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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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Paralyses focused on measuring obstetric paralysis, home exercise, motivation, rehabilitation, parents

Eligibility Criteria

undefined - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 16, 2019
    Last Updated
    October 18, 2019
    Sponsor
    Hacettepe University
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    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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