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The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity

NCT ID: NCT05887479

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2023-08-15

Brief Summary

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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).

Detailed Description

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Conditions

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Cerebrovascular Disorders Spasticity, Muscle Botulinum Toxin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Study Group

This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given.

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

Toxin of Clostridium Botulinum

Control Group

This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given.

Group Type PLACEBO_COMPARATOR

%0,9 NaCl

Intervention Type DRUG

%0,9 NaCl

Interventions

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Botulinum toxin type A

Toxin of Clostridium Botulinum

Intervention Type DRUG

%0,9 NaCl

%0,9 NaCl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* hemiplegia due to a cerebrovascular accident at least 1 month ago
* cognitively competent
* have spasticity of 1 and above according to the Modified Ashworth Scale
* receive at least 3 cubes in the Box Block Test

Exclusion Criteria

* Patients with upper extremity brachial plexus lesions,
* shoulder subluxation,
* arthritis and joint contracture,
* neglect syndrome,
* cerebellar and brain stem lesions
* those who did not accept the study
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aylin Ayyıldız

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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042023

Identifier Type: -

Identifier Source: org_study_id