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Neuromuscular DiseasesNCT05021744

Do Handgrip Strength and Dexterity Predict of Respiratory Function ?

An observational study of Neuromuscular Diseases, run by Bezmialem Vakif University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Neuromuscular Diseases
How many people
30 participants
Where
No sites listed yet
Study dates
13 Dec 2014to 1 Jan 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: Do Hand Grip Strength and Dexterity Predict of Respiratory Function in Neuromuscular Disease ?

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

Read the detailed description

Background:Neuromuscular diseases are acquired or hereditary diseases that affect the function of the muscles in our body caused by the nerves not sending information to your muscles and/or problems with the muscles not working properly.

Objective:The aim of our study is to discover more cost-effective and practical tools to predict respiratory function losses that may be a significant problem in children with neuromuscular disease.

Methods: Hand grip strength and dexterity of children with neuromuscular disease were measured using the dynamometer and the nine-hole-peg-test respectively. The Vignos and Brooke Upper Extremity Functional Scales were used to evaluate functional status for patient recruitment.Respiratory function parameters:forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak expiratory flow(PEF) were evaluated with spirometry.

Medical subject headings
Neuromuscular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day

  2. 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.

    Measured: 1 day

  3. 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

    Measured: 1 day

Secondary outcomes (2)

  1. Brooke Upper Extremity Functional Scale

    The Brooke Upper Extremity Scale is a 6-point scale that allows classification of upper extremity function and also helps document progression.

    Functional Grades: Arms and Shoulders:

    Standing with arms at the sides, the patient can abduct the arms in a full circle until they touch above the head.

    The patient can raise the arms above the head only by flexing the elbow or by using accessory muscles (i.e. by shortening the circumference of the movement) The patient cannot raise hands above the head, but can raise an 8-oz. glass of water to the mouth (using both hands if necessary).

    The patient can raise hands to mouth, but cannot raise 8 oz. glass of water to the mouth The patient cannot raise hands to the mouth, but can use the hands to hold a pen or to pick up pennies from a table.

    The patient cannot raise hands to the mouth and has no useful function of the hands.

    Measured: 1 day

  2. Vignos Functional Scale

    In order to determine the patients to be included in the study, the ambulation levels of the patients were evaluated with the Vignos scale.

    Vignos scale for lower extremities

    1. Walks and climbs stairs without assistance
    2. Walks and climbs stair with aid of railing
    3. Walks and climbs stairs slowly with aid of railing (over 25 seconds for 8 standard steps)
    4. Walks unassisted and rises from chair but cannot climb stairs
    5. Walks unassisted but cannot rise from chair or climb stairs
    6. Walks only with assistance or walks independently with long leg braces
    7. Walks in long leg braces but requires assistance for balance
    8. Stands in long leg braces but unable to walk even with assistance
    9. Is in a wheelchair
    10. Is confined to a bed

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start13 Dec 2014
  3. Primary completion13 Dec 2015
  4. Study completion1 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05021744
Sponsor's protocol ID
BezmialemVU270717
Status last verified
Sep 2021
First submitted
4 Aug 2021
Last updated
1 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neuromuscular Diseases, run by Bezmialem Vakif University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Function Test (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05021744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.

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