NCT06006988

Brief Summary

Stroke is a health problem that ranks second among the causes of death and third in the rate of severe disability . One of the most commonly reported problems after stroke is the structural and functional changes in the muscles . At the beginning of the structural changes of the muscles is the effect of the viscoelastic properties of the muscles. Various studies have reported an increase in skeletal muscle stiffness, which is dependent on elasticity as well as muscle viscosity after stroke . The initial condition of the affected trunk on both the ipsilateral and contralateral sides after stroke is defined as the earliest and most important factor in predicting functional recovery. Functional recovery after stroke was found to be associated with trunk control at a rate of 45-71% in general . We think that viscoelastic properties will change in trunk muscles of individuals with acute stroke and these changes may be related to trunk control disorder.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 1, 2023

Last Update Submit

August 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • trunk disorder scale

    It is a scale consisting of 17 parameters developed for the evaluation of trunk control in patients with neurological deficits (EK8). Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer.

    1 weeks

  • viscoelastic properties of muscle

    MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph. Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.

    1 weeks

Study Arms (1)

trunk disorder scale

EXPERIMENTAL

It is a 17-parameter scale developed for the evaluation of trunk control. Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance.

Combination Product: myoton pro

Interventions

myoton proCOMBINATION_PRODUCT

MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph.

trunk disorder scale

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ischemic cerebro-vascular disease within the first 72 hours,
  • Patients with a National Institute of Health (NIH) score below 15
  • No additional neurological and orthopedic problems
  • Patients who do not have any inconvenience in sitting hemodynamically
  • agree to participate in the study voluntarily

You may not qualify if:

  • Patients who come to the service outside the first 72 hours
  • Uncooperative patients
  • patients who have had two or more strokes
  • Those who have had a Trans Ischemic Attack (TIA)
  • Refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University

Gaziantep, 27500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 23, 2023

Study Start

August 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations