| CTRI Number |
CTRI/2026/02/103377 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Proprioceptive Neuromuscular Facilitation(PNF) combined with Conventional Physiotherapy on Hand-Eye Coordination and Upper Limb Function in Children with Cerebral Palsy |
|
Scientific Title of Study
|
Added Effect of Proprioceptive Neuromuscular Facilitation(PNF) along with Conventional Physiotherapy on Hand-Eye Coordination and Upper Limb Function in Children with 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 |
Dr Deepashree Kulkarni PT |
| Designation |
MPTh student |
| Affiliation |
MAEERS Physiotherapy College, Talegaon Dabhade, Maval, Pune. |
| Address |
A-230,Neurphysiotherapy OPD, MAEERS Physiotherapy College,2nd floor, OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra.
Pune
MAHARASHTRA
410507
India |
| Phone |
7208589313 |
| Fax |
|
| Email |
deepashree14april@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra Sakhawalkar |
| Designation |
Associate Professor |
| Affiliation |
MAEERS Physiotherapy College, Talegaon Dabhade, Maval, Pune. |
| Address |
A-230,Neurphysiotherapy OPD, MAEERS Physiotherapy College,2nd floor, OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra.
A-230,Neurphysiotherapy OPD, MAEERS Physiotherapy College,2nd floor, OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra.
Pune
MAHARASHTRA
410507
India |
| Phone |
9049998861 |
| Fax |
|
| Email |
sumitra26@mitmimer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepashree Kulkarni PT |
| Designation |
MPTh student |
| Affiliation |
MAEERS Physiotherapy College, Talegaon Dabhade, Maval, Pune. |
| Address |
A-230,Neurphysiotherapy OPD, MAEERS Physiotherapy College,2nd floor, OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra.
A-230,Neurphysiotherapy OPD, MAEERS Physiotherapy College,2nd floor, OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra.
Pune
MAHARASHTRA
410507
India |
| Phone |
7208589313 |
| Fax |
|
| Email |
deepashree14april@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurophysiotherapy OPD,MAEERS Physiotherapy College, 2nd floor, OPD Building, Talegaon Dabhade, Maharashtra 410507 |
|
|
Primary Sponsor
|
| Name |
Dr Deepashree Sandeep Kulkarni PT |
| Address |
A-230, Neurophysiotherapy OPD, MAEERS Physiotherapy College, Dr. BSTR Hospital, 2nd floor, OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra, 410507 |
| Type of Sponsor |
Other [Self Financed] |
|
|
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 |
| Dr Deepashree Kulkarni |
MAEERS Physiotherapy College, Dr. BSTR Hospital |
A-230, Neurophysiotherapy OPD, MAEERS Physiotherapy College, Dr. BSTR Hospital, 2nd floor, OPD Building, near MIMER Medical College Campus, Talegaon Station Rd, Talegaon Dabhade, Maharashtra, 410507
Pune
MAHARASHTRA |
7208589313
deepashree14april@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS Physiotherapy College, Approved Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80-G83||Cerebral palsy and other paralytic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy. |
Conventional Physiotherapy Components:
Supine trunk exercises (upper and lower trunk rotations, pelvic bridging, trunk flexion with rotation)
Training of righting and equilibrium reactions
Balance training using balance board and Swiss ball
Target-oriented upper limb activities integrated with trunk control exercises
Standing trunk exercises with functional upper limb tasks
Dosage:
Frequency: 3 sessions per week
Duration: 4 weeks
Intensity and repetitions progressed weekly (5 to 20 repetitions)
Both groups will receive therapy for an equal duration and frequency to maintain treatment equivalence, except for the additional PNF techniques in the intervention group. |
| Intervention |
Proprioceptive Neuromuscular Facilitation (PNF) techniques in addition to conventional physiotherapy. |
Proprioceptive Neuromuscular Facilitation: Target area-Trunk and proximal musculature to enhance postural control and stability for upper limb function
Techniques used:
Rhythmic Stabilization
Combination of Isotonics
Resisted concentric and eccentric trunk movements (supine to sitting and sitting to supine)
Lifting patterns (bilateral and unilateral)
Bilateral lower extremity extension patterns for lower trunk extension
Dosage:
Frequency: 3 sessions per week
Duration: 4 weeks
Repetitions: Gradually progressed from 5 to 20 repetitions based on weekly protocol
Therapist: Trained physiotherapist under supervision of the guide
Setting: OPD/special school physiotherapy setup on a soft mat with appropriate safety measures
The PNF protocol is designed to facilitate proprioceptive input, improve trunk stability, and thereby enhance hand-eye coordination and upper limb function. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with Spastic Cerebral Palsy-
-Between 3 to 18 years.
-Manual Ability Classification System(MACS) level I and II.
-Trunk Control Measurement Scale (TCMS) score between (25-42).
-Visual Function Classification System (VFCS) level I,II and III. |
|
| ExclusionCriteria |
| Details |
Children’s diagnosed with-
-Dyskinetic and ataxic CP
-Orthopaedic procedure of upper limb and trunk within 6 months.
-Botox injection within 6 months.
-Uncontrolled Epilepsy within 6 months.
-Mental Retardation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hand- Eye Coordination assessed using: Purdue- Peg Board and COGNIFIT Software.
2.Upper limb function assessed using: ABIL-Hand KIDS Scale.
|
T0- Baseline (Before initiation of intervention).
T1- At the end of 4 weeks intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements in Trunk Control Assessed using: Trunk Control Measurement Scale (TCMS). |
T0- Baseline (Before initiation of intervention).
T1- At the end of 4 weeks intervention. |
|
|
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)
|
20/02/2026 |
| 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="1"
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 non-progressive neurodevelopmental disorder defined by impairments in movement and posture resulting in difficulties in upper limb function and hand-eye coordination. Poor trunk control and inadequate activation of trunk extensor muscles adversely affect reaching activities and functional use of the upper limbs in children with CP. Conventional physiotherapy focuses on trunk strengthening, balance training, and postural control; however, evidence regarding improving of hand-eye coordination through improved trunk stability remains limited. This experimental study aims to asses the added effect of Proprioceptive Neuromuscular Facilitation (PNF) combined with conventional physiotherapy compared to conventional physiotherapy alone on hand-eye coordination and upper limb function in children with cerebral palsy. A total of 40 children aged 3–18 years diagnosed with cerebral palsy will be recruited from hospital OPDs and special schools and randomly allocated into two groups. Group A will receive conventional physiotherapy, while Group B will receive PNF along with conventional physiotherapy for 4 weeks (3 sessions/week). Hand-eye coordination will be assessed using the Purdue Pegboard Test and CogniFit software, upper limb function using the ABILHAND-Kids scale additionally trunk control using the Trunk Control Measurement Scale (TCMS).Pre- and post-intervention outcomes will be analyzed using appropriate parametric or non-parametric statistical tests. The findings of this study may provide evidence for integrating PNF techniques into rehabilitation programs to enhance trunk control, hand-eye coordination, and functional upper limb performance in children with cerebral palsy.
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