Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04132752
Other study ID # HacettepeOBPPhome
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2016
Est. completion date May 1, 2018

Study information

Verified date October 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. From baseline to 12th week
Secondary 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. From baseline to 12th week