NCT03546959 is a NA clinical trial of Lycra sleeve in Stroke, sponsored by Marmara University.

Who is sponsoring NCT03546959?

NCT03546959 is sponsored by Marmara University.

What drugs are being tested in NCT03546959?

Interventions in NCT03546959: Lycra sleeve, Rehabilitation, Botulinum Toxin.

What condition does NCT03546959 study?

NCT03546959 studies Stroke, Spasticity as Sequela of Stroke, Upper Limb Hypertonia.

Is NCT03546959 still recruiting?

NCT03546959 is currently completed. Last updated 18 June 2019.

Last reviewed 2019-06-18 · How we verify

NCT03546959

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dynamic Lycra Orthosis as an Adjunct to Botulinum Toxin-A Injection for Post-stroke Spasticity

Completed NA Last updated 18 June 2019

What this trial tests

NA trial testing Lycra sleeve in Stroke in 20 participants. Completed in 11 February 2019.

Timeline

6 June 2018

Primary endpoint
11 February 2019

11 February 2019

Quick facts

Lead sponsor	Marmara University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	6 June 2018
Primary completion	11 February 2019
Estimated completion	11 February 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

Lycra sleeve
Rehabilitation
Botulinum Toxin — full drug profile →

Conditions studied

Stroke — all drugs for Stroke →
Spasticity as Sequela of Stroke — all drugs for Spasticity as Sequela of Stroke →
Upper Limb Hypertonia — all drugs for Upper Limb Hypertonia →

Sponsor

Marmara University

Who can join

Adults 18 to 80, female only, with Stroke or Spasticity as Sequela of Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Upper extremity splints are one of the nonpharmacologic treatments used to treat hypertonicity after stroke. The purpose of splinting is to support, to position, to immobilize, to prevent contracture and deformities, to reduce spasticity and to enhance function. Dynamic lycra splints have been found to improve spasticity, posture, and fluency of upper extremity movements in computerized analysis systems due to the effects of neutral warmth, circumferential pressure and by creating a low intensity prolonged stretch on hypertonic muscles , all of which contribute to increased sensory awareness of the involved limb. These splints are frequently used in the field of neurological rehabilitation, but there is not enough scientific evidence about their efficacy. It was demonstrated that lycra sleeves have positive effects on upper extremity function of children with cerebral palsy. Lycra sleeves for upper extremity function after stroke is a relatively new field of research. The aim of this study is to investigate effects of dynamic lycra orthosis as an adjunct to botulinum toxin-a injection of the upper limb in adults following stroke.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of dynamic lycra orthosis as an adjunct to rehabilitation after botulinum toxin-A injection of the upper-limb in adults following stroke: A single-blinded randomized controlled pilot study.
Giray E, Gencer Atalay K, Eren N, Gündüz OH, et al · · 2020 · cited 7× · PMID 31868130 · DOI 10.1080/10749357.2019.1704371

Verify or expand the search:

Other recruiting trials for Stroke

Currently open trials in the same condition.

NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke · recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment · NA · recruiting
NCT07356011 — Exoskeleton for Balance · NA · recruiting
NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in · NA · recruiting
NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients · NA · recruiting

Other Marmara University trials

Trials by the same sponsor.

NCT07533734 — The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke · NA · not yet recruiting
NCT07474181 — Simulation-Based Training for Urinary Catheterization Skills in Nursing Students · NA · not yet recruiting
NCT07486349 — Shoulder Pericapsular Block Versus Interscalene Block in Arthroscopic Shoulder Surgery · NA · not yet recruiting
NCT07468110 — Evaluation Of The Relationship Between The Conut Score And Balance And Functional Status In Patients With Chronic Stroke · recruiting
NCT07468097 — The Impact of Metabolic Status on Pain and Central Sensitization in Women With Lipedema: A Cross-Sectional Observational · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03546959 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Marmara University
Last refreshed: 18 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03546959.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing