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Completed

NCT Number: NCT06199167

The Effect of Action Observation Therapy on Upper Extremity Function in Children With Obstetric Brachial Plexus Injury

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.

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Key information

Conditions

Brachial Plexus Palsy Obstetric; Injury Wounds and Injuries

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Action observation therapy

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Abilhand Kids

    Time frame: 5 weeks

    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

  2. Seated Medicine Ball Throw

    Time frame: 5 weeks

    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.

  3. Modified Push-up Test

    Time frame: 5 weeks

    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.

  4. Functional Reach Test

    Time frame: 5 weeks

    Functional Reach Test (FRT) is the maximal distance one can reach forward beyond arm's length while maintaining a fixed standing position.

  5. Lateral Reach Test

    Time frame: 5 weeks

    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

Secondary outcomes

  1. Brachial Plexus Outcome Measurement

    Time frame: 5 weeks

    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.

  2. Gilbert and Raimondi Score

    Time frame: 5 weeks

    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.

  3. Box Block Test

    Time frame: 5 weeks

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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