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
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