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临床试验/NCT07125807
NCT07125807已完成不适用

Upper Extremity Plyometric Versus Resistance Exercises to Enhance Trunk Balance in Children With Spina Bifida: A Randomized Controlled Trial

Okan University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
Trunk Control Measurement Scale (TCMS)

研究概览

简要总结

Objective: To compare the efficacy of upper extremity plyometric and resistance exercises in improving trunk balance in children with Spina Bifida (SB).

Methods: This randomized controlled trial (RCT) enrolled 28 children (aged 6-12 years) with lumbar-level SB, randomized to plyometric (n=14) or resistance (n=14) exercise groups for an 8-week intervention (3 days/week) alongside standard rehabilitation. Primary outcomes included Trunk Control Measurement Scale (TCMS) for static/dynamic sitting and reaching, and Pediatric Balance Scale (PBS) for overall balance. Secondary outcomes included ambulation levels via Hoffer classification.

详细描述

Objective

To compare the effectiveness of upper extremity plyometric versus resistance exercises in enhancing trunk balance among children with lumbar-level Spina Bifida (SB).

Methods:

This randomized controlled trial included 28 children (aged 6-12 years) diagnosed with lumbar-level SB. Participants were randomly assigned to either a plyometric exercise group (n = 14) or a resistance exercise group (n = 14). Both groups received an 8-week intervention (three sessions per week) in addition to their standard rehabilitation programs.

Primary outcomes were assessed using the Trunk Control Measurement Scale (TCMS)-evaluating static sitting, dynamic sitting, and reaching control-and the Pediatric Balance Scale (PBS) to assess overall balance capabilities. Secondary outcomes included ambulation status, measured using the Hoffer classification.

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 (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The study included children diagnosed with lumbar-level Spina Bifida,
  • Aged 6 to 15 years,
  • IQ of 50 or higher based on the SPARCLE cognitive assessment

排除标准

  • History of shunt infection or revision,
  • Tethered cord syndrome or syringomyelia,
  • Insufficient sitting balance,
  • Upper extremity spasticity or contractures,
  • Severe visual or hearing impairments

结局指标

主要结局

Trunk Control Measurement Scale (TCMS)

时间窗: Day 1, right before starting treatment and right after finishing the treatment (4 weeks). using questionary scores

It measures both static and dynamic trunk control, including selective motor control and dynamic reaching abilities. The total TCMS score ranges from 0 to 58 points. Higher scores on the TCMS indicate better trunk control and function.

Pediatric Balance Scale (PBS)

时间窗: Day 1, right before starting treatment and right after finishing the treatment (4 weeks). using questionarry scores

It is a reliable and valid clinical tool designed to assess functional balance in children aged 5 to 15 years with mild to moderate balance impairments. It is a modified version of the Berg Balance Scale tailored specifically for pediatric use, focusing on balance performance during daily functional tasks. The PBS consists of 14 items, each scored on a 5-point scale from 0 to 4: The total PBS score ranges from 0 to 56 points (14 items x 4 points each). Higher scores indicate better functional balance and motor performance.

次要结局

未报告次要终点

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozgur Surenkok

Assit.Professor

Okan University

研究点 (1)

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