NCT04193072

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

December 6, 2019

Last Update Submit

September 27, 2023

Conditions

Keywords

brachial plexusimagerybody imagesensationquestionnaires

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    1 week

Study Arms (2)

Obstetric brachial plexus palsy

Behavioral: Assessment of imagery ability

Healthy

Behavioral: Assessment of imagery ability

Interventions

Movement imagery, kinesthetic imagery, and visual imagery ability assessed.

HealthyObstetric brachial plexus palsy

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with obstetric brachial plexus palsy and healthy children.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Nursena Şengün, PT, MSc

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 10, 2019

Study Start

October 2, 2017

Primary Completion

January 27, 2018

Study Completion

March 25, 2018

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations