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临床试验/NCT07518511
NCT07518511已完成不适用

Sensory-Enhanced Asynchronous Tele-Rehabilitation Model for Improving Function in Children With Cerebral Palsy: A Randomized Controlled Trial

Cairo University1 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Nine-Hole Peg Test

研究概览

简要总结

PURPOSE: This study evaluated the effectiveness of a Sensory-Enhanced Home-based Intensive Program (SE-HIP), delivered via asynchronous video guidance, compared to a Standard Home Program (SHP) on improving upper limb function in children with cerebral palsy (CP).

BACKGROUND: Children with cerebral palsy (CP) often have upper limb (UL) impairments that limit daily life and participation. Intensive, repetitive therapy is crucial, but traditional delivery has limitations. Home-based programs supported by tele-rehabilitation offer increased dosage and accessibility. Asynchronous models delivered via video guidance are flexible but are less studied for intensive upper limb therapy. Sensory processing deficits are common in cerebral palsy; integrating sensory enhancement may augment motor learning. Evidence combining sensory-enhanced intensive upper limb programs delivered asynchronously is lacking.

HYPOTHESES: The investigators hypothesized that children receiving the Sensory-Enhanced Home-based Intensive Program (SE-HIP) would demonstrate significantly greater improvements in primary upper limb functional outcomes, measured by the Box and Block Test (BBT) and the Nine-Hole Peg Test (NHPT), compared to those receiving the Standard Home Program (SHP).

RESEARCH QUESTION: Does a sensory-enhanced, asynchronous video-guided home program lead to significantly greater improvements in upper limb function (manual dexterity measured by the Box and Block Test (BBT) and the Nine-Hole Peg Test (NHPT)) compared to a standard video-guided home program in children with cerebral palsy (CP)?

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)

入排标准

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

入选标准

  • Mild spasticity (MAS 1 or 1+), independent ambulation (AFOs permitted), and the ability to follow simple instructions

排除标准

  • Significant fixed deformities, cognitive or sensory impairments hindering participation, uncontrolled epilepsy, or recent interventions like botulinum toxin or orthopedic surgery

研究组 & 干预措施

Sensory-Enhanced Home-based Intensive Program (SE-HIP)

Experimental

Children receive videos that include sensory preparation and intensive motor practice as part of the Sensory-Enhanced Home-based Intensive Program (SE-HIP).

干预措施: Sensory-Enhanced Home-based Intensive Program (SE-HIP) (Other)

Standard Home Program (SHP)

Active Comparator

Children receive videos that cover standard activities as part of the Standard Home Program (SHP).

干预措施: Standard Home Program (SHP) (Other)

结局指标

主要结局

Nine-Hole Peg Test

时间窗: Baseline and after 6 weeks of training

Assesses fine manual dexterity (finger dexterity). The patient places and removes nine pegs into a board as quickly as possible.

Box and Block Test

时间窗: Baseline and after 6 weeks of training

Assesses gross manual dexterity. The patient moves small wooden blocks across a partition in 60 seconds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamer Mohamed El-Saeed

Associate Professor

Cairo University

研究点 (1)

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