- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132752
Motivation's Effect on Home Exercise in Children With OBPP
October 18, 2019 updated by: Tüzün Fırat, Hacettepe University
Does Motivation of the Parents Affect the Efficiency of Home Exercises in Children With OBPP?
The present study examined the effect of motivation on home exercise program and children's functional scores.
33 OBPP children (Narakas Type 2) aged between 0-18 months were divided into two groups.
Intervention group was motivated via phone.
Both groups were informed about OBPP, performed home exercises and filled exercise diary.
Intrinsic Motivation Scale was used for measuring motivation and Gilbert and Raimondi Scoring and Active Movement Scoring were used for evaluating functional improvements at first assessment, 6th week and 12th week.
For final comparison, parents were divided into two more groups (highly motivated and motivated group) based on motivation scores.
Study Overview
Detailed Description
Home exercise program is widely used for treatment of OBPP children.
The present study examined the effect of motivation on home exercise program and children's functional scores.
33 OBPP children (Narakas Type 2) aged between 0-18 months were divided into two groups.
Intervention group was motivated via phone.
Both groups were informed about OBPP, performed home exercises and filled exercise diary.
Intrinsic Motivation Scale was used for measuring motivation and Gilbert and Raimondi Scoring and Active Movement Scoring were used for evaluating functional improvements at first assessment, 6th week and 12th week.
For final comparison, parents were divided into two more groups (highly motivated and motivated group) based on motivation scores.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
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
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being classified as Narakas type 2a or 2b
- Being aged between 0 - 18 months
- Not having regular physiotherapy and rehabilitation program
Exclusion Criteria:
- Having a clinical condition such as upper motor neuron lesion that may affect child's affected arm or whole body,
- Having secondary surgery for orthopedic problems within last 6 months.
- Mother having an unidentified cognitive problem,
- Parents having another child with a disability,
- Parents not willing to participate.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.
|
Families were called via phone weekly and all questions were answered.
Parents were motivated through phone.
|
No Intervention: Control
Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation change
Time Frame: From baseline to 12th week
|
Intrinsic motivation scale measurement: has 21 questions with likert scale rating 1 to 7. Lowest score 21; meaning not motivated at all, 84 means neutral and 147 means fully motivated.
|
From baseline to 12th week
|
Scoring general arm function
Time Frame: From baseline to 12th week
|
Active Movement Scale was used for scoring arm function: scale is scored from 1 to 5, with 1 being the worst and 5 being best functional status.
|
From baseline to 12th week
|
Scoring shoulder function
Time Frame: From baseline to 12th week
|
Gilbert and Raimondi's scale was used for scoring shoulder function: scale is scored from 1 to 5, with 1 being the worst and 5 being best functional status.
|
From baseline to 12th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scoring elbow function
Time Frame: From baseline to 12th week
|
Gilbert scale was used for scoring elbow function: scale is scored from 1 to 5, with 1 being the worst and 5 being best functional status.
|
From baseline to 12th week
|
Scoring hand function
Time Frame: From baseline to 12th week
|
Raimondi's scale was used for scoring hand function: scale is scored from 1 to 5, with 1 being the worst and 5 being best functional status.
|
From baseline to 12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Curtis C, Stephens D, Clarke HM, Andrews D. The active movement scale: an evaluative tool for infants with obstetrical brachial plexus palsy. J Hand Surg Am. 2002 May;27(3):470-8. doi: 10.1053/jhsu.2002.32965.
- James MA. Use of the Medical Research Council muscle strength grading system in the upper extremity. J Hand Surg Am. 2007 Feb;32(2):154-6. doi: 10.1016/j.jhsa.2006.11.008. No abstract available.
- Nijenhuis SM, Prange GB, Amirabdollahian F, Sale P, Infarinato F, Nasr N, Mountain G, Hermens HJ, Stienen AH, Buurke JH, Rietman JS. Feasibility study into self-administered training at home using an arm and hand device with motivational gaming environment in chronic stroke. J Neuroeng Rehabil. 2015 Oct 9;12:89. doi: 10.1186/s12984-015-0080-y.
- Bialocerkowski A, Kurlowicz K, Vladusic S, Grimmer K. Effectiveness of primary conservative management for infants with obstetric brachial plexus palsy. Int J Evid Based Healthc. 2005 Mar;3(2):27-44. doi: 10.1111/j.1479-6988.2005.00020.x.
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)
May 10, 2016
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
October 16, 2019
First Submitted That Met QC Criteria
October 17, 2019
First Posted (Actual)
October 21, 2019
Study Record Updates
Last Update Posted (Actual)
October 22, 2019
Last Update Submitted That Met QC Criteria
October 18, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HacettepeOBPPhome
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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