Clinical trial NCT06460701: Effects of m-CIMT With and Without Kinesiotaping for Children With Erb's Palsy
Official title: Effects of Modified Constraint Induced Movement Therapy With and Without Kinesiotaping for Children With Erb's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erb Palsy
Keywords: Erb's Palsy ,
mCIMT
Kinesiotaping
OBPI .
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Active Movement Scale
timeFrame: 8 weeks
measure: Goniometer
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah International University
name: Anna Zaheer, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.