| CTRI Number |
CTRI/2025/06/088306 [Registered on: 05/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study to See What Helps Kids with Movement Problems on One Side Use Their Arms Better, Special Training for the Weaker Arm or Making the Stronger Arm Stronger |
|
Scientific Title of Study
|
Evaluating the impact of modified constraint-induced movement therapy versus strengthening of the unaffected upper limb on upper extremity function in children with hemiplegic cerebral palsy: A quasi-experimental study. |
| 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 Bhakti Ladha |
| Designation |
PG Student |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no. 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9067582047 |
| Fax |
|
| Email |
bhaktiladha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Palaskar |
| Designation |
Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no. 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9604487807 |
| Fax |
|
| Email |
pallavi.palaskar@mgmsop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Palaskar |
| Designation |
Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no. 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9604487807 |
| Fax |
|
| Email |
pallavi.palaskar@mgmsop.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of neuro physiotherapy no. 5 MGM School of Physiotherapy, N6 Cidco Aurangabad
431001, maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
Department of neuro physiotherapy no. 5 MGM School of
Physiotherapy, N6 Cidco Aurangabad 431001, maharashtra, India |
| 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 |
| Dr Bhakti Ladha |
MGM School of Physiotherapy |
MGM School of
physiotherapy, Neuro
OPD room number 5 , C
building N6 Cidco
Chhatrapati
Sambhajinagar
Maharashtra 431001,
India
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
9067582047
bhaktiladha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics committee for Research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Constraint-Induced Movement Therapy (MCIMT) with Standardized therapy |
The Modified Constraint-Induced Movement Therapy (MCIMT) will include immobilization of the unaffected limb. A mitt or sling is placed on the unaffected upper limb to prevent its use, making the affected limb the focus of activity with a frequency of 2 hours. Task-Specific Training: Repetitive functional tasks such as grasping, releasing, and manipulating objects. Examples: Pick and Place, Shaping, Stacking Blocks. Functional Movement Integration: Drawing, rubber band stretching with fingers, moving water from one cup to another.
The standardized therapy will include bimanual hand coordination exercises: lifting objects with both hands, tying shoelaces, clapping hands, tearing paper, and opening and closing bottles. Posture and Balance Training: Cat-Cow Stretch, Single-Leg Stance, gait training with obstacles, and walking up and downstairs with 1–3 sets of 8–12 repetitions.
Dexterity and Fine Motor Skill Enhancement: Finger Tapping, Pincer Grasp Tasks, Paper Folding. Sensory Integration: Texture Exploration and Object Manipulation.
|
| Comparator Agent |
Strengthening of Unaffected Upper Limb with Standardized therapy |
The strengthening of the unaffected upper limb will include functional movement integration: Drawing, rubber band stretching with fingers, moving water from one cup to another. Resistance-Based Strengthening:
Equipment: TheraBand & Thera putty
Exercises: – Shoulder flexion, extension, abduction, and adduction Elbow flexion and extension Forearm pronation and supination 17
Reps: 6-10 per set 18
Full Grip, Finger Pinch, Finger Scissor: 10 times for two sets.
Shoulder Girdle Strengthening: Shoulder shrugs, wall pushups, shoulder retraction, and protraction.
The standardized therapy will include bimanual hand coordination exercises: lifting objects with both hands, tying shoelaces, clapping hands, tearing paper, and opening and closing bottles. Posture and Balance Training: Cat-Cow Stretch, Single-Leg Stance, gait training with obstacles, and walking up and downstairs with 1–3 sets of 8–12 repetitions.
Dexterity and Fine Motor Skill Enhancement: Finger Tapping, Pincer Grasp Tasks, Paper Folding. Sensory Integration: Texture Exploration and Object Manipulation.
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with hemiplegic cerebral palsy
Children of both genders
Age between 8 and 12 years
Ability to understand and follow simple instructions
|
|
| ExclusionCriteria |
| Details |
Severe cognitive impairments preventing participation by using Montreal cognitive assessment
Coexisting neuromuscular conditions other than cerebral palsy
Behavioral issues interfering with adherence to therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bimanual Fine Motor Function
Manual Ability Classification System |
Baseline pre-intervention and 4 weeks post-intervention
Baseline pre-intervention and 4 weeks post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pediatric Quality of Life Inventory (PedsQL)
Pediatric Evaluation of Disability Inventory (PEDI) |
Baseline pre-intervention and 4 weeks post-intervention.
Baseline pre-intervention and 4 weeks post-intervention. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/06/2025 |
| 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="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
|
The aim of the study is to compare the
effectiveness of Modified Constraint-Induced Movement Therapy (MCIMT) versus strengthening
exercises for the unaffected upper limb on improving upper extremity function in
children with hemiplegic CP. The objectives of the study are 1.
To evaluate the impact of MCIMT on upper
extremity function, bimanual hand skills, QOL, and ADLs in children with hemiplegic
cerebral palsy.
2.
To assess the role of strengthening exercises
for the unaffected upper limb on upper extremity function, bimanual hand
skills, QOL, and ADLs in children with hemiplegic cerebral palsy.
3.
To compare the effects of Modified Constraint-Induced
Movement Therapy (MCIMT) and strengthening exercises on bimanual hand skills,
upper extremity function, QOL, and ADLs for children with hemiplegic cerebral palsy.
|