Spastic HemiparesisNCT05546190
A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)
An observational study of Spastic Hemiparesis and Muscle Spasticity, run by Ipsen at 2 sites in United States.
Trial summary
The participants of this study will have AUL spasticity and have a need for botulinum toxin type A injections. AUL spasticity is where people develop tightening or stiffness of the muscles in the arms. Botulinum toxin type A is used for the treatment of spasticity in addition to physiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spastic Hemiparesis, Muscle Spasticity
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2022to 23 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are at least 18 years old, able to read and communicate fluently in English and have a clinical diagnosis of spastic hemiparesis following stroke or traumatic brain injury (TBI). They must be at least 6 months post-stroke or TBI and have AUL in both arms that requires botulinum toxin type A injections as part of their AUL spasticity treatment. Additionally, participants are required to be in a stable state regarding their therapeutic interventions (i.e., at least one month prior to assessment of eligibility) and have no other clinically relevant concerns that would hinder their ability to provide written informed consent and/or participate.
Who may be able to join
- Participant has provided informed consent and is willing to take part in the study
- Participant is an adult aged at least 18 years
- Participant has a clinical diagnosis of spastic hemiparesis following stroke or traumatic brain injury (TBI) affecting one arm only
- Participant is at least 6 months post-stroke or TBI
- Participant has a need for botulinum toxin type A injections as part of their treatment for AUL spasticity
- Patient is considered to be in a stable state with regard to their therapeutic interventions (i.e., all treatments for the patient's condition have been stable for at least one month prior to assessment of eligibility)
- Participant has access to the internet, laptop, or tablet, and is willing to take part in either an online focus group or interview (caregiver assistance is acceptable)
- Participant is fluent in the English language and is able to discuss their condition
Who cannot join
- Participant has any medical condition that prohibits their ability to communicate with the interviewer including severe dysphasia or an inability to read questionnaires.
- Participant has any other clinically relevant concern (e.g., significant psychiatric disorder or depression, history of alcohol and/or drug abuse) that in your opinion would interfere with their ability to provide written informed consent and/or participate.
- Participant has AUL spasticity is present in both arms
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rancho Los Amigos National Rehab
Downey, California, 90242
MedStar National Rehabilitation Network
Washington D.C., District of Columbia, 20010
About this study
Official title: Non-interventional Study to Assess the Arm Activity Measure Questionnaire (ArmA) by Patients With Adult Upper Limb (AUL) Spasticity.
The participants of this study will have AUL spasticity and have a need for botulinum toxin type A injections. AUL spasticity is where people develop tightening or stiffness of the muscles in the arms. Botulinum toxin type A is used for the treatment of spasticity in addition to physiotherapy. This study will ask participants to describe their experience living with AUL spasticity. This information will be used to assess the Arm Activity Measure (ArmA). ArmA is a scale designed to assess upper limb function in people with AUL spasticity. This study could suggest changes to the ArmA to improve its suitability for people with AUL spasticity or even the development of a new scale.
- Conditions
- Spastic Hemiparesis, Muscle Spasticity
- Medical subject headings
- Hemiplegia, Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants answering to the questionnaire: for Part 1 15/15 subject
Measured: First interview/ at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start20 Sep 2022
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic HemiparesisStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Other
- Time perspective
- Other
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical, Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546190
- Sponsor's protocol ID
- CLIN-10200-450
- Status last verified
- Apr 2023
- First submitted
- 16 Sep 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Assess the Arm Activity Measure Questionnaire (ArmA) by Patients With Adult Upper Limb (AUL) Spasticity.
- ClinicalTrials.gov ID
- NCT05546190
- Acronym / sponsor ID
- CLIN-10200-450
- Conditions
- Spastic Hemiparesis, Muscle Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 19 Sep 2022 (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 participants of this study will have AUL spasticity and have a need for botulinum toxin type A injections. AUL spasticity is where people develop tightening or stiffness of the muscles in the arms. Botulinum toxin type A is used for the treatment of spasticity in addition to physiotherapy. This study will ask participants to describe their experience living with AUL spasticity. This information will be used to assess the Arm Activity Measure (ArmA). ArmA is a scale designed to assess upper limb function in people with AUL spasticity. This study could suggest changes to the ArmA to improve its suitability for people with AUL spasticity or even the development of a new scale.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are at least 18 years old, able to read and communicate fluently in English and have a clinical diagnosis of spastic hemiparesis following stroke or traumatic brain injury (TBI). They must be at least 6 months post-stroke or TBI and have AUL in both arms that requires botulinum toxin type A injections as part of their AUL spasticity treatment. Additionally, participants are required to be in a stable state regarding their therapeutic interventions (i.e., at least one month prior to assessment of eligibility) and have no other clinically relevant concerns that would hinder their ability to provide written informed consent and/or participate.
Key inclusion criteria (8 listed)
- Participant has provided informed consent and is willing to take part in the study
- Participant is an adult aged at least 18 years
- Participant has a clinical diagnosis of spastic hemiparesis following stroke or traumatic brain injury (TBI) affecting one arm only
- Participant is at least 6 months post-stroke or TBI
- Participant has a need for botulinum toxin type A injections as part of their treatment for AUL spasticity
Key exclusion criteria (3 listed)
- Participant has any medical condition that prohibits their ability to communicate with the interviewer including severe dysphasia or an inability to read questionnaires.
- Participant has any other clinically relevant concern (e.g., significant psychiatric disorder or depression, history of alcohol and/or drug abuse) that in your opinion would interfere with their ability to provide written informed consent and/or participate.
- Participant has AUL spasticity is present in both arms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants answering to the questionnaire: for Part 1 15/15 subject
Time frame: First interview/ at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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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.
Ipsen Medical, Director study director
Ipsen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Hemiparesis and Muscle Spasticity, run by Ipsen at 2 sites in United States.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants answering to the questionnaire: for Part 1 15/15 subject (time frame: First interview/ at baseline). 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 18 Apr 2023.