Motivation's Effect on Home Exercise in Children With OBPP
Primary Purpose
Obstetric Paralyses
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivation
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Paralyses focused on measuring obstetric paralysis, home exercise, motivation, rehabilitation, parents
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.
Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.
Outcomes
Primary Outcome Measures
Motivation change
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.
Scoring general arm function
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.
Scoring shoulder function
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.
Secondary Outcome Measures
Scoring elbow function
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.
Scoring hand function
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.
Full Information
NCT ID
NCT04132752
First Posted
October 16, 2019
Last Updated
October 18, 2019
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT04132752
Brief Title
Motivation's Effect on Home Exercise in Children With OBPP
Official Title
Does Motivation of the Parents Affect the Efficiency of Home Exercises in Children With OBPP?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2016 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Paralyses
Keywords
obstetric paralysis, home exercise, motivation, rehabilitation, parents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
33 children with obstetric brachial plexus palsy (OBPP) were randomized into control or intervention groups. Both groups parents were informed about OBPP, given home exercise and exercise diary. Intervention group was called via phone weekly in order to motivate and answer questions. Children's functional scores and parents motivation was measured.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.
Intervention Type
Other
Intervention Name(s)
Motivation
Intervention Description
Families were called via phone weekly and all questions were answered. Parents were motivated through phone.
Primary Outcome Measure Information:
Title
Motivation change
Description
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.
Time Frame
From baseline to 12th week
Title
Scoring general arm function
Description
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.
Time Frame
From baseline to 12th week
Title
Scoring shoulder function
Description
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.
Time Frame
From baseline to 12th week
Secondary Outcome Measure Information:
Title
Scoring elbow function
Description
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.
Time Frame
From baseline to 12th week
Title
Scoring hand function
Description
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.
Time Frame
From baseline to 12th week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12015722
Citation
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.
Results Reference
background
PubMed Identifier
17275587
Citation
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.
Results Reference
background
PubMed Identifier
26452749
Citation
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.
Results Reference
background
PubMed Identifier
21631743
Citation
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.
Results Reference
background
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Motivation's Effect on Home Exercise in Children With OBPP
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