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

NCT06460701 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/07104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Erb Palsy

Keywords

Erb's Palsy ,; mCIMT; Kinesiotaping; OBPI .

Outcome Measures

Primary Outcomes (2)

• Active Movement Scale

  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

  8 weeks

• Goniometer

  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).

  8 weeks

Study Arms (2)

Active comparator: modified constraint induced movement therapy without Kinesiotaping.

ACTIVE COMPARATOR

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

Other: m-CIMT without Kinesio taping

Experimental: modified constraint induced movement therapy along with kinesio taping.

EXPERIMENTAL

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

Other: m-CIMT along with kinesiotaping

Interventions

m-CIMT without Kinesio taping 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.

Active comparator: modified constraint induced movement therapy without Kinesiotaping.

m-CIMT along with kinesiotaping 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

Experimental: modified constraint induced movement therapy along with kinesio taping.

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children with visual deficits,
• Children with seizures or epilepsy,
• systemic disease or infectious disease,
• children with permanent arm deformities

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 36660395 BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Anna Zaheer, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will get separate treatment protocols and possible efforts will be put to mask both groups about the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 16, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)