Pro platform in combination with standardized physical therapy, while Group B will receive standardized physical therapy alone. Both groups will receive treatment three sessions per week for eight weeks.
Outcome assessments will be performed at baseline, after four weeks, and after completion of the eight-week intervention. Balance will be evaluated using the Pediatric Balance Scale (PBS), while coordination will be assessed using the Comprehensive Coordination Scale (CCS). The findings of this study will provide evidence regarding the effectiveness of fully immersive Mixed Reality as an adjunct to conventional physical therapy and may contribute to improving rehabilitation strategies for adolescents with spastic diplegic 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:Muhammad Ashar Rafi, PhD*
- 電話番号:923083407837
- メール:Ashar.rafi@uipt.iiui.edu.pk
研究連絡先のバックアップ
- 名前:Muhammad Yaseen Khattak, MS-PPT
- 電話番号:923115563552
- メール:yaseenkhattak391@gmail.com
研究場所
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Kpk
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Mansehra、Kpk、パキスタン、21300
- 募集
- Helping hand Comprehansive Physical Rehabilitation Center Mansehra
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コンタクト:
- Muhammad Yaseen Khattak, MS-PPT
- 電話番号:03440957080
- メール:yaseenkhattak391@gmail.com
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Male and female participants.
- Adolescents aged 10 to 19 years.
- Clinically diagnosed with spastic diplegic cerebral palsy.
- Gross Motor Function Classification System (GMFCS) Levels I, II, or III.
- Pediatric Balance Scale (PBS) score greater than 35.
- Willing to participate in the study and provide written informed consent/assent with parental or legal guardian consent where applicable.
Exclusion Criteria:
- Cognitive impairment (MMSE score <24).
- History of seizure disorders.
- Visual or hearing impairment that interferes with participation.
- Diagnosed psychological or psychiatric disorders.
- Any other medical condition that would prevent safe participation in the study.
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:独身
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:Fully Immersive Mixed Reality + Standard Physical Therapy
Participants assigned to the experimental arm will receive fully immersive Mixed Reality (MR) using the Meta Quest Pro platform in combination with standardized physical therapy.
The MR intervention will include interactive applications designed to improve balance and coordination.
Standard physiotherapy will include balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, and strengthening exercises.
Treatment will be provided three sessions per week for eight weeks.
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Participants will receive fully immersive Mixed Reality rehabilitation using the Meta Quest Pro headset in combination with standardized physical therapy.
The intervention includes interactive applications such as Beat Saber, Ball Balance, Run and Cycling, Running Monkeys, and Back to Subway Surfer.
Treatment will be provided three sessions per week for eight weeks to improve balance and coordination in adolescents with spastic diplegic cerebral palsy.
Participants will receive standardized physical therapy consisting of balance training, tandem gait exercises, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program.
Treatment will be provided three sessions per week for eight weeks.
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アクティブコンパレータ:Standard Physical Therapy
Participants assigned to the control arm will receive standardized physical therapy alone, including balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program.
Treatment will be provided three sessions per week for eight weeks.
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Participants will receive standardized physical therapy consisting of balance training, tandem gait exercises, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program.
Treatment will be provided three sessions per week for eight weeks.
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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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Comprehensive Coordination Scale (CCS)
時間枠:Baseline, Week 4, and Week 8
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The Comprehensive Coordination Scale (CCS) will be used to assess motor coordination in adolescents with spastic diplegic cerebral palsy.
Scores will be compared between the intervention and control groups to determine the effect of the interventions on coordination.
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Baseline, Week 4, and Week 8
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Pediatric Balance Scale (PBS)
時間枠:Baseline, Week 4, and Week 8
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The Pediatric Balance Scale (PBS) will be used to evaluate functional balance in adolescents with spastic diplegic cerebral palsy.
Scores will be compared between the intervention and control groups to determine the effect of the interventions on balance.
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Baseline, Week 4, and Week 8
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協力者と研究者
捜査官
- 主任研究者:Muhammad Yaseen Khattak, MS-PPT、Ibadat International University, Islamabad
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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
- IIUI/RERC/ADT/2026/01/214
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
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。