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CompletedNCT04132752Updated Oct 22, 2019

Motivation's Effect on Home Exercise in Children With OBPP

An interventional study of Motivation in Obstetric Paralyses, sponsored by Hacettepe University. Completed. Open to participants aged Up to 18 Months. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled May 2016, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
Up to 18 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstetric Paralyses

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Keywords

  • obstetric paralysis
  • home exercise
  • motivation
  • rehabilitation
  • parents
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 33 is close to the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Intervention

    Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.

    Other: Motivation

  • No intervention
    Control

    Parents were informed about obstetric brachial plexus palsy, given home exercise program and exercise diary.

Interventions

  • OtherMotivation

    Families were called via phone weekly and all questions were answered. Parents were motivated through phone.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline to 12th week

  2. 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.

    Time frame: From baseline to 12th week

  3. 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.

    Time frame: From baseline to 12th week

Secondary outcomes

  1. 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.

    Time frame: From baseline to 12th week

  2. 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.

    Time frame: From baseline to 12th week

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 12015722 ↗
  • 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. PubMed 17275587 ↗
  • 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. PubMed 26452749 ↗
  • 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. PubMed 21631743 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04132752
Lead sponsor
Hacettepe University
Responsible party
Tüzün Fırat (Assoc. Prof., Hacettepe University) — Principal investigator
First posted
Oct 21, 2019
Start date
May 10, 2016
Primary completion
May 1, 2018
Completion
May 1, 2018
Last update
Oct 22, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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