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临床试验/NCT04907448
NCT04907448已完成不适用

Optimization of Weight-bearing- and Walking-symmetry and Dynamic Balance Using an Isokinetic Strength Training Protocol in Children With Hemiparetic Cerebral Palsy

Cairo University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年12月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Weight-bearing symmetry

研究概览

简要总结

This study endeavored to assess the effect of an isokinetic strength training (IsoK-ST) program on weight-bearing symmetry, gait-symmetry, and dynamic balance in children with hemiparetic cerebral palsy (HCP). Thirty-six children with HCP were randomly allocated to the IsoK-ST group (n = 18, received their usual physical rehabilitation program plus an IsoK-ST program) or the Control group (n =18, received usual physical rehabilitation alone). Both groups were assessed for weight-bearing symmetry, gait-symmetry, and dynamic balance before and after treatment.

详细描述

Thirty-six children with HCP were recruited from the Physical Therapy Outpatient Clinic of Collee 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 8 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had structural nonreducible deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, sensory-perceptual disorders, unstable convulsions, cardiopulmonary problems preventing them from performing high-intense exercise training.

Outcome measures

  1. Weight-bearing symmetry index: The weight-bearing symmetry index for the rearfoot and forefoot segments were assessed through a pressure analysis system
  2. Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAIT Rite system.
  3. Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.

The IsoK-ST and control groups received their usual physical rehabilitation program for 45 minutes, three times a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The IsoK-ST consisted of 3 sets (5-10 repetitions) of maximal concentric contraction of knee extensors and flexors on the affected side at angular speeds of 90, 120, 180, and 240 deg./sec., with intervals of rest for two minutes after each selected speed. The IsoK-ST workout was proceeded by a 5-minute warm-up and ended up with a 5-minute cool-dowm.

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
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Hemiparetic cerebral palsy
  • •Age 8-16 years
  • •Motor function level I or II according to the Gross Motor Function Classification System.
  • •Spasticity level 1 or 1+ according to the Modified Ashworth Scale

排除标准

  • •Structural deformities
  • •Musculoskeletal or neural surgery in the last year
  • •BOTOX injection in the last 6 months.
  • •Cardiopulmonary disorders interfering with the ability to engage in exercise training.
  • •Hemispatial neglect.

研究组 & 干预措施

IsoK-ST group

Experimental

Participants in this group received the usual physical rehabilitation program in addition to an IsoK-ST program.

干预措施: Physical Therapy (Other)

Control group

Active Comparator

Participants in this group received the usual physical rehabilitation program only.

干预措施: Physical Therapy (Other)

结局指标

主要结局

Weight-bearing symmetry

时间窗: 2 months

The weight-bearing symmetry indices of the rearfoot and forefoot segments were measured using a Pressure analysis system.

Gait-symmetry indices

时间窗: 2 months

Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through the portable GAIT Rite system

Dynamic balance

时间窗: 2 months

The directional (forward, backward, paretic, and non-paretic) and overall dynamic limits of stability were assessed through the Biodex balance system.

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

Assistant Professor

Cairo University

研究点 (1)

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