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临床试验/NCT06522451
NCT06522451已完成不适用

Effects of Conventional Physical Therapy With and Without Cuevas Medek Exercises on Gross Motor Function in Children With Motor Developmental Delay

Riphah International University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月28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
24
试验地点
2
主要终点
Peabody Developmental Motor Scale

研究概览

简要总结

There are several etiologies for developmental delay (DD). One of the main causes of developmental delay is cerebral palsy (CP), which has a variety of clinical characteristics brought on by damage to the developing brain. Children with developmental delays frequently have difficulties with feeling, perception, cognition, communication, musculoskeletal disorders, and movement and posture. A child's developmental delay could be avoided and motor milestones could be reached with the help of a CME-based intervention. In order to lessen or prevent developmental motor delay, CME-based intervention may be taken into consideration as a research issue and as an option for either intensive or conventional therapy.

A randomized control trial will be used for this. The Sehat Medical Complex in Lahore's physiotherapy department would be the source of the data collection. This study includes children of any gender between the ages of 12 and 42 months. Babies with motor developmental delays are diagnosed and their treatment plans are developed using the Bayley Scales of Infants and Toddlers IV (BSID-4). Conventional physical treatment, including dynamic/static stretches, functional exercises, passive mobilizations, balance modulation, and gait training, was administered to group A. At baseline, the functional state of both groups will be evaluated. Treatment sessions will run for a total of 12 weeks, five days a week, for 45 minutes each. They will consist of four to six repeated exercises, six times on average, and will continue to use BSID-4 after the study is finished. Group B includes Cuevas Medak exercises like transition and head and trunk control (by stabilizing limb) and sitting-to-standing transition are recommended. For a duration of 12 weeks, five days a week, and 45 minutes, each session will be held. At baseline, the functional state of both groups will be evaluated. then once the sessions are over, more data will be gathered using BSID-4. This research will help determine the efficacy of CME therapy in addition to traditional physical therapy.

详细描述

Group A: Control Group: The only form of physical therapy (CPT) given to this group will be conventional CPT. These regular workouts will include dynamic and static stretching, walking-specific functional exercises, passive mobilizations for pain-free mobility, balance modulation, and gait training. At baseline, the functional state of both groups will be evaluated. Treatment sessions will run for a total of 12 weeks, five days a week, for 45 minutes each. They will consist of four to six repeated exercises, six times on average, and use BSID-4 once the trial is over.

Group B: Experimental Group: In addition to regular physical therapy, this group will also get Cuevas Medak exercises, such as head and trunk control (by stabilizing limb) and standing to sitting transition. For a duration of 12 weeks, five days a week, and 45 minutes, each session will be held. At baseline, the functional state of both groups will be evaluated. then once the sessions are over, more data will be gathered using BSID-4.

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 (Participant)

入排标准

年龄范围
1 Year 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with motor developmental delay will only be included, and it will be ruled out by using Portage's Guide.
  • Age between 12 and 42 months.
  • Both genders

排除标准

  • Individuals who suffer from particular neurological impairments, such as hydrocephalus, or who have related conditions.
  • Patients with systemic disorders, infectious diseases, or vision impairment will not be accepted.
  • Spinal surgery history

结局指标

主要结局

Peabody Developmental Motor Scale

时间窗: 12 weeks

Peabody Developmental Motor Scales (PDMS-2) is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age. This subtest measures aspects of a child's ability to automatically react to environmental events. Because reflexes typically become integrated by the time a child is 12 months old, this subtest is given only to children ages 2 weeks through 11 months. It measures a child's ability to sustain control of the body within its center of gravity and retain equilibrium

Bayley Scales of Infant and toddler Development IV

时间窗: 12 weeks

The Bayley scales of infants and toddlers IV (BSID-4) is an individually administered instrument that evaluates the developmental functioning of infants and young children between the ages of one and forty-two months. There are two ways to administer the BSID-4: the Social-Emotional and Adaptive Behavior scales, which is a questionnaire that parents or caregivers complete, and the Cognitive, Language, and Motor scales, which are administered by a qualified professional and scored through observation and direct interaction with the child. To obtain qualitative information about motor skills (e.g., attends to the examiner on camera, shifts attention when name is called, babbles, reaches and groups objects), the BSID-4 contains 56 items in the gross motor domain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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