Spasticity, MuscleROM-ICTUSNCT05151874
Valuation of the Evolution of Passive Mobility in the Spastic Upper Limb After Injection of Abobotulinumtoxin(Dysport®)
An observational study of Spasticity, Muscle and Stroke Sequelae, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Assessing the objective measurement of passive joint mobility (ROM) in the spastic upper limb with Jost's pattern III in patients with post-stroke spasticity after infiltration with BoNT-A allows to objectify the increase in passive joint balance (ROM). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Spasticity, Muscle, Stroke Sequelae, Movement Disorders
- What is being tested?
- Abobotulinum toxin A
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2022to Dec 2022
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18 years. Hemiplegic patients with post-stroke upper limb spasticity affected by pattern III1 who have undergone at least 2 cycles of previous treatment with BoNT-A Patients with a MAS scale (Modified Ashworth Scale) between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal. Patients with Hackett ultrasound qualitative scale between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
Who may be able to join
- Patients aged ≥ 18 years.
- Hemiplegic patients with post-stroke upper limb spasticity affected by pattern III1 who have undergone at least 2 cycles of previous treatment with BoNT-A
- Patients with a MAS scale (Modified Ashworth Scale) between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
- Patients with Hackett ultrasound qualitative scale between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
Who cannot join
- Patients who do not wish to sign the informed consent.
- Prior lack of primary or secondary response to any BoNT-A for any specific condition or known sensitivity to BoNT-A or any excipient.
- Routine or prescribed treatment with any medication that directly or indirectly interferes with neuromuscular function in the last 3 months prior to study botulinum toxin treatment.
- Having undergone surgery on the muscles, ligaments, tendons, nerves or bones of the limb to be treated.
- Any medical condition or analytical finding that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of the study protocol or exclude the administration of BoNT-A.
- Treatment with an investigational new drug in the 4 weeks or 5 half-lives prior to screening to enter the study.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Helena Bascuñana, Dr, +34 935537059, hbascunana@santpau.cat
Eliot Ramirez, Dr, +34 935537059, eramirezm@santpau.cat
About this study
Official title: Valuation of the Evolution of Passive Mobility (ROM)in the Spastic Upper Limb After Injection of Abobotulinumtoxin(Dysport®) in Patients With Post-stroke Spasticity
Assessing the objective measurement of passive joint mobility (ROM) in the spastic upper limb with Jost's pattern III in patients with post-stroke spasticity after infiltration with BoNT-A allows to objectify the increase in passive joint balance (ROM).
Read the detailed description
Changes in joint mobility in patients with post-stroke upper limb spasticity after infiltration of botulinum toxin type A.
The spasticity pattern that will be evaluated will be pattern number III based on the classification of Jost et al. Joint mobility will be measured with the Lynx instrument (DyCare)
- Conditions
- Spasticity, Muscle, Stroke Sequelae, Movement Disorders
- Being tested
- Abobotulinum toxin A
- Keywords
- Spasticity, Abobotulinum toxin, Injection, Rehabilitation
- Medical subject headings
- Muscle Spasticity, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abobotulinum toxin ADrug
Also called toxin infiltration
To measure ROM evolution in patients with post-stroke spasticity in the upper limb with spasticity pattern III.
| Study group | Role | What they receive |
|---|---|---|
| Range of movement | Change in passive joint mobility (ROM) of the carpus (flexion-extension) affected by spasticity pattern III during a 20-week follow-up. Receives: Drug: Abobotulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in passive range of motion
Change in passive joint mobility (ROM) of the upper limb affected by spasticity pattern III a 20-week follow-up.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151874
- Sponsor's protocol ID
- IIBSP-ROM-2020-135
- Acronym
- ROM-ICTUS
- Status last verified
- Nov 2021
- First submitted
- 6 Aug 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of the Evolution of Passive Mobility (ROM)in the Spastic Upper Limb After Injection of Abobotulinumtoxin(Dysport®) in Patients With Post-stroke Spasticity
- ClinicalTrials.gov ID
- NCT05151874
- Acronym / sponsor ID
- ROM-ICTUS / IIBSP-ROM-2020-135
- Conditions
- Spasticity, Muscle, Stroke Sequelae, Movement Disorders
- Keywords
- Spasticity, Abobotulinum toxin, Injection, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
Assessing the objective measurement of passive joint mobility (ROM) in the spastic upper limb with Jost's pattern III in patients with post-stroke spasticity after infiltration with BoNT-A allows to objectify the increase in passive joint balance (ROM).
Detailed description
Changes in joint mobility in patients with post-stroke upper limb spasticity after infiltration of botulinum toxin type A.
The spasticity pattern that will be evaluated will be pattern number III based on the classification of Jost et al. Joint mobility will be measured with the Lynx instrument (DyCare)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Range of movement | – | Drug: Abobotulinum toxin AChange in passive joint mobility (ROM) of the carpus (flexion-extension) affected by spasticity pattern III during a 20-week follow-up. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18 years. Hemiplegic patients with post-stroke upper limb spasticity affected by pattern III1 who have undergone at least 2 cycles of previous treatment with BoNT-A Patients with a MAS scale (Modified Ashworth Scale) between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal. Patients with Hackett ultrasound qualitative scale between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years.
- Hemiplegic patients with post-stroke upper limb spasticity affected by pattern III1 who have undergone at least 2 cycles of previous treatment with BoNT-A
- Patients with a MAS scale (Modified Ashworth Scale) between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
- Patients with Hackett ultrasound qualitative scale between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
Key exclusion criteria (7 listed)
- Patients who do not wish to sign the informed consent.
- Prior lack of primary or secondary response to any BoNT-A for any specific condition or known sensitivity to BoNT-A or any excipient.
- Routine or prescribed treatment with any medication that directly or indirectly interferes with neuromuscular function in the last 3 months prior to study botulinum toxin treatment.
- Having undergone surgery on the muscles, ligaments, tendons, nerves or bones of the limb to be treated.
- Any medical condition or analytical finding that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of the study protocol or exclude the administration of BoNT-A.
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 |
|---|---|---|
| Abobotulinum toxin AAlso: toxin infiltrationTo measure ROM evolution in patients with post-stroke spasticity in the upper limb with spasticity pattern III. | Drug | Range of movement |
Primary outcome
Change in passive range of motion
Time frame: Through study completion, an average of 1 year
Change in passive joint mobility (ROM) of the upper limb affected by spasticity pattern III a 20-week follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, Muscle and Stroke Sequelae, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 7 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in passive range of motion (time frame: Through study completion, an average of 1 year). 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 9 Dec 2021.