- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460701
Effects of m-CIMT With and Without Kinesiotaping for Children With Erb's Palsy
Effects of Modified Constraint Induced Movement Therapy With and Without Kinesiotaping for Children With Erb's Palsy
The upper brachial plexus, a network of nerves in the neck and shoulder, is affected by Erb's palsy, often referred to as Erb-Duchenne palsy. This syndrome usually arises after labor, particularly if the baby's head and neck are pulled or stretched excessively during delivery. Erb's palsy can cause the hand and arm on the afflicted side of the body to become paralyzed or feeble. Erb's palsy symptoms can include: restricted range of motion in the injured arm. weakened hand and arm in the afflicted area, loss of feeling in the hand or arm. The effected arm is in "waiter's tip" position in which the elbow is bent and the wrist is flexed. The purpose of this research is to evaluate the effectiveness of modified constraint-induced movement therapy in children with erb's palsy, both with and without kinesiotaping.
Convenient sampling will be the method of sampling, and the study design will be randomized control trial. There will be two groups created with n = 40 subjects each. Twenty participants will be divided into two groups: twenty for each group will receive modified constraint-induced movement therapy plus kinesiotaping, while twenty for the other group will receive modified constraint-induced movement therapy alone. The youngsters will be evaluated using the Active Movement Scale.Both at the program's baseline and after the intervention is over, data will be gathered. The course of treatment will run for eight weeks straight, meeting three times a week for an hour each time. Based on inclusion criteria, subjects from Ayesha Amir Memorial Hospital and Children Hospital Faisalabad will be chosen. Data analysis will be done using SPSS 25.00.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Group A will be applied modified constraint induced movement therapy , session will last for one hour including following exercises such as ROM with the sling. Flexion, extension, abduction, and rotation of the shoulder. Flexion and extension of the elbow, Supination of forearm-Extension of wrist and finger. Stretching exercises for internal rotators , adductors ,extensors of shoulder. This will reduce the tightness and enhance the range of movement. Strengthening exercises also be applied to this group by throwing a ball in different directions above head position ,by drawing on paper stuck on the wall or window at different heights, by supinating bottles weighing <500g as tolerated by the child by thera band exercises above, across, and below the chest. Repetitive movement such as supinating the light bottles. Functional activities including some playful movement will be done by this group in which children are involved in different activities e.g playing with toys, blocks and such objects. Additionally, this group will engaged in a kinesiotaping program which aims to obtain more stability to the scapula on the affected side through facilitating middle and lower trapezius function. The shoulders will be kept in downward and back- ward position, while the alignment of scapulae should be manually maintained during the tape application. KT will set medially at the spinous processes (T2-T3 for middle trapezius and T12 for lower trapezius) and will be applied toward the acromion.
Group B will undergo same intervention such as group A alongwith m-CIMT but without the application of kinesiotaping.
There will be three sessions per week for the eight consecutive weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 2 years to 4 years.
- Children with Erb's palsy.
- Healthy BMI, ability to understand the command
- No previous mCIMT and kinesiotaping intervention was given
Exclusion Criteria:
- Children with visual deficits,
- Children with seizures or epilepsy,
- systemic disease or infectious disease,
- children with permanent arm deformities
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 |
|---|---|
|
Active Comparator: Active comparator: modified constraint induced movement therapy without Kinesiotaping.
in this group m-CIMT will be applied without kinesiotaping.
|
Baseline treatment m-CIMT will be applied includeing ROM with a sling, e.g shoulder flexion, extension, abduction, and rotation.
The elbow's flexion and extension, Forearm supination is the extension of the wrist and fingers.
Functional Training Using a tiny toy ball, practice tossing and catching it from various angles.
Play with modeling clay, constructing towers of the toy bricks using LEGOs,Using crayons, ripping a piece of paper towel,Grasping biscuits, Using a spoon, utilizing a glass to drink, comb hair, brush teeth,Using a bubble blower,With a toy in hand, putting cap, putting lotion.stretching to shoulder's extensors, adductor, and internal rotators ,wrist and elbow flexors.
strengthening exercises e.g a ball above head position in various directions,Using paper adhered to the window or wall at varying heights for drawing.
The session will go for one hour.
|
|
Experimental: Experimental: modified constraint induced movement therapy along with kinesio taping.
in this group m-CIMT will be applied along with kinesiotaping.
|
Modified constraint-induced movement therapy along with kinesiotaping will be applied. m-CIMT protocol is baseline treatment and it is is same as in the other group. This group also participated additionally in a kinesio taping program, which utilize KT with the goal of enhancing middle and lower trapezius function to increase stability in the scapula on the afflicted side. During the application of the tape, the shoulders were kept in a low and backward posture, and the scapular alignment was manually maintained. KT was administered at the acromion and positioned medially at the spinous processes (T2-T3 for the middle trapezius and T12 for the lower trapezius). For eight weeks in a row, there will be three sessions every week |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Movement Scale
Time Frame: 8 weeks
|
Active Movement Scale (AMS) is a unique assessment instrument that may be applied to children and newborns at any stage of development.. Tests are conducted for flexion, external rotation, internal rotation, abduction, and adduction of the shoulder, flexion and extension of the elbow, pronation and supination of the forearm, and flexion and extension of the wrist, finger, and thumb.
AMS is measured on an 8-point scale (0 for no discernible contraction and 7 for full motion).
For correct scoring, it is advised that the estimated passive range of motion (PROM) be confirmed using goniometry.
Using kappa statistics, the scores were examined for reliability and chance agreement was managed.
The 15 tested movements' overall kappa analysis revealed a moderate degree of score agreement (kappa = 0.51).
Eight of the fifteen movements examined fell into the highest strength of agreement group (kappa(quad) = 0.81-1.00),
according to quadratic-weighted kappa (kappa(quad)) statistics.
Two movements
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8 weeks
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Goniometer
Time Frame: 8 weeks
|
A goniometer is a specialized tool used in physical therapy that measures and evaluates the range of motion (ROM) of joints in the human body.
Physical therapists and other medical professionals use it as a vital tool for diagnosing, treating, and keeping track of a variety of musculoskeletal injuries, diseases, and rehabilitation processes.
The findings showed good intra-rater reliability between sessions (ICC2,1 = 0.83 to 0.98), across sessions (ICC2,2 = 0.79 to 0.97), and high inter-rater reliability between sessions (ICC2,2 = 0.79 to 0.92).
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Zaheer, MS, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/07104
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
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