- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06199167
The Effect of Action Observation Therapy on Upper Extremity Function in Children With Obstetric Brachial Plexus Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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İstanbul, Turkey, 34000
- Istanbul University Cerrahpasa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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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.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 weeks
|
|
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.
|
5 weeks
|
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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.
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5 weeks
|
|
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 weeks
|
|
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
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 weeks
|
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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.
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5 weeks
|
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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.
|
5 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MÇalışkan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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