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临床试验/NCT07764926
NCT07764926已完成不适用

Effects Of Masgutova Neurosensorimotor Reflex Integration Therapy on Fine Motor Skills Among Children With Developmental Delays.

Riphah International University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年5月11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
34
试验地点
1
主要终点
Change in Sollerman Hand Function Test (SHFT) total score from baseline to 4 weeks

研究概览

简要总结

Developmental delay refers to a child's failure to achieve age-appropriate developmental milestones and may affect multiple developmental domains. MNRI (Masgutova Neurosensorimotor Reflex Integration) therapy is designed to improve sensory-motor integration, motor coordination, and cognitive function in children with neurodevelopmental disorders by integrating impaired reflex pathways. This randomized clinical trial will be conducted at Children Complex Hospital on 34 participants divided into experimental and control groups. The experimental group will receive MNRI therapy, while the control group will receive standard care. Reflex integration and upper limb fine motor skills will be assessed over six months, and data will be analyzed using IBM SPSS Statistics.

详细描述

Delay in development is generally determined with a child does not attain developmental milestones as compared to peers from the same population. "Developmental delay" is a general descriptor of a broad phenotype that must then be specified by carefully determining one or more elements linked with the area of disrupted development. Developmental delay is not a diagnosis by itself rather a categorical, illustrative term used in the clinic. Further, the terms often used to specify a developmental delay may vary by country or area of practice. For example, the term "mental retardation is no longer in use with "learning disability" being used in the UK and Intellectual Disability being used in the US to define a group of individuals with a significant delay defined by "performance equal or greater than two standard deviations below the mean on age-appropriate standardized norm-referenced testing" (IQ or intelligent quotient testing). The MNRI (Masgutova Neurosensorimotor Reflex Integration) processes are designed for individuals with neuro-developmental disorders and aimed at the improvement of their sensory-motor integration, motor coordination, and cognitive development. The MNRI therapy program is based on the supposition that impaired reflex circuits can be reconstructed.

A randomized clinical trial will be conducted at Children Complex Hospital in Multan. Non probability convenience sampling technique will be applied on 34 patients who will be allocated through simple random sampling into group A & group B to collect data. Group A will be given Masgutova Neurosensorimotor Reflex Integration therapy (MNRI) and group B will be a control group. The study will be completed within the time duration of six months .Primary Outcome measures of the research will be reflexes and fine motor skills of upper limbs. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

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)

盲法说明

Single masking (participant): Participants were blinded to group allocation. The experimental and control groups were not disclosed to the participants to minimize bias.

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of 2-6 years of age presenting with development delay.
  • Severity of development delay in each domain will be labeled as mild, moderate and severe categories according to Denver Developmental Scale-II .
  • Children showing signs of unintegrated primitive reflexes (e.g., Moro, ATNR, STNR, TLR, etc.), which MNRI specifically targets.

排除标准

  • History of orthopedic surgery within the last half a year
  • Any other neurological or musculoskeletal disorders that might hamper the study's results (e.g., traumatic brain disorders, muscular dystrophy, and epilepsy).
  • Patients with autism and non-cooperative for development assessment.
  • Children whose development level was above 8 years of age as Griffith scale measures development age only up to 8 years .

研究组 & 干预措施

MNRI Group

Experimental

Masgutova Neurosensorimotor Reflex Integration (MNRI) therapy is a neurodevelopmental intervention designed to improve reflex integration, sensory-motor coordination, and fine motor functioning in children with developmental delays through structured reflex-based therapeutic exercises by using Reflex assessment scales Fine motor skill assessment of upper limbs Standardized developmental assessment tools/questionnaires Statistical analysis using IBM SPSS Statistics

干预措施: MNRI (Other)

control group without MNRI training

Other

A standardized physical treatment regimen was provided (Stretching exercise, Strengthening exercise, and facilitation of developing motor milestones) for the body.

Static stretches will be given. Strengthening exercises using resistance bands or light weights

干预措施: Conventional Physiotherapy without MNRI (Other)

结局指标

主要结局

Change in Sollerman Hand Function Test (SHFT) total score from baseline to 4 weeks

时间窗: 4 weeks

Fine motor function will be assessed using the Sollerman Hand Function Test (SHFT), a standardized 20-task assessment of hand function during activities of daily living. The total SHFT score ranges from 0 to 80, with higher scores indicating better hand function and manual dexterity. The primary outcome will be the change in total SHFT score from baseline to the end of the 4-week intervention.

次要结局

  • Change in Reflex Assessment Scale (RAS) score from baseline to 4 weeks(4 weeks)
  • Change in Pediatric Evaluation of Disability Inventory (PEDI) total score from baseline to 4 weeks(4 weeks)
  • Change in Participation and Sensory Environment Questionnaire (PSEQ) total score from baseline to 4 weeks(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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