NCT07764926

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

July 27, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Delayed Milestones, MNRI, Pediatrics,

Outcome Measures

Primary Outcomes (1)

  • Change in Sollerman Hand Function Test (SHFT) total score from baseline to 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.

    4 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

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

Other: MNRI

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

Other: Conventional Physiotherapy without MNRI

Interventions

MNRIOTHER

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.

MNRI Group

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.

control group without MNRI training

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (1)

  • Stivaros S, Garg S, Tziraki M, Cai Y, Thomas O, Mellor J, Morris AA, Jim C, Szumanska-Ryt K, Parkes LM, Haroon HA, Montaldi D, Webb N, Keane J, Castellanos FX, Silva AJ, Huson S, Williams S, Gareth Evans D, Emsley R, Green J; SANTA Consortium. Randomised controlled trial of simvastatin treatment for autism in young children with neurofibromatosis type 1 (SANTA). Mol Autism. 2018 Feb 22;9:12. doi: 10.1186/s13229-018-0190-z. eCollection 2018.

    PMID: 29484149BACKGROUND

MeSH Terms

Conditions

Learning DisabilitiesRadiation induced meningioma

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sonia Babar, MS-PT

    Riphah International University, Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single masking (participant): Participants were blinded to group allocation. The experimental and control groups were not disclosed to the participants to minimize bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 14, 2026

Study Start

May 11, 2026

Primary Completion

June 27, 2026

Study Completion

July 27, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations