- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04193072
Imagery Ability in Obstetric Brachial Plexus Palsy
September 27, 2023 updated by: Nursena Şengün, Istanbul Medipol University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul Medipol University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Children with obstetric brachial plexus palsy and healthy children.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy
|
Movement imagery, kinesthetic imagery, and visual imagery ability assessed.
|
Obstetric brachial plexus palsy
|
Movement imagery, kinesthetic imagery, and visual imagery ability assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 weeks
|
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.
|
2 weeks
|
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.
|
1 week
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nursena Şengün, PT, MSc, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2017
Primary Completion (Actual)
January 27, 2018
Study Completion (Actual)
March 25, 2018
Study Registration Dates
First Submitted
December 6, 2019
First Submitted That Met QC Criteria
December 6, 2019
First Posted (Actual)
December 10, 2019
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.10507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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