| CTRI Number |
CTRI/2024/07/071625 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| 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
|
Comparison between mCIMT and Bimanual Therapy on the functions of the upper limb in children with cerebral palsy |
|
Scientific Title of Study
|
A comparative analysis of effectiveness of mcimt over bimanual therapy on the upper limb functions in children with hemiplegic 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 |
Shamama Athar |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise Therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road,, Bardhaman, West Bengal, 713104
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9123108646 |
| Fax |
|
| Email |
shamamalife@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanima Bhattacharyya |
| Designation |
Assistant Professor |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise Therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road,, Bardhaman, West Bengal, 713104
Barddhaman
WEST BENGAL
713104
India |
| Phone |
7980327762 |
| Fax |
|
| Email |
tanimabhattacharyya2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajnee Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise Therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road,, Bardhaman, West Bengal, 713104
Barddhaman
WEST BENGAL
713104
India |
| Phone |
8697568628 |
| Fax |
|
| Email |
rajnee08mishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, Bardhaman,713104 |
|
|
Primary Sponsor
|
| Name |
Shamama Athar |
| Address |
Exercise Therapy Lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, University Road, Golapbag, Bardhaman, West Bengal, 713104, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Shamama Athar |
Burdwan Institute of Medical and LIfe Sciences |
Exercise Therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road,, Bardhaman, West Bengal, 713104
Barddhaman
WEST BENGAL |
9123108646
shamamalife@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Burdwan Institute of Medical and Life Sciences Bardhaman India |
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 |
| Comparator Agent |
Bimanual Therapy |
Bimanual therapy is a specialized rehabilitation approach designed to improve the functional abilities of individuals, particularly children, with cerebral palsy. Bimanual therapy focuses on enhancing the coordination and integration of both hands simultaneously to promote independence and participation in various tasks. Bimanual therapy typically involves a combination of therapeutic activities and exercises tailored to the individual needs and abilities of the child. It will be given for 2 hours 30 minutes per day, 3 sessions in a week for 10 weeks |
| Intervention |
Modified Constraint Induced Movement Therapy |
It has emerged as a main treatment approach for children with CP. As the clinical use of mCIMT in children continues to grow, additional studies are needed to determine how basic parameters of the therapy affect outcomes. The application of modified (less frequent and more prolonged) constraint programmes (mCIMT) for young children seems more child friendly. It will be given for 2 hours 30 minutes per day per , 3 sessions in a week for 10 weeks. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed as CP child with hemiplegia
2. Able to follow verbal instructions |
|
| ExclusionCriteria |
| Details |
1. Children with uncontrolled and recent epileptic seizures
2. Children with diplegia, quadriplegia
3. Children with Athetoid CP
4. Children with muscle contracture
5. Upper limb bone deformity
Children with diagnosed ASD and ADHD
6. Have undergone any surgical procedure of upper limb
7. Unhealed fracture of upper limb |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MACS(MANUAL ABILITY CLASSIFICATION SYSTEM) |
The MACS scale will be measured on the 1st day of treatment and after completion of 10 weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QUEST(Quality of Upper Extremity Skill test) |
1st day of treatment and after 10 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
02/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction: Cerebral palsy (CP)
is a neurological disorder that affects movement, muscle tone, and posture. It
is caused by damage to the developing brain, usually before or during birth.
This damage disrupts the brain’s ability to control movement and posture,
leading to difficulties in coordination, balance, and motor skills. The
severity of cerebral palsy can vary widely from person to person. While some
individuals may have only minor difficulties with movement, others may be
severely affected and require extensive assistance with daily activities.. Motor function
disorders, which are the core symptoms of cerebral palsy, are frequently
accompanied by other dysfunctions, such as: sensation, perceptual, cognitive,
communication and behavioural disorders, epilepsy, and secondary
musculoskeletal disorders. In a recent systematic review from 2019, the
overall pooled prevalence of cerebral palsy per 1000 children surveyed is 2.95,
(95%CI 2.03–3.88). The pooled prevalence conducted in rural settings is 1.83
(95% CI 0.41–3.25). As children grow, they may
experience delays in reaching developmental milestones such as crawling,
walking, and speaking. ·
Exhibition
of abnormal movements
·
Involuntary
muscle contraction,
·
Jerky
movements, or athetosis,
·
Poor
coordination,
·
Balance
problems,
·
Difficulty
with fine motor skills such as writing, buttoning clothes
·
Seizures
·
Intellectual
disability
·
Vision Hearing impairments ·
mCIMT
(Modified Constraint Induced Movement Therapy) :
It has emerged as a main treatment approach for children with CP. As clinical
use of mCIMT in children continues to grow, additional studies are needed to
determine how basic parameters of the therapy affect outcomes. The application
of modified (less frequent and more prolonged) constraint programmes (mCIMT)
for young children seems more child friendly. - Bimanual Therapy: Bimanual therapy is a specialized rehabilitation approach designed to
improve the functional abilities of individuals, particularly children, with
cerebral palsy. Bimanual therapy focuses on enhancing the coordination and
integration of both hands simultaneously to promote independence and
participation in various tasks. Bimanual therapy typically involves a
combination of therapeutic activities and exercises tailored to the individual
needs and abilities of the child.
NEED OF STUDY: Cerebral palsy (CP) is a neurological,
non-progressive disorder that affects the central nervous system.
The motor disorders of cerebral palsy are often accompanied by disturbances of
sensation, perception, cognition, communication, and behavior and by secondary
musculoskeletal problem.
In
this study, an effort will be made to find out the effectiveness of the
Modified Constraint Induced Movement Therapy (mCIMT) and Bimanual Therapy in
improving upper limb motor function in children with hemiplegic CP.
Though
there is lack of evidence where both these therapies are compared. This is why
an effort will be made to find out the effectiveness of mCIMT in comparison
with Bimanual Therapy in improving the upper limb motor functions in children
with hemiplegic CP. OBJECTIVE
OF RESEARCH: 1.
To evaluate the
effectiveness of modified constraint induced movement therapy on improving the
upper limb functions in children with hemiplegic cerebral palsy. 2.
To evaluate the
effectiveness of bimanual therapy on improving the upper limb functions in
children with hemiplegic cerebral palsy.
To find out and compare the effectiveness of
mCIMT and Bimanual therapy on improving the upper limb functions in children
with hemiplegic cerebral palsy. RESEARCH HYPOTHESES
NULL
HYPOTHESES (Hο):
There
will be no significant difference between the effectiveness of modified
constraint induced movement therapy and bimanual therapy in improving the upper
limb functions in children with hemiplegic cerebral palsy.
ALTERNATIVE HYPOTHESES (H1):
There
will be a significant difference between the effectiveness of modified
constraint induced movement therapy and bimanual therapy in improving the upper
limb functions in children with hemiplegic cerebral palsy. Methodology: 30
children with hemiplegic cerebral palsy will be selected by convenient sampling.
They will be divided into two groups, group A and group B. Each group will have
15 children. Group A will receive modified constraint induced movement therapy (mCIMT)
and group B will receive bimanual therapy.A thorough assessment will be done
regarding hand function with MACS (Manual Ability Classification System) and
QUEST (Quality of Upper Extremity Skill Test) scale. After 10 weeks of
treatment the children will be assessed again with the given scales to find out
the parameters. Paired‘t’ test and independent‘t’ test will be done to find out
which of the intervention is more effective.
Expected
Outcome: It can be expected that, there will be some
improvement in both group after the given interventions. It is to be found out
if they are statistically significant or not, if yes, then which group is more
significant? And whether there will be any prominent difference between the two
interventions.
|