Skip to main content
OpenTrials
Completed

NCT Number: NCT07083752

Investigation of the Effects of Upper Extremity Botulinum Toxin Application on Forearm Muscle Thickness and Motor Recovery in Patients With Hemiplegia

In this study, we aimed to examine the effects of the botulinum toxin (BoNT) application on muscle thickness and motor recovery in stroke patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

About this study

Stroke is the second leading cause of death worldwide. It poses a major risk for disability. Its prevalence is high in developing countries. Spasticity is among the complications of stroke. Excessive spasticity can cause impairments and limitations in patients' motor activity and participation in daily life. Botulinum toxin (BoNT) injection is one of the preferred treatment options. Studies on botulinum toxin administration in stroke patients generally focus on treatment efficacy and motor recovery. Studies examining the effects of botulinum toxin administration on both muscle thickness and motor recovery are few in number. In this study, we aimed to examine the effects of the botulinum toxin (BoNT) application on upper extremity muscle thickness and motor recovery in stroke patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be between the ages of 30-75.
  • Patients who received botulinum toxin injection to their upper extremities at least 3 months after a cerebrovascular accident.
  • Patients must have had cerebrovascular disease for the first time.

Exclusion criteria

  • Presence of a preexisting musculoskeletal deformity in the upper extremity where botulinum toxin was administered
  • Patients with spinal cord injury, multiple sclerosis, and cerebral palsy
  • Presence of malignancy.

Treatment and study plan

Botulinum toxin application

Drug

Hemiplegic stroke patients who received upper extremity botulinum toxin will be evaluated retrospectively. Information regarding upper extremity motor recovery, spasticity levels, and muscle thickness measured by ultrasound before and one month after botulinum toxin administration will be obtained from file records.

Primary outcomes

  1. Muscle Thickness

    Time frame: Before treatment

    Muscle thickness measurements were performed using a Falcon 2101 EXL 2003 ultrasound device equipped with an 8 MHz linear probe, both before and one month after botulinum toxin application.

    In patients who received botulinum toxin injections into the m. brachialis, m. pronator teres, m. flexor carpi radialis, m. flexor carpi ulnaris, m. flexor digitorum profundus, and m. flexor digitorum superficialis, muscle thickness was measured using ultrasound from the proximal one-third of the volar side of the forearm. Measurements were taken before and one month after the application. Muscle thickness was recorded by measuring the vertical distance between the subcutaneous tissue and the radius and ulna bone borders on the ultrasound image.

  2. Muscle Thickness

    Time frame: 4 week after treatment

    Muscle thickness measurements were performed using a Falcon 2101 EXL 2003 ultrasound device equipped with an 8 MHz linear probe, both before and one month after botulinum toxin application.

    In patients who received botulinum toxin injections into the m. brachialis, m. pronator teres, m. flexor carpi radialis, m. flexor carpi ulnaris, m. flexor digitorum profundus, and m. flexor digitorum superficialis, muscle thickness was measured using ultrasound from the proximal one-third of the volar side of the forearm. Measurements were taken before and one month after the application. Muscle thickness was recorded by measuring the vertical distance between the subcutaneous tissue and the radius and ulna bone borders on the ultrasound image.

  3. Brunnstrom Motor Recovery Stages

    Time frame: Before treatment

    Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.

  4. Brunnstrom Motor Recovery Stages

    Time frame: 4 week after treatment

    Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: Before treatment

    Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.

  2. Modified Ashworth Scale

    Time frame: 4 week after treatment

    Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.