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临床试验/NCT02351596
NCT02351596Unknown不适用

The Effect of a 'Core Stability' Physiotherapy Group Intervention Programme on Balance in Ambulant Children With Cerebral Palsy: A Randomised Control Trial

Royal College of Surgeons, Ireland2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
2
主要终点
Changes in performance of a static balance task ( single leg stand) using three dimensional motion analysis

研究概览

简要总结

This study aims to determine if participation in a core stability physiotherapy group programme can improve the balance of children with cerebral palsy. It is hypothesised that teaching the children how and when to activate their deep core stabilising muscles may help improve their body awareness and their ability to control their alignment and therefore positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who can walk independently, will be randomly selected to join either the control group or intervention group, after completion of their baseline balance assessments. Each group will be re-assessed after completion of their 4 week intervention or control period.

详细描述

Introduction

The 'Core Muscles' are defined as '29 pairs of muscles that support the lumbo-pelvic hip complex in order to stabilize the spine, pelvis and kinetic chain during functional movement'.

Core stability refers to the control, co-ordination and synergism required by the core muscles for the maintenance of functional stability and balance. The role the core musculature plays in movement and postural control is long established. The understanding that our core muscles work in a feed-forward manner, laying the foundation of distal limb movement, formed the basis for studies into the use of core stability training programmes, such as pilates, core control training and spinal stability training, for improved postural control and balance.

Literature is replete with studies investigating the use of core stability programmes for varied populations from the adult population for chronic back pain to elite athletes for injury prevention and performance.

Studies investigating its use in adults with postural control impairment due to upper motor neuron lesions (UMN) from Multiple Sclerosis and Stroke showed positive effects on balance and mobility. The randomised controlled trial, by Chung et al, looked at the effects of a 4 week core stability exercise class on Dynamic Balance and Gait Function of 16 stroke patients. It showed a significant improvement of Timed-Up-And-Go (TUG) scores from 33.06 +-18.39sec to 27.64+- 13.73 sec (p=0.057) in the intervention group. Gait velocity (from 44.83+- 18.83 cm/s to 58.91 +- 18.21 ; p=0.024) and cadence ( from 74.55+- 13.85 steps/min to 84.07 +- 14.00 steps/min ; p=0.041) also showed significant improvement in the intervention group. To date there are no studies investigating the use or potential benefit of specific core stability intervention in the Cerebral Palsy (CP) population.

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
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with spastic Cerebral Palsy (CP)
  • Ages 7 - 17 (inclusive)
  • GMFCS I-II (Gross Motor Function Classification System)
  • Diplegia, Hemiplegia
  • Balance problems identified (Determined by primary PT's treating problem list and/or score on balance assessments in use)
  • Parental Informed Consent
  • Can follow verbal instructions and willing to participate in a group intervention setting

排除标准

  • Recent surgery to lower limbs (within past year)
  • Botulinum Toxin (BTX-A) or serial casting to lower limbs within the last 3 months (or planned for during intervention or control period)
  • Completed a core stability training group within the previous year
  • Neurological or orthopaedic conditions unrelated to CP
  • Behavioural difficulties limiting ability to participate in groups
  • Intellectual difficulty that would make it difficult to comprehend and cooperate with treatment and/or testing

结局指标

主要结局

Changes in performance of a static balance task ( single leg stand) using three dimensional motion analysis

时间窗: Baseline and up to 3 weeks post intervention/control 4 week period

o Relationship of Centre of Mass to Centre of Pressure

Changes in performance of an anticipatory balance task using three dimensional motion analysis

时间窗: Baseline and up to 3 weeks post intervention/control 4 week period

o Kinematic variables relating to trunk, pelvis, hip, knee and ankle movement at key points in the task of tandem walking.

Changes in stride length when balance is challenged during gait using three dimensional gait analysis

时间窗: Baseline and up to 3 weeks post intervention/control 4 week period

o Temporal-spatial parameters of stride length while walking over a 'wobbly road'. ( In gait lab setting this is achieved using bean bags placed under a mat.

次要结局

  • Qualitative data from a post intervention questionnaire to determine the broader effects of the 'Core stability' group intervention on the child's real life function, participation and quality of life.(Up to 1 year Post intervention period)
  • Changes in a series of functional Balance tests: Berg Balance Scale and Functional Walk Test(Baseline and up to 3 weeks post intervention/control 4 week period)

研究者

发起方
Royal College of Surgeons, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dara Meldrum

Dr. Dara Meldrum BSc, MSc, PhD (NUI, RCSI), MISCP

Royal College of Surgeons, Ireland

研究点 (2)

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