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临床试验/NCT05198999
NCT05198999已完成不适用

Aquatic-based Plyometric Exercises for Children With Hemiparetic Cerebral Palsy: A Randomized Controlled Study Investigating Effects on Postural Control and Functional Performance

Cairo University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Gait balance

研究概览

简要总结

This study was designed to assess the effect of a 12-week aquatic-based plyometric (Aqua-PLYO) training on postural control and functional performance in children with hemiparetic cerebral palsy (h-CP). Fifty-six children with h-CP were randomly allocated to the Aqua-PLYO group (n = 28, received an Aqua-PLYO training program, trice/week, over 12 weeks) or the control group (n =28, received standard rehabilitation). Both groups were assessed for postural control and functional performance pre and post-treatment.

详细描述

Fifty-six children with h-CP were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 12 and 16 years, were functioning at levels I or II on the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, had leg-length discrepancy, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, attentional neglect, cardiopulmonary problems preventing them from performing high-intense exercise training.

Outcome measures

  1. Postural control: The dynamic limits of stability (LOSdynamic) indices were measured through the Balance Master system.
  2. Functional performance: Functional performance was quantified using the 30-second sit-to-stand test (30sec-STS), Timed Up and Down Stairs test (TUDS), and the Dynamic Gait Index (DGI).

The Aqua-PLYO group received a 12-week Aqua-PLYO training, 45 minutes per session, three times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The Aqua-PLYO program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. The Aqua-PLYO training included a warm-up for 10 minutes and a cool-down for10 minutes. The control group received the usual physical therapy care, 45 minutes per session, three times a week for 12 consecutive weeks. The program consisted of advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.

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

This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Hemiparetic cerebral palsy
  • Age between 12 to 16 years
  • Spasticity level 1 or 1+ according to the Modified Ashworth Scale
  • Gross motor function level I or II according to the Gross Motor Function Classification System

排除标准

  • Structural deformities
  • Musculoskeletal or neural surgery in the last year
  • BOTOX injection in the last 6 months.
  • Cardiopulmonary disorders limit the ability to engage in explosive exercise training
  • Hemi-spatial neglect

结局指标

主要结局

Gait balance

时间窗: 2 months

Gait balance was measured by the Dynamic Gait Index. The dynamic gait index quantified the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. The index includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score is 24. Higher scores mean a better outcome.

Maximum Excursion

时间窗: 2 months

The distance, the subject actually covered or moved his center of gravity toward a target, expressed as a percentage (%) of the dynamic limit of stability

Movement Velocity

时间窗: 2 months

The average speed at which the center of gravity shifts, measured in degree/second

Functional mobility

时间窗: 2 months

Functional mobility was assessed by Timed Up and Down Stairs test. the test measures the time (second) that the subject takes to go upstairs, turn around, and come back down. Shorter time indicates better performance.

Reaction time

时间窗: 2 months

The time, taken by an individual to start shifting his center of gravity from the static position after the cue, measured in seconds

EndPoint Excursion

时间窗: 2 months

The distance willingly covered by the subject in his very first attempt towards the target, expressed as a percentage (%)

Functional lower limb strength

时间窗: 2 months

the functional strength of lower limbs was measured by the 30-second sit-to-stand test. The test determines the number of sit-to-stand task repetitions performed within 30 seconds. The higher number of repetitions indicates better performance.

Directional Control

时间窗: 2 months

The amount of movement demonstrated in the desired direction, i.e. towards the target, to the amount of external movement in the opposite direction of the target, expressed as a percentage.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ragab Kamal Elnaggar

Associate Professor

Cairo University

研究点 (1)

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