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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06199167
Other study ID # MÇaliskan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2023
Est. completion date December 20, 2023

Study information

Verified date January 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Musculoskeletal problems in the upper limb (UL) caused by nerve damage following Obstetric Brachial Plexus Injury (OBPI) and disorders affecting the use of the UL can limit activities of daily living (ADLs) and limit the child's participation in school and society. Method: Twenty-six children with OBPY aged between 6-17 years participated in the study and were randomised AOT and Photo Observation (PO) groups in equal numbers by stratified randomisation. In the 15-session treatment, a total of 18 ADL activities related to personal care, dressing, eating and preparation, transfer and mobilisation activities, reaching, and sports activities were studied with six exercises per session. The AOT group watched each ADL activity for two minutes through pre-prepared videos and then repeated the movement they watched for three minutes. The PO group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes. The same sequence was continued for six exercises and one session was completed in approximately 30 minutes. Abilhand-Kids (AK), Seated Medicine Ball Throw (SMBT), Modified Push-up Test (MPT), Functional Reach Test (FRT), Lateral Reach Test (LRT), Brachial Plexus Outcome Measurement (BPOM), Gilbert and Raimondi Score (GRS), Box Block Test (BBT) were performed before and after the treatment.


Description:

Introduction: Musculoskeletal problems in the upper limb (UL) caused by nerve damage following Obstetric Brachial Plexus Injury (OBPI) and disorders affecting the use of the UL can limit activities of daily living (ADLs) and limit the child's participation in school and society. No study investigating the effect of EGT in children with OBPY has been found in the literature. Based on this deficiency, we aimed to investigate the effect of EGT in children with OBPY in a randomised controlled study. Hypotheses of our study H0: There is no difference between Action Observation Therapy and Photo Observation in improving upper extremity functional skills in children with OBPY. H1: There is a difference between Action Observation Therapy and Photo Observation in improving upper extremity functional skills in children with OBPY. Method: Twenty-six children with OBPY aged between 6-17 years participated in the study and were randomised AOT and Photo Observation (PO) groups in equal numbers by stratified randomisation. In the 15-session treatment, a total of 18 ADL activities related to personal care, dressing, eating and preparation, transfer and mobilisation activities, reaching, and sports activities were studied with six exercises per session. The AOT group watched each ADL activity for two minutes through pre-prepared videos and then repeated the movement they watched for three minutes. The PO group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes. The same sequence was continued for six exercises and one session was completed in approximately 30 minutes. Abilhand-Kids (AK), Seated Medicine Ball Throw (SMBT), Modified Push-up Test (MPT), Functional Reach Test (FRT), Lateral Reach Test (LRT), Brachial Plexus Outcome Measurement (BPOM), Gilbert and Raimondi Score (GRS), Box Block Test (BBT) were performed before and after the treatment.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 20, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Being between the ages of 6-18 - OBPY diagnosed in Type 1, Type 2a, Type 2b group according to Narakas classification system - Triceps brachii muscle strength above 3/5 in manual muscle strength assessment - Family and child agree to take part in the study Exclusion Criteria: - History of upper extremity surgery and Botox in the last 6 months - Difficulty in understanding the commands given - Visual and hearing problems - Finding of shoulder dislocation - Orthopaedic problems associated with OBPY

Study Design


Intervention

Behavioral:
Action Observation Therapy
The Action Observation Therapy group watched each ADL activity for two minutes through pre-prepared videos and then repeated the movement they watched for three minutes. In the 15-session treatment, a total of 18 ADL activities.
Photo Observation
The Photo Observation group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes. In the 15-session treatment, a total of 18 ADL activities.

Locations

Country Name City State
Turkey Istanbul University Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abilhand Kids ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved 5 weeks
Primary Seated Medicine Ball Throw This test measures upper body (arm) strength and explosive power. By keeping the back in contact with the wall the strength of the arms only are tested. 5 weeks
Primary Modified Push-up Test The Modified Push-Up Test is used to measure upper body strength endurance and trunk stability. This variation, which uses a modified technique with a clap behind the back while in the 'down' position and a touch from one hand to the other in the 'up' position. 5 weeks
Primary Functional Reach Test Functional Reach Test (FRT) is the maximal distance one can reach forward beyond arm's length while maintaining a fixed standing position. 5 weeks
Primary Lateral Reach Test The LR Test measures postural stability in the medial-lateral direction by assessing the maximum distance an individual can reach laterally beyond arm's length at shoulder height, while maintaining a fixed base of support in the standing position 5 weeks
Secondary Brachial Plexus Outcome Measurement The Brachial Plexus Outcome Measure (BPOM) scale was developed in 2012 by Emily S. Ho and contains 14 items that measure activity and self-evaluation. 5 weeks
Secondary Gilbert and Raimondi Score The Gilbert and Raimondi Assessment System is an assessment system developed by Gilbert to assess shoulder and elbow function and Raimondi to assess hand function. 5 weeks
Secondary Box Block Test The Box and Block Test (BBT) measures unilateral gross manual dexterity. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. 5 weeks
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