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NCT05887479
The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
Phase 4 trial testing Botulinum toxin type A in Cerebrovascular Disorders. Withdrawn.
15 July 2023
Quick facts
| Lead sponsor | Sisli Hamidiye Etfal Training and Research Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 25 May 2023 |
| Primary completion | 15 July 2023 |
| Estimated completion | 15 August 2023 |
Drugs / interventions tested
- Botulinum toxin type A (BOTULINUM TOXIN TYPE A) — full drug profile →
- %0,9 NaCl
Conditions studied
- Cerebrovascular Disorders — all drugs for Cerebrovascular Disorders →
- Spasticity, Muscle — all drugs for Spasticity, Muscle →
- Botulinum Toxin — all drugs for Botulinum Toxin →
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Who can join
Adults 35 to 80, any sex, with Cerebrovascular Disorders or Spasticity, Muscle. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The patients between the ages of 35-80 who developed spasticity in the upper extremity after stroke will be included.. Botulinum toxin(BT-A) injection will be applied to the study group(n=16) and placebo injection to the control group(n=15) in addition to conventional rehabilitation and stretching exercises. Evaluations will be made before the treatment, in the 2nd week, and in 3rd month after the treatment. Pain relief will be evaluated with the Visual Analog Scale(VAS) and spasticity assessment will be done with the Modified Ashworth Scale(MAS). The functionality will be evaluated with Fugl Meyer Assessment Scale(FMAS) and Box Block Test(BBT).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05887479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05887479 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sisli Hamidiye Etfal Training and Research Hospital
- Last refreshed: 22 November 2023
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/NCT05887479.
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