Brachial Plexus PalsyNCT04193072
Imagery Ability in Obstetric Brachial Plexus Palsy
An observational study of Brachial Plexus Palsy and Image, Body, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Obstetric brachial plexus palsy (OBPP) is the paralysis of the ipsilateral upper extremity after a brachial plexus injury that occurs during labor. Imagery is to rehearse sensorial experiences in the mind such as auditory, visual, tactile, olfactory, gustatory or kinesthetic sensation. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Palsy, Image, Body
- What is being tested?
- Assessment of imagery ability
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2017to 25 Mar 2018
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with obstetric brachial plexus palsy and healthy children.
Who may be able to join
- Ages between 8-18 years
- Children with OBPP Narakas's classification system rating of Type 1, Type 2a, Type 2b, or Type 3
- Standardized mini-mental state examination score >24
- With no physical or neurological condition affecting motor development
Who cannot join
- Narakas's classification system rating of Type 4
- Standardized mini-mental state examination score <24
- Surgical operation in last 6 months
- Physical or neurological conditions
- Refuse to attend to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Imagery Ability in Children With Obstetric Brachial Plexus Palsy
Obstetric brachial plexus palsy (OBPP) is the paralysis of the ipsilateral upper extremity after a brachial plexus injury that occurs during labor. Imagery is to rehearse sensorial experiences in the mind such as auditory, visual, tactile, olfactory, gustatory or kinesthetic sensation. Imagery is used as a new technique in rehabilitation recently. Various studies have reported the importance of imagery and using imagery as a rehabilitation technique in different neurologic and orthopedic conditions. This study aimed to evaluate imagery ability in children with OBPP.
- Conditions
- Brachial Plexus Palsy, Image, Body
- Being tested
- Assessment of imagery ability
- Keywords
- brachial plexus, imagery, body image, sensation, questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of imagery abilityBehavioural
Movement imagery, kinesthetic imagery, and visual imagery ability assessed.
| Study group | Role | What they receive |
|---|---|---|
| Obstetric brachial plexus palsy | Not described Receives: Behavioral: Assessment of imagery ability | |
| Healthy | Not described Receives: Behavioral: Assessment of imagery ability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Imagery Questionnaire-3
Movement Imagery Questionnaire-3 is a 12-item questionnaire to assess an individual's ability to achieve specific four movements using internal visual imagery, external visual imagery, and kinesthetic imagery.
Measured: 2 weeks
Kinesthetic and Visual Imagery Questionnaire-20
Kinesthetic and Visual Imagery Questionnaire-20 assess an individual's ability to visualize and feel imagined movements.
Measured: 2 weeks
Active Movement Scale
Active Movement Scale evaluates 15 joint movements in the upper extremity against gravity and gravity-eliminated positions. Each movement is given a score between 0-7: 0 means no contraction, 7 means full range of motion.
Measured: 1 week
Narakas's Sensory Grading System
Narakas's Sensory Grading System evaluates the response to painful stimuli in the upper extremity with 0-3-point scale: 0 indicates no reaction, 3 indicates a normal reaction.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start2 Oct 2017
- Primary completion27 Jan 2018
- Study completion25 Mar 2018
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursena Şengün, Istanbul Medipol University Hospital
- Investigators
- Nursena Şengün, PT, MSc, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193072
- Sponsor's protocol ID
- 10840098-604.01.01-E.10507
- Status last verified
- Sep 2023
- First submitted
- 6 Dec 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Imagery Ability in Children With Obstetric Brachial Plexus Palsy
- ClinicalTrials.gov ID
- NCT04193072
- Acronym / sponsor ID
- 10840098-604.01.01-E.10507
- Conditions
- Brachial Plexus Palsy, Image, Body
- Keywords
- brachial plexus, imagery, body image, sensation, questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 27 Jan 2018 (actual)
- Study completion
- 25 Mar 2018 (actual)
- First posted
- 10 Dec 2019 (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.
Obstetric brachial plexus palsy (OBPP) is the paralysis of the ipsilateral upper extremity after a brachial plexus injury that occurs during labor. Imagery is to rehearse sensorial experiences in the mind such as auditory, visual, tactile, olfactory, gustatory or kinesthetic sensation. Imagery is used as a new technique in rehabilitation recently. Various studies have reported the importance of imagery and using imagery as a rehabilitation technique in different neurologic and orthopedic conditions. This study aimed to evaluate imagery ability in children with OBPP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstetric brachial plexus palsy | – | Behavioral: Assessment of imagery ability |
| Healthy | – | Behavioral: Assessment of imagery ability |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with obstetric brachial plexus palsy and healthy children.
Key inclusion criteria (4 listed)
- Ages between 8-18 years
- Children with OBPP Narakas's classification system rating of Type 1, Type 2a, Type 2b, or Type 3
- Standardized mini-mental state examination score >24
- With no physical or neurological condition affecting motor development
Key exclusion criteria (5 listed)
- Narakas's classification system rating of Type 4
- Standardized mini-mental state examination score <24
- Surgical operation in last 6 months
- Physical or neurological conditions
- Refuse to attend to the study
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 |
|---|---|---|
| Assessment of imagery abilityMovement imagery, kinesthetic imagery, and visual imagery ability assessed. | Behavioural | Healthy, Obstetric brachial plexus palsy |
Primary outcome
Movement Imagery Questionnaire-3
Time frame: 2 weeks
Movement Imagery Questionnaire-3 is a 12-item questionnaire to assess an individual's ability to achieve specific four movements using internal visual imagery, external visual imagery, and kinesthetic imagery.
Kinesthetic and Visual Imagery Questionnaire-20
Time frame: 2 weeks
Kinesthetic and Visual Imagery Questionnaire-20 assess an individual's ability to visualize and feel imagined movements.
Active Movement Scale
Time frame: 1 week
Active Movement Scale evaluates 15 joint movements in the upper extremity against gravity and gravity-eliminated positions. Each movement is given a score between 0-7: 0 means no contraction, 7 means full range of motion.
Narakas's Sensory Grading System
Time frame: 1 week
Narakas's Sensory Grading System evaluates the response to painful stimuli in the upper extremity with 0-3-point scale: 0 indicates no reaction, 3 indicates a normal reaction.
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 29 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries
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Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
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Enrolling by invitation
Virtual Reality and Dual-Task Training for Cortical Plasticity in Children With Brachial Plexus Injury
Brachial Plexus Birth Palsy, Physical Therapy
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.
Nursena Şengün, PT, MSc principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Palsy and Image, Body, run by Istanbul Medipol University Hospital 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 29 Sep 2023. 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?
Movement Imagery Questionnaire-3 (time frame: 2 weeks). The study lists 4 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 29 Sep 2023.