NCT05021744

Brief Summary

Dysfunction due to weakness in respiratory muscles is one of the biggest problem that causes mortality and morbidity in neuromuscular diseases.Since the NMD have a crucial life-threading natural progression, many clinicians and researchers are trying to working out to increase life span and/or quality of life with medical and rehabilitative approaches.The relationship between upper extremity functions and respiratory functions in pediatric neuromuscular patients is still not clear. The clinician working with children with neuromuscular disease should be aware of the effects of muscle weakness and cognitive dysfunction on the respiratory system. Symptoms can be insidious and cause progressive loss of function, respiratory failure, and even death

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

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

December 13, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2015

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

August 4, 2021

Last Update Submit

September 27, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Respiratory Function Test

    Respiratory function tests are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange.RFT measurements were made with the patients in the sitting position, with the nostrils closed with the help of a soft-headed clip that would not cause discomfort. The patients were asked to inhale and then exhale with the help of a cap attached to the spirometer device, which was placed in the mouth and ensured that there was no air leakage. Measurements were carried out in accordance with the standardization criteria determined jointly by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Cosmed Pony FX brand respiratory function test device was used.The percentages of the predicted values (percent) for forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC and peak expiratory flow (PEF) were used for statistical analysis.

    1 day

  • Hand Grip Strength Test

    Jamar hand dynamometer, which was recommended by the American Society of Hand Therapists and which has high validity and reliability in many studies and therefore accepted as the gold standard, was used in the measurement of hand grip strength of children. Participants were instructed to sit in a straight-backed chair with feet placed flat on the floor, shoulder abduction and neutral rotation, elbow flexion at 90 °, forearm and wrist in neutral position. Participants were asked to make an isometric contraction by squeezing the dynamometer with as much force as possible, making sure that only one contraction is made for each measurement. In all measurements, the score is evaluated in kilograms.

    1 day

  • Hand Dexterity Assessment

    Nine hole peg test was used to measure hand dexterity. Patients were asked to take nine wooden stick, one by one, from container, place them into holes, then collect them from the holes and put them back in the container. The board should be positioned in the patient's midline. The hand that is not evaluated should hold the edge of the board and provide stability. Times to complete the test are recorded with stopwatch in seconds

    1 day

Secondary Outcomes (2)

  • Brooke Upper Extremity Functional Scale

    1 day

  • Vignos Functional Scale

    1 day

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Our study was carried out with 30 patients between the ages of 6-18 who were followed up with a diagnosis of neuromuscular disease.

You may qualify if:

  • to be diagnosed with NMD
  • to be in Stage 5 or below according to the Vignos scale (walking without assistance)
  • to be between Stage 1-4 according to the Brooke scale.

You may not qualify if:

  • Patients with severe systemic disease, ambulatory problem, cognitive problem, and upper extremity deformity were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Aysel Yıldız Ozer, Dr.

    Marmara University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 25, 2021

Study Start

December 13, 2014

Primary Completion

December 13, 2015

Study Completion

January 1, 2016

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share