NCT05261048Unknown不适用
Effects of Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
University of Lahore2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1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
- 60
- 试验地点
- 2
- 主要终点
- Trunk Impairment Scale
研究概览
简要总结
The study will be randomized controlled trial. This study will be conducted in Children Hospital Pakistan. A sample size of 60 will be randomly allocated into two groups, (30 participants in each group), by lottery method.
- The participants randomly allocated into control group A, will receive conventional physiotherapy in the form of truncal exercises, which consists of upper and lower part of the trunk in spine and sitting position for a total 30 minutes including rest periods in between, once in a day for 4 days per week.
- Participants in experimental group B receive both conventional physiotherapy and Pelvic Proprioceptive Neuromuscular Facilitation for 30 minutes, once in a day, 4 days per week for 12 weeks.
- The experimental group received anterior elevation-Posterior depression pattern with the techniques of Rhythmic initiation, Slow reversal and Stabilizing reversal.
- Affected side of the pelvis was given these techniques for total 30 minutes with 15 minutes of pelvic PNF in one session with rest periods in between.
- Baseline data will be collected at baseline, 6 weeks and 12 weeks during follow up through Trunk Impairment scale (TIS) and Pediatric balance scale (PBS).
详细描述
- Recruitment: Participants who met the inclusion/exclusion will be recruited from the outpatient Department of Pediatric Rehabilitation of the children hospital.
- Screening: Participants will be considered eligible for entering the study with Gross motor function level 1 and 2 ( walk with or without limitation) and spasticity range between grade 1 and 2 according Modified Ashworth scale.
- Gross Motor Function Classification System (GMFCS): Children who can walk independently without assistance are categorized into GMFCS levels I and II, whereas those who cannot walk independently and need assistance or gait assistive device for ambulation are categorized into levels III and V.
- Modified Ashworth scale: It will be assessed while moving from extension to flexion scoring 0 No increase in tone. 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM). 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed. 3 considerable increase in tone, passive movement difficult. 4 limb rigid in flexion or extension
- Randomization and allocation: Afterwards, participants will be conforming the eligibility criteria will be randomly allocated, through lottery method, into two experimental groups (Group A, Group B).
- Blindness: The study will be single blinded. The assessor will be unaware of the treatment given to both groups.
- Intervention: The participants randomly allocated to control group A, will receive conventional physical therapy in the form of truncal exercises, which consists of upper and lower part of the trunk in spine and sitting position for 30 minutes including rest intervals in between.
- Participants in experimental group B, will receive pelvic proprioceptive neuromuscular facilitation in addition to conventional physical therapy for 30 minutes each, once in a day, 4 days per week for 12 weeks.
- Duration: Forty eight sessions will be given over a period of 12 weeks for each session of 30 minutes.
- Outcome Variables and measures:
- Trunk Control(Trunk Impairment scale (TIS)
- Balance (Pediatric balance scale (PBS)
- Outcome measures will be taken at baseline, 6 weeks and 12 weeks during follow up.
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)
盲法说明
Single (Outcome Assessor) Study will be single blinded. The assessor will be unaware of the treatment given to both groups.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed as Spastic hemiplegic cerebral palsy
- •Age group (5-12) years
- •Both male and female
- •Gross motor function level 1 and 2 ( walk with or without limitation)
- •Spasticity range between grade 1 and 2 according Modified Ashworth scale
- •Able to follow the simple verbal instructions.
排除标准
- •Children with visual, auditory, vestibular or perceptual deficit.
- •Any Fracture
- •Other neurological and cardio logical conditions( mental disorder, epilepsy, autism)
- •Cognitive impairments
- •Other types of CP
结局指标
主要结局
Trunk Impairment Scale
时间窗: 12 weeks
It is used to assess trunk control including static and dynamic-sitting balance, and upper and lower trunk coordination during trunk rotation while sitting. Each item was graded on a 2-4-point ordinal scale. The highest possible scores for the static- and dynamic-sitting balance tests, and the trunk coordination test were 7, 10, and 6, and the total TIS score ranged from 0 to 23. Each item of the TIS was tested three times and the highest score counted. No practice was allowed.
次要结局
- Pediatric Balance Scale(12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises in Patients With Myasthenia GravisMyasthenia GravisNCT06158815Hacettepe University23
已完成
不适用
Effects of PNF on Shoulder Pain in Paraplegic Manual Wheel Chair UsersShoulder ImpingementNCT04967911Riphah International University22
Unknown
不适用
The Effects of Proprioceptive Neuromuscular Facilitation and Static Stretching ExercisesFlexibilityNCT04026646Eastern Mediterranean University60
已完成
不适用
Effects of Cervical Proprioceptive Training in CMNPChronic Neck PainNCT04941495Mir Arif Hussain44
已完成
不适用
The Effects of Proprioceptive Neuromuscular Facilitation, Myofascial Releasing Maneuvers and Home Exercises on Pain and Jaw Function in Patients With BruxismExerciseMyofascialBruxismNCT03499665Inonu University52