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

NCT07083752 | Completed

• 1 other identifier: AIBU-FTR-SK-10
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemiplegia; Spasticity, Muscle

Outcome Measures

Primary Outcomes (4)

• Muscle Thickness

  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.

  Before treatment

• Muscle Thickness

  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.

  4 week after treatment

• Brunnstrom Motor Recovery Stages

  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.

  Before treatment

• Brunnstrom Motor Recovery Stages

  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 week after treatment

Secondary Outcomes (2)

• Modified Ashworth Scale

  Before treatment

• Modified Ashworth Scale

  4 week after treatment

Interventions

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.

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study was designed as a retrospective cross-sectional study. The study included patients who had been hospitalized at İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital with a diagnosis of hemiplegia due to stroke, had participated in a rehabilitation program, had given informed consent previously, and had received botulinum toxin injections to their upper extremities.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, 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: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start: July 13, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)