A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)

Muscle Spasticity Clinical Trial

Official title:

Non-interventional Study to Assess the Arm Activity Measure Questionnaire (ArmA) by Patients With Adult Upper Limb (AUL) Spasticity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546190
• Other study ID #: CLIN-10200-450
• Status: Completed
• Start date: September 20, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: April 2023
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Paresis
• Spastic Hemiparesis

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehab	Downey	California
United States	MedStar National Rehabilitation Network	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants answering to the questionnaire: for Part 1 15/15 subject		First interview/ at baseline