Clinical trial NCT05546190: A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)
Official title: Non-interventional Study to Assess the Arm Activity Measure Questionnaire (ArmA) by Patients With Adult Upper Limb (AUL) Spasticity.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spastic Hemiparesis
Muscle Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Inclusion Criteria :

* 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

Exclusion Criteria :

* 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

Primary outcomes:
measure: Number of participants answering to the questionnaire: for Part 1 15/15 subject
timeFrame: First interview/ at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehab
state: California
city: Washington
country: United States
facility: MedStar National Rehabilitation Network
state: District of Columbia
Study officials:
affiliation: Ipsen
name: Ipsen Medical, Director
role: STUDY_DIRECTOR
References: