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Completed

NCT Number: NCT07764926

Effects of MNRI Therapy on Fine Motor Skills in Children With Developmental Delays.

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 .

Treatment and study plan

MNRI

Other

Participants will receive Masgutova Neurosensorimotor Reflex Integration (MNRI) therapy administered by trained physiotherapists for 45-60 minutes per session, 5 days per week, for 4 weeks. Sessions will begin with stretching and strengthening exercises, followed by reflex integration activities targeting Moro, ATNR, STNR, TLR, and Spinal Galant reflexes through exercises such as Starfish, Cat-Cow, Cross Crawl, rocking, crawling, and proprioceptive activities. Upper limb training will include hand and wrist activation, proprioceptive stimulation, gripping activities, forearm activation, and grasp pattern exercises to improve fine motor skills and reflex integration.

Conventional Physiotherapy without MNRI

Other

Participants will receive a standardized conventional physiotherapy program administered by trained physiotherapists. The program will include stretching exercises for the upper and lower limb muscles, including static stretching of tight muscle groups, strengthening exercises using resistance bands or age-appropriate light weights, facilitation and practice of age-appropriate developmental motor milestones such as rolling, sitting, crawling, standing, walking, balance, and transitional movements, as well as functional upper limb activities to improve reaching, grasping, and object manipulation. Gross motor training will be individualized according to each child's developmental level. The intervention will be provided for 45-60 minutes per session, 5 days per week for 4 weeks.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Change in Reflex Assessment Scale (RAS) score from baseline to 4 weeks

    Time frame: 4 weeks

    Primitive reflex integration will be evaluated using the Reflex Assessment Scale (RAS). The outcome will be the change in total RAS score from baseline to 4 weeks. Lower scores indicate greater reflex integration.

  2. Change in Pediatric Evaluation of Disability Inventory (PEDI) total score from baseline to 4 weeks

    Time frame: 4 weeks

    Functional performance and independence in activities of daily living will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI). The outcome will be the change in total PEDI score from baseline to 4 weeks. Higher scores indicate better functional ability.

  3. Change in Participation and Sensory Environment Questionnaire (PSEQ) total score from baseline to 4 weeks

    Time frame: 4 weeks

    Participation and the impact of sensory environments will be assessed using the Participation and Sensory Environment Questionnaire (PSEQ). The outcome will be the change in total PSEQ score from baseline to 4 weeks. Lower scores indicate fewer sensory-related participation difficulties.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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