Effects of m-CIMT With and Without Kinesiotaping for Children With Erb's Palsy

NCT ID: NCT06460701

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-16

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Erb Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

it will be a randomized controlled trial in which non probability convenient sampling will be used. Two groups of 2-4 age will be formed in which participants will be randomly divided. Group A will receive m-CIMT along with kinesio taping while Group B will receive only m-CIMT.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
participants will get separate treatment protocols and possible efforts will be put to mask both groups about the treatment

Study Groups

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Active comparator: modified constraint induced movement therapy without Kinesiotaping.

in this group m-CIMT will be applied without kinesiotaping.

Group Type ACTIVE_COMPARATOR

m-CIMT without Kinesio taping

Intervention Type OTHER

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: modified constraint induced movement therapy along with kinesio taping.

in this group m-CIMT will be applied along with kinesiotaping.

Group Type EXPERIMENTAL

m-CIMT along with kinesiotaping

Intervention Type OTHER

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

Interventions

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m-CIMT without Kinesio taping

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.

Intervention Type OTHER

m-CIMT 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Zaheer, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah international university

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Kuran B, Azrak SD, Dogu B, Yilmaz F, Sirzai H, Oncu J, Terlemez R, Ayyildiz A. The Effect of the Modified Constraint-Induced Movement Therapy on the Upper Extremity Functions of Obstetric Brachial Plexus Palsy Patients. Sisli Etfal Hastan Tip Bul. 2022 Dec 19;56(4):525-535. doi: 10.14744/SEMB.2022.32956. eCollection 2022.

Reference Type BACKGROUND
PMID: 36660395 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/07104

Identifier Type: -

Identifier Source: org_study_id

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