- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07673289
Comparative Effect of CIMT and PNFTechnique on Hands Dexterity in Cerebral Palsy
Comparative Effect of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation Technique on Hands Dexterity in Cerebral Palsy
Cerebral Palsy (CP) is a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The primary motor impairments in CP often include issues with muscle tone, reflexes, and coordination. Among the various motor disorders associated with CP, impairment of the upper extremities is particularly common and functionally debilitating. Specifically, reduced hand dexterity the ability to perform coordinated, fine motor tasks significantly impacts a child's independence in daily activities such as feeding, dressing, and school-related tasks like writing. Therefore, improving hand function is a critical goal in physiotherapy for this population The objective of this study was to compare the effectiveness of a constraint induced movement therapy ( CIMT ) and Proprioceptive neuromuscular facilitation technique on dexterous movement of hands in cerebral palsy .The study design will be Randomized Controlled Trail. The study setting will be Pediatric Rehabilitation Center or Physiotherapy Department. The duration of study will be 10 months after approval of synopsis. The sample size will be 20 which is calculated by epitools. The sampling technique will be Non-probability convenient sampling . Children who are diagnosed with cerebral palsy will be included. Children with other musculoskeletal and neurological issues will be excluded. Data Collection Tools will be Box and Block test and Pediatric Evaluation of Disability Inventory.. The data will be analyzed using SPSS 23.
Keyword Cerebral Palsy, Constraint induced movement therapy (CIMT), dexterous movement, Proprioceptive neuromuscular facilitation
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Danish Hassan
- Phone Number: +923457946009
- Email: danish.hassan@riphah.edu.pk
Study Locations
-
-
Punjab Province
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Lalian, Punjab Province, Pakistan
- Recruiting
- Baloch Hospital
-
Contact:
- Dr. Riaz Baloch, MBBS
- Phone Number: 03008707404
- Email: riazbaloch099@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 8 to 13 years of age
- Both male and female
- Children with moderate level of mental retardation who are able to follow commands
Exclusion Criteria:
- Children with other musculoskeletal and neurological issues.
- Children who have complications such as epilepsy, congenital heart condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Constraint-Induced Movement Therapy Group
participants underwent Constraint-Induced Movement Therapy (CIMT) alongside conventional physical therapy, conducted five days a week for two hours daily (excluding weekends).
This therapy encouraged the active use of the affected upper limb while immobilizing the unaffected limb with a mitt or sling.
The aim was to improve motor recovery by combating "learned non-use."
Participants engaged in repetitive, task-oriented activities tailored to their skills, such as reaching, grabbing, lifting, and handling objects of various weights and sizes.
Fine motor skills exercises, like buttoning, writing, and stacking blocks, were included, progressively increasing in difficulty to enhance the application of these skills in daily activities.Therapists observed participants, provided feedback, and ensured the correct execution of movements, utilizing intense practice and molding techniques.
|
In Group A, participants underwent Constraint-Induced Movement Therapy (CIMT) alongside conventional physical therapy, conducted five days a week for two hours daily (excluding weekends).
This therapy encouraged the active use of the affected upper limb while immobilizing the unaffected limb with a mitt or sling.
The aim was to improve motor recovery by combating "learned non-use."
Participants engaged in repetitive, task-oriented activities tailored to their skills, such as reaching, grabbing, lifting, and handling objects of various weights and sizes.
Fine motor skills exercises, like buttoning, writing, and stacking blocks, were included, progressively increasing in difficulty to enhance the application of these skills in daily activities.Therapists observed participants, provided feedback, and ensured the correct execution of movements, utilizing intense practice and molding techniques.
|
|
Experimental: Proprioceptive Neuromuscular Facilitation Therapy Group
Group B received Proprioceptive Neuromuscular Facilitation (PNF) therapy, each session lasting 1.5 hours per day.
The PNF approach aimed to enhance functional motor abilities,reduce stiffness, and activate neuromuscular responses.
Treatment included diagonal and spiral movement patterns involving the wrist, elbow, and shoulder joints, adhering to a "stretch, contract, and relax" protocol.
This protocol involved passively stretching the limb, followed by isometric contractions lasting 10 seconds.
Repeated stretching of hypertonic muscles and isotonic or eccentric movements helped alleviate spasticity and improve flexibility.
Therapists provided verbal and tactile cues to guide correct movements and enhance muscular coordination.
Assessments of spasticity and functional motor abilities were conducted after given time of intervention
|
Group B received Proprioceptive Neuromuscular Facilitation (PNF) therapy, each session lasting 1.5 hours per day.
The PNF approach aimed to enhance functional motor abilities,reduce stiffness, and activate neuromuscular responses.
Treatment included diagonal and spiral movement patterns involving the wrist, elbow, and shoulder joints, adhering to a "stretch, contract, and relax" protocol.
This protocol involved passively stretching the limb, followed by isometric contractions lasting 10 seconds.
Repeated stretching of hypertonic muscles and isotonic or eccentric movements helped alleviate spasticity and improve flexibility.
Therapists provided verbal and tactile cues to guide correct movements and enhance muscular coordination.
Assessments of spasticity and functional motor abilities were conducted after given time of intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block test
Time Frame: 6 weeks
|
This test is used to measure manual dexterity.
This test is simple, cheap and quick.
The test can be used for different populations to assess the coordinated movements of the hands.
The test-retest reliability on more weak hand is 0.98 and the less weak hand is 0.93.
It has good convergent validity as the value is 0.80
|
6 weeks
|
|
Action Research Arm Test
Time Frame: 6 weeks
|
The Action Research Arm Test (ARAT) was used, assessing grasp, grip, pinch, and general movement with a score range of 0-57, where higher scores indicated improved motor function.
The ARAT demonstrated high test-retest reliability (r = 0.98).
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Riaz Baloch, MBBS, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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