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CTRI Number  CTRI/2025/06/089871 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 29/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Improving Hand Function and Brain Activity in Children with Spastic Cerebral Palsy using Mirror Therapy and Modified Constraint-Induced Movement Therapy. 
Scientific Title of Study   Comparative Analysis of mirror therapy and Modified Constrained Induced Movement Therapy (mCIMT) on upper limb function and brain recognition in children with spastic cerebral palsy. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anamika 
Designation  MPT student 
Affiliation  SGT university Gurugram Haryana 122505 
Address  Faculty of Physiotherapy, SGT university Gurugram Haryana

Gurgaon
HARYANA
122505
India 
Phone  7827021086  
Fax    
Email  anamikaphysiopt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurabh kumar 
Designation  Assosiate Professor 
Affiliation  S G T university Gurugram Haryana 122505 
Address  Faculty of Physiotherapy , S G T university Gurugram Haryana

Gurgaon
HARYANA
122505
India 
Phone  0  
Fax    
Email  saurabh_fpt@stuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Dr Saurabh kumar 
Designation  Assosiate Professor 
Affiliation  S G T university Gurugram Haryana 122505 
Address  Faculty of Physiotherapy , S G T university Gurugram Haryana

Gurgaon
HARYANA
122505
India 
Phone  0  
Fax    
Email  saurabh_fpt@stuniversity.org  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Anamika 
Address  S G T University Gurugram Haryana 122505 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Km Anamika  S G T medical college  room no 13, faculty of physiotherapy , S.G.T university gurugram Haryana 122505
Gurgaon
HARYANA 
7827021086

anamikayadavpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Istitutional ethical committee Faculty of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  mCIMT   Week 1 (3 sets x 10 reps each) a) Transferring small objects with a spoon b) Performing button closures c) Keyboard strokes d) Hitting a balloon with a gap bar Week 2 (3 sets x 12 reps each) a) Building a stuffed animal b) Playing with water pistols c) Card and puzzle games d) Picking and collecting small objects Week 3 & 4 (4 sets x 10 reps each) a) Weight transfer exercises b) Upper limb grasping tasks c) Reaching and release exercises d) Bubble popping activity Week 5 (4 sets x 12 reps each) a) Pegboard exercises (picking and placing small objects) b) Opening and closing clothespins with fingers c) Wrist and finger strengthening with resistance bands d) Shoulder mobility exercises with theraband Week 6 (5 sets x 10 reps each) a) Functional task training (buttoning a shirt, using utensils) b) Stacking cups or blocks c) Fine motor skill drills (finger tapping, handwriting) d) Hand-eye coordination games (target throwing, pegboard tasks) 
Intervention  Mirror therapy  Week 1 (3 sets x 10 reps each) a) Ball and elastic band exercises b) Picking up tennis balls and dropping them in a basket c) Rolling a tennis ball on a table d) Rowing with an elastic band Week 2 (3 sets x 12 reps each) a) Connecting the dots on paper b) Snipping cardboard c) Rotating the shoulder wheel d) Wiping a table with a cloth Week 3 & 4 (4 sets x 10 reps each) a) Forearm pronation and supination b) Wrist and finger flexion-extension c) Squeezing a stress ball d) Thumb opposition exercises Week 5 (4 sets x 12 reps each) a) Pegboard exercises (picking and placing small objects) b) Opening and closing clothespins with fingers c) Wrist strengthening with resistance bands d) Shoulder external and internal rotation with theraband Week 6 (Functional tasks, 3-5 reps per task) a) Functional task training (buttoning a shirt, using utensils) b) Stacking cups or blocks c) Finger tapping and dexterity drills d) Handwriting and fine motor skill activities 
 
Inclusion Criteria  
Age From  8.00 Day(s)
Age To  16.00 Day(s)
Gender  Both 
Details  1.Diagnoses with spastic hemiplegic CP
2.Aged 8 to 16 years old
3.Able to follow instructions and complete testing
4.To sit without supervision, cognitive and verbal abilities (attention, working memory, and concentration)
5.Spasticity grade 1 or 1+ based on the Modified Ashworth Scale
6.Were not having incurable vision or hearing problems

 
 
ExclusionCriteria 
Details  1.Diagnosed with mental retardation
2.Botulinum neurotoxin A injections in the previous
3.6 months or planned within the following 6 months;
4.Orthopedic surgery in the previous 12 months or planned within the study period; and
5.Orthopedic surgery or botulinum neurotoxin A injection in the involved upper limb during the past 6 months
6.Congenital deformity of upper limb
7.Previous surgery or pain in upper limb, vision problem, epilepsy, heart and respiratory problem.
8.Previous surgery or pain in the upper limbs, vision problems, epilepsy, heart, and respiratory problems
9.Any other musculoskeletal problems that prevent the participants from doing resistance training.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
upper limb coordination test, muscle tone, coginition test, upper limb functional test  assessmet and intervention from 1 week to 6 week. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cerebral palsy (CP) is a group of permanent movement and posture disorders caused by non-progressive brain disturbances in fetal or infant development . It results from damage to the developing brain, often before or during birth, and manifests in various forms, including spasticity (muscle stiffness), dyskinesia (involuntary movements), and ataxia (poor coordination). CP can also lead to cognitive, communication, and behavioral challenges. While the severity varies among individuals, early intervention and therapy improve quality of life.CP is commonly associated with sensory, perceptual, and musculoskeletal issues, epilepsy, and secondary complications. Its prevalence is approximately 2.08 per 1,000 live births in Europe, with a significantly higher incidence in low-birthweight infants . Prematurity and low birth weight are major risk factors, although many cases occur in full-term infants without known causes .Both genetic and environmental factors contribute to CP. While genetic predisposition can lead to brain abnormalities, environmental influences such as prenatal infections, birth complications, and postnatal brain injuries also play critical roles. The interplay of these factors shapes the condition’s development .Despite being non-progressive, CP symptoms can evolve over time. The condition can arise at different stages—prenatal, perinatal, or postnatal—when the brain is highly susceptible to damage. Early detection and rehabilitation are essential for optimizing motor function and overall development .Treatment focuses on therapy to enhance mobility and function. Mirror therapy, which tricks the brain into perceiving movement in an impaired limb through a mirror reflection, is effective for hand and arm rehabilitation. Research is ongoing to explore its potential for other body parts .Constraint-Induced Movement Therapy (CIMT) is another rehabilitation technique that encourages the use of an affected limb by restricting the stronger one. A modified version (mCIMT) helps individuals with developmental disregard regain function through structured exercises, improving motor control and brain adaptability.Advances in neuroscience, particularly in brain recognition techniques, have led to breakthroughs in understanding neurological function and dysfunction. Research in this field has facilitated the development of innovative therapies, brain-computer interfaces, and AI-driven neurological interventions .Although CP remains a lifelong condition, continued advancements in therapy and rehabilitation offer promising improvements in mobility and overall quality of life.

Null Hypothesis

H01There will not be  significant effect of mirror therapy on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone on spastic cerebral palsy.

H02 There will not be  significant effect of mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy

H03 - There will not be  significant effect of Mirror therapy and mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy

Alternate Hypothesis

H1 -There will be significant effect of mirror therapy on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy.

H2 There will  be  significant effect of mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy

H3 - There will be  significant effect of Mirror therapy and mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy.

Null Hypothesis

H01There will not be  significant effect of mirror therapy on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone on spastic cerebral palsy.

H02 There will not be  significant effect of mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy

H03 - There will not be  significant effect of Mirror therapy and mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy

Alternate Hypothesis

H1 -There will be significant effect of mirror therapy on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy.

H2 There will  be  significant effect of mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy

H3 - There will be  significant effect of Mirror therapy and mCIMT on coordinate movement both  hands , coordination in the upper limb extremities, Visual motor control and Muscle tone  on spastic cerebral palsy.


 
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