Ultrasonograpy in Hemiplegic Patients

NCT06706063 | Active Not Recruiting

• 1 other identifier: SAUSG
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the architectural changes and muscle stiffness of the upper and lower extremity muscles in our hemiplegic patients ultrasonographically and to investigate their relationship with clinical assessment scales.

Conditions

Hemiplegia; Hemiparesis After Stroke; Spasticity

Outcome Measures

Primary Outcomes (4)

• Spasticity Evaluation

  Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In the MAS, patients are evaluated out of 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.

  T0 (First day), T1 (Second day)

• Fugl Meyer Assessment Questionnaire

  Fugl-Meyer Motor Assessment Scale was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom's motor recovery stages. Validity and reliability study was conducted in Turkish. The total score is between 0-66 and higher scores indicates better motor functions.

  T0 (First day), T1 (Second day)

• Neurophysiological Evaluation

  Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.

  T0 (First day), T1 (Second day)

• Ultrasonographic Evaluation

  The biceps brachii, flexor digitorum superficialis and profundus muscles and gastrocnemius muscles of the participants on the affected and unaffected sides will be evaluated ultrasonographically. Two researchers (with at least 5 years of experience in ultrasound imaging) blinded to the clinical evaluations of the patients and previous measurements will evaluate the same patients at two different times to test interobserver reproducibility. Muscle thickness, fascicle length and pennation angle will be recorded in B-mode imaging. In addition, elastographic evaluation will be performed on the same muscles.

  T0 (First day), T1 (Second day)

Secondary Outcomes (1)

• Functional Independence Measurement (FIM)

  T0 (First day), T1 (Second day)

Interventions

Ultrasonography of muscles OTHER

The biceps brachii, flexor digitorum superficialis and profundus muscles and gastrocnemius muscles of the participants on the affected and unaffected sides will be evaluated ultrasonographically. Two researchers (with at least 5 years of experience in ultrasound imaging) blinded to the clinical evaluations of the patients and previous measurements will evaluate the same patients at two different times to test interobserver reproducibility. Muscle thickness, fascicle length and pennation angle will be recorded on B-mode imaging. In addition, elastographic evaluation will be performed on the same muscles and strain rate will be recorded.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 hemiplegic patients aged between 40-70 years, with unilateral hemiplegia, and at least 3 months after a cerebrovascular accident, who applied to the AFSU Department of Physical Medicine and Rehabilitation will be included.

You may qualify if:

• Age 40-70
• Unilateral hemiplegia
• At least 3 months since cerebrovascular accident

You may not qualify if:

• Operation or fracture in the last 3 months
• Botulinum toxin injection in the last 6 months

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University Health Application and Research Center Physical Medicine and Rehabilitation Clinic

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: April 15, 2022
• Primary Completion: May 15, 2025
• Study Completion: June 15, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)