MNRINCT07764926
Effects of MNRI Therapy on Fine Motor Skills in Children With Developmental Delays.
A study testing MNRI and Conventional Physiotherapy without MNRI in people with MNRI and Development Delay, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- MNRI, Development Delay
- What is being tested?
- MNRI and Conventional Physiotherapy without MNRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 11 May 2026to 27 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Masgutova Neurosensorimotor Reflex Integration Therapy on Fine Motor Skills Among 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.
Read the detailed description
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.
- Conditions
- MNRI, Development Delay
- Being tested
- MNRI, Conventional Physiotherapy without MNRI
- Keywords
- Delayed Milestones, MNRI, Pediatrics,
- Medical subject headings
- Learning Disabilities, Radiation induced meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional Physiotherapy without MNRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Conventional Physiotherapy without MNRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
Change in Reflex Assessment Scale (RAS) score from baseline to 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.
Measured: 4 weeks
Change in Pediatric Evaluation of Disability Inventory (PEDI) total score from baseline to 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.
Measured: 4 weeks
Change in Participation and Sensory Environment Questionnaire (PSEQ) total score from baseline to 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start11 May 2026
- Primary completion27 Jun 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MNRIStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Babar, MS-PT, Principal investigator, Riphah International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764926
- Sponsor's protocol ID
- REC/RCR&AHS/25/0719
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29484149
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Masgutova Neurosensorimotor Reflex Integration Therapy on Fine Motor Skills Among Children With Developmental Delays.
- ClinicalTrials.gov ID
- NCT07764926
- Acronym / sponsor ID
- REC/RCR&AHS/25/0719
- Conditions
- MNRI, Development Delay
- Keywords
- Delayed Milestones, MNRI, Pediatrics,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 27 Jun 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNRI Group | Experimental | Other: MNRIMasgutova 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 |
| control group without MNRI training | Other | Other: Conventional Physiotherapy without MNRIA 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 |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNRIParticipants 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. | Other | MNRI Group |
| Conventional Physiotherapy without MNRIParticipants 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. | Other | control group without MNRI training |
Primary outcome
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.
3 secondary outcomes
Change in Reflex Assessment Scale (RAS) score from baseline to 4 weeks
Time frame: 4 weeks
Change in Pediatric Evaluation of Disability Inventory (PEDI) total score from baseline to 4 weeks
Time frame: 4 weeks
Change in Participation and Sensory Environment Questionnaire (PSEQ) total score from baseline to 4 weeks
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 29484149Stivaros 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.
- Individual participant dataSharing planned: No
Related trials for MNRI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Babar, MS-PT principal investigator
Riphah International University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNRI and Conventional Physiotherapy without MNRI in people with MNRI and Development Delay, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sollerman Hand Function Test (SHFT) total score from baseline to 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.