A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)
Non-interventional Study to Assess the Arm Activity Measure Questionnaire (ArmA) by Patients With Adult Upper Limb (AUL) Spasticity.
1 other identifier
observational
25
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2022
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedStudy Start
First participant enrolled
September 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2023
CompletedApril 18, 2023
April 1, 2023
6 months
September 16, 2022
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants answering to the questionnaire: for Part 1 15/15 subject
First interview/ at baseline
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (2)
Rancho Los Amigos National Rehab
Downey, California, 90242, United States
MedStar National Rehabilitation Network
Washington D.C., District of Columbia, 20010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical, Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 19, 2022
Study Start
September 20, 2022
Primary Completion
March 23, 2023
Study Completion
March 23, 2023
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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.