跳至主要内容
临床试验/NCT07685327
NCT07685327招募中不适用

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

Ibadat International University, Islamabad1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Comprehensive Coordination Scale (CCS)

研究概览

简要总结

This randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality (MR) 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 to 19 years will be randomly assigned to one of two treatment groups. The intervention will be provided three times per week for eight weeks. Balance and coordination will be assessed before treatment, at four weeks, and after completion of the intervention using validated clinical outcome measures. The findings of this study may help determine whether immersive Mixed Reality can enhance rehabilitation outcomes in adolescents with cerebral palsy.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This is a single-blinded randomized controlled trial. The participant will be blinded to group allocation throughout the study.

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Willing to participate in the study and provide written informed consent/assent with parental or legal guardian consent where applicable.

排除标准

  • 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.

结局指标

主要结局

Comprehensive Coordination Scale (CCS)

时间窗: Baseline, Week 4, and Week 8

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.

Pediatric Balance Scale (PBS)

时间窗: Baseline, Week 4, and Week 8

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.

次要结局

未报告次要终点

研究者

发起方
Ibadat International University, Islamabad
申办方类型
Other
责任方
Sponsor

研究点 (1)

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