| 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
|
|
|
Primary Sponsor
|
| Name |
Anamika |
| Address |
S G T University Gurugram Haryana 122505 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
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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.
|
|
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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 H01– There 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 H01– There 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. |