Cerebrovascular DisordersPhase 4NCT05887479
The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
A Phase 4 study testing Botulinum toxin type A and %0,9 NaCl in people with Cerebrovascular Disorders and Spasticity, Muscle, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cerebrovascular Disorders, Spasticity, Muscle, Botulinum Toxin
- What is being tested?
- Botulinum toxin type A and %0,9 NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2023to 15 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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).
- Being tested
- Botulinum toxin type A, %0,9 NaCl
- Medical subject headings
- Cerebrovascular Disorders, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toxin of Clostridium Botulinum
%0,9 NaClDrug
%0,9 NaCl
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given. Receives: Drug: Botulinum toxin type A |
| Control Group | Placebo comparator | This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given. Receives: Drug: %0,9 NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Visual Analog Scale
The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation.
Measured: 2 weeks after treatment
Range of Motion
Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension.
Measured: 2 weeks after treatment
Modified Ashworth Scale
The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position.
Measured: 2 weeks after treatment
The Fugl-Meyer assessment scale
The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.
Measured: 2 weeks after treatment
Secondary outcomes (4)
Pain - Visual Analog Scale
The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation.
Measured: 3 months after treatment
Range of Motion
Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension.
Measured: 3 months after treatment
Modified Ashworth Scale
The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position.
Measured: 3 months after treatment
The Fugl-Meyer assessment scale
The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start25 May 2023 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Why it stopped: insufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887479
- Sponsor's protocol ID
- 042023
- Status last verified
- Nov 2023
- First submitted
- 9 Apr 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
- ClinicalTrials.gov ID
- NCT05887479
- Acronym / sponsor ID
- 042023
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient number of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 25 May 2023 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Drug: Botulinum toxin type AThis is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given. |
| Control Group | Placebo comparator | Drug: %0,9 NaClThis is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with upper extremity brachial plexus lesions,
- shoulder subluxation,
- arthritis and joint contracture,
- neglect syndrome,
- cerebellar and brain stem lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AToxin of Clostridium Botulinum | Drug | Study Group |
| %0,9 NaCl%0,9 NaCl | Drug | Control Group |
Primary outcome
Pain - Visual Analog Scale
Time frame: 2 weeks after treatment
The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation.
Range of Motion
Time frame: 2 weeks after treatment
Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension.
Modified Ashworth Scale
Time frame: 2 weeks after treatment
The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position.
The Fugl-Meyer assessment scale
Time frame: 2 weeks after treatment
The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.
4 secondary outcomes
Pain - Visual Analog Scale
Time frame: 3 months after treatment
Range of Motion
Time frame: 3 months after treatment
Modified Ashworth Scale
Time frame: 3 months after treatment
The Fugl-Meyer assessment scale
Time frame: 3 months after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A and %0,9 NaCl in people with Cerebrovascular Disorders and Spasticity, Muscle, run by Sisli Hamidiye Etfal Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - Visual Analog Scale (time frame: 2 weeks after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.