Brachial Plexus PalsyNCT06199167
The Effect of Action Observation Therapy on Upper Extremity Function in Children With Obstetric Brachial Plexus Injury
A study testing Action Observation Therapy and Photo Observation in people with Brachial Plexus Palsy and Obstetric; Injury, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Brachial Plexus Palsy, Obstetric; Injury
- What is being tested?
- Action Observation Therapy and Photo Observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, 34000
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. 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.
Read the 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.
- Conditions
- Brachial Plexus Palsy, Obstetric; Injury
- Being tested
- Action Observation Therapy, Photo Observation
- Keywords
- Obstetric Brachial Plexus Injury, Action Observation Therapy, Upper Limb Function, Visual Motor Imagination
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TherapyBehavioural
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 ObservationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Action Observation Therapy | Experimental | 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. Receives: Behavioral: Action Observation Therapy |
| Photo Observation | Experimental | The Photo Observation group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes. Receives: Behavioral: Photo Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 5 weeks
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
Measured: 5 weeks
Secondary outcomes (3)
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.
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start12 May 2023
- Primary completion30 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Çalışkan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199167
- Sponsor's protocol ID
- MÇalışkan
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Action Observation Therapy on Upper Extremity Function in Children With Obstetric Brachial Plexus Injury
- ClinicalTrials.gov ID
- NCT06199167
- Acronym / sponsor ID
- MÇalışkan
- Conditions
- Brachial Plexus Palsy, Obstetric; Injury
- Keywords
- Obstetric Brachial Plexus Injury, Action Observation Therapy, Upper Limb Function, Visual Motor Imagination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Observation Therapy | Experimental | Behavioral: Action Observation TherapyThe 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. |
| Photo Observation | Experimental | Behavioral: Photo ObservationThe Photo Observation group observed the photographs taken from the video for two minutes and then practised the movement described for three minutes. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TherapyThe 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. | Behavioural | Action Observation Therapy |
| Photo ObservationThe 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. | Behavioural | Photo Observation |
Primary outcome
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
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.
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.
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.
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
3 secondary outcomes
Brachial Plexus Outcome Measurement
Time frame: 5 weeks
Gilbert and Raimondi Score
Time frame: 5 weeks
Box Block Test
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy and Photo Observation in people with Brachial Plexus Palsy and Obstetric; Injury, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abilhand Kids (time frame: 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.