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临床试验/ACTRN12616000744459
ACTRN12616000744459招募中未知

Feasibility of functional electrical stimulation cycling exercise in persons with moderate cerebral palsy: a pilot study

Dr Che Fornusek0 个研究点目标入组 12 人开始时间: 2016年6月6日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
12

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
13 Years 至 18 Years(—)
性别
All

入选标准

  • The inclusion criteria for participants are:
  • 1) 13-18 years old
  • 2) The diagnosis of Cerebral Palsy
  • 3) GMFCS Level III (uses an assistive mobility device or a wheelchair for long distances)
  • 4) Sufficient covering of the femoral head in the acetabulum (MIGR% < 40%) and no significant scoliosis (primary curve >40 degrees).
  • 5) Absence of severe tactile hypersensitivity in the lower extremities
  • 6) Visuoperceptual skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
  • 7) The ability to maintain an upright position with minimal support and to sit in a wheelchair for approximately one hour.
  • 8) Have adequate passive range of motion of the hips, knees and ankle to complete a full revolution of the cycle ergometer.
  • 9) Ability to communicate pain or discomfort directly with the researcher or indirectly via a carer to participate in cycling trials (Communication Function Classification System less than or equal to 3)
  • 10) The willingness to participate in two training sessions per week for 8 weeks lasting approximately 1 hour each session (approximately 15 min of set up and up to 45 minutes of training) and to complete 2-3 days of testing during each assessment period (baseline, post testing).
  • 11) The ability to gain consent from participant and parent/guardian

排除标准

  • Exclusion criteria are:
  • 1) Lower extremity joint pain during cycling
  • 2) Spinal fusion that extends to the pelvis
  • 3) Hip, knee, or ankle joint instability or dislocation
  • 4) History of lower limb stress fractures in the past year
  • 5) Pulmonary disease limiting exercise tolerance
  • 6) Symptomatic or known cardiac disease
  • 7) Unhealed wounds or pressure sores
  • 8) Muscles that are non-responsive to electrical stimulation
  • 9) History of surgery or traumatic fracture to the lower extremities within the past year
  • 10) Botox injections to the lower extremity muscles within the past 6 months.
  • 11) Severe spasticity in legs (score of 4 on the Modified Ashworth scale)
  • 12) Severely limited range of joint motion/irreversible muscle contractures that prevent the subject from being able to be safely positioned on the cycle.
  • 13) Presence of an uncontrolled seizure disorder
  • 14) Pregnancy

研究者

发起方
Dr Che Fornusek

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