NCT04132752

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 16, 2019

Last Update Submit

October 18, 2019

Conditions

Keywords

obstetric paralysishome exercisemotivationrehabilitationparents

Outcome Measures

Primary Outcomes (3)

  • 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.

    From baseline to 12th week

  • 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.

    From baseline to 12th week

  • 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.

    From baseline to 12th week

Secondary Outcomes (2)

  • Scoring elbow function

    From baseline to 12th week

  • Scoring hand function

    From baseline to 12th week

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Motivation

Control

NO INTERVENTION

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

Interventions

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

Intervention

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being classified as Narakas type 2a or 2b
  • Being aged between 0 - 18 months
  • Not having regular physiotherapy and rehabilitation program

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 12015722BACKGROUND
  • 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.

    PMID: 17275587BACKGROUND
  • 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.

    PMID: 26452749BACKGROUND
  • 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.

    PMID: 21631743BACKGROUND

MeSH Terms

Conditions

Paralysis, Obstetric

Interventions

Information Motivation Behavioral Skills Model

Condition Hierarchy (Ancestors)

Birth InjuriesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Intervention Hierarchy (Ancestors)

Models, PsychologicalModels, TheoreticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 21, 2019

Study Start

May 10, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share