NCT06362954

Brief Summary

Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity influences muscle hemodynamic and oxidative metabolism, but its impact on the balance between oxygen delivery and utilization is not well understood. This study study aims to investigate the effect of spasticity severity on peripheral muscle oxygenation in patients with hemiparetic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

April 9, 2024

Last Update Submit

May 17, 2025

Conditions

Keywords

strokeparesisspasticitynear-infrared spectroscopylower extremity

Outcome Measures

Primary Outcomes (2)

  • Gastrocnemius Muscle Oxygenation

    Gastrocnemius muscle oxygenation will be evaluated with Near-Infrared Spectroscopy at rest, during and after the 6-Minute Walk Test (6MWT) and the Stair Climbing Test (SCT).

    Day 1

  • Spasticity

    Plantar flexor muscle spasticity on the affected side will be evaluated with Modified Ashworth Scale

    Day 1

Secondary Outcomes (5)

  • Motor Function

    Day 1

  • Disability Level

    Day 1

  • 6-Minute Walk Test

    Day 1

  • Stair Climbing Test

    Day 1

  • Adipose tissue thickness

    Day 1

Study Arms (3)

High-Level Spasticity Group

Hemiparetic stroke patients with spasticity levels greater than or equal 2 on the Modified Ashworth Scale.

Low-Level Spasticity Group

Hemiparetic stroke patients with spasticity levels less than 2 on the Modified Ashworth Scale.

Control Group

Healthy individuals were included in the control group.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty patients with chronic hemiparetic stroke and 10 healthy controls was conducted at Gazi University, Faculty of Health Sciences, Outpatient Clinics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Suicmez S, Yazici G, Altiparmak T, Cagatay C, Batur-Caglayan HZ, Nazliel B. The effect of spasticity severity on peripheral muscle oxygenation in hemiparetic stroke patients: a cross-sectional study. Top Stroke Rehabil. 2025 Jul 28:1-11. doi: 10.1080/10749357.2025.2538520. Online ahead of print.

MeSH Terms

Conditions

StrokeParesisMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular Manifestations

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 12, 2024

Study Start

April 15, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations