NCT05318677

Brief Summary

Spina bifida is one of the neural tube defects that cause neuromuscular dysfunction. Spina bifida is a disease accompanied by motor paralysis, musculoskeletal problems, Arnold-Chiari malformation, osteoporosis, hydrocephalus, upper limb coordination disorder. The affected upper extremity functionality and hand skills are very important for independence in daily living activities. There are some studies in the literature showing that upper extremity motor function is affected in patients with spina bifida. However, no study was found in which the upper extremity was investigated in terms of sensory and motor proficiency.The social and professional aspects of the upper extremity are of great importance.Therefore, our study aims to investigate the effects of upper extremity sensory and motor proficiency in patients with spina bifida

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

March 24, 2022

Last Update Submit

April 1, 2022

Conditions

Keywords

spina bifidaupper extremity functionsensemotor function

Outcome Measures

Primary Outcomes (2)

  • Sensory assesment of the children

    Sensory evaluation in the cases was made by evaluating the senses of stereognosis, graphesthesia, finger identification, and kinesthesia.

    May 2010

  • Motor proficiency of the children

    Motor proficiency of the children was assessed by Bruiniks Oseretsky test.

    May 2010

Study Arms (2)

1

Fifteen patients with spina bifida aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children. Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.

2

20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children. Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Fifteen patients with spina bifida and 20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study.

You may not qualify if:

  • Children who had a second illness and could not be contacted were not included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal DysraphismSensation DisordersMotor Disorders

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ozden Baskan

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 8, 2022

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share