Effects of Remote Limb Ischemic Conditioning to Enhance Muscle Power, Dynamic Balance, and Walking Performance in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Peak knee extension power
研究概览
简要总结
The purpose of this research study is to determine if remote limb ischemic conditioning (RLIC) can increase skeletal muscle power, enhance learning of motor (dynamic balance) task, and improve walking performance in children with cerebral palsy (CP).
详细描述
Ischemic conditioning is a phenomenon in which an organ exposed to a controlled, short-term, local, sublethal ischemia protects from subsequent ischemia. Remote ischemic conditioning is another more practical approach where transient ischemia and reperfusion applied to a remote organ or tissue, protects other organs or tissues from further episodes of lethal ischemia/reperfusion injury. Remote limb ischemic conditioning (RLIC) is a clinically feasible way of performing remote ischemic conditioning where alternating, brief ischemia and reperfusion is delivered with cyclic inflation and deflation of a blood pressure cuff on the arm or leg.
The overall goal of this research is to use ischemic conditioning to enhance muscle power, motor leaning, and mobility in children with CP. Our previous work demonstrated that when paired with strength training, RLIC improved muscle strength and activation in healthy, young adults and motor learning in healthy older adults. The current study extends that work to determine if RLIC enhances muscle power, dynamic balance, and walking performance in children with CP. This Phase II study will yield the necessary information to design and execute subsequent randomized controlled trials in children with CP as well as other neurological conditions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are masked to group assignment (RLIC vs. Sham conditioning) and the assessor will be masked to group assignment of the participants.
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with unilateral or diplegia cerebral palsy (CP)
- •Gross Motor Function Classification System (GMFCS) levels I-III
排除标准
- •Children with other developmental disabilities such as autism, developmental coordination disorders, etc.
- •Children with cognitive deficits or communication problem
- •Children with balance disorders such as vestibular disorders, posterior fossa tumors etc.
- •Children with known cardiorespiratory dysfunctions
- •Children who are receiving other adjunct therapies such as TMS, tDCS, vagal nerve stimulation
- •Presence of lower extremity condition, injury, or surgery which could compromise conditioning and training
- •Children with sickle cell disease
研究组 & 干预措施
Remote Limb Ischemic Conditioning (RLIC)
RLIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the more involved thigh. RLIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RLIC is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: RLIC (Behavioral)
Remote Limb Ischemic Conditioning (RLIC)
RLIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the more involved thigh. RLIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RLIC is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: Muscle Power training (Behavioral)
Remote Limb Ischemic Conditioning (RLIC)
RLIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the more involved thigh. RLIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RLIC is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: Balance training (Behavioral)
Remote Limb Ischemic Conditioning (RLIC)
RLIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the more involved thigh. RLIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RLIC is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: Treadmill Training (Behavioral)
Sham Conditioning
Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved thigh. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: Sham Conditioning (Behavioral)
Sham Conditioning
Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved thigh. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: Muscle Power training (Behavioral)
Sham Conditioning
Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved thigh. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: Balance training (Behavioral)
Sham Conditioning
Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved thigh. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-14.
Interventions:
- Behavioral: RLIC
- Behavioral: Muscle power training
- Behavioral: Balance training
- Behavioral: Treadmill training
干预措施: Treadmill Training (Behavioral)
结局指标
主要结局
Change in Peak knee extension power
时间窗: Pre-intervention to 1 month post-intervention follow-up
Power is defined as the ability to exert a maximum force in short amount of time (speed) while performing knee extension. Bilateral quadriceps power will be measured using Humac Norm Isokinetic testing device (Computer Sports Medicine Inc, Stoughton, MA).
Change in Balance Score
时间窗: Pre-intervention to 1 month post-intervention follow-up
The average amount of time in seconds that a participant maintains the stability platform within ±5° of horizontal position during 15 trials of 30 seconds each. The total score will range between 0-30 seconds. Higher balance score indicates better balance performance.
Change in Walking Speed
时间窗: Pre-intervention to 1 month post-intervention follow-up
Self-selected and fast walking speeds will be measured using 10-meter walk test.
次要结局
- Quadriceps Electromyography(Pre-intervention to 1 month post-intervention follow-up)
- Gait Analysis(Pre-intervention to 1 month post-intervention follow-up)
- Lower limb activity(Pre-intervention to 1 month post-intervention follow-up)
研究者
Swati Manoharrao Surkar
Assistant Professor
East Carolina University