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

Sponsor

Ipsen (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05546190

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spastic Hemiparesis Muscle Spasticity

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 23, 2022

Anticipated Primary Completion Date :

Dec 23, 2022

Anticipated Study Completion Date :

Dec 23, 2023

Outcome Measures

Primary Outcome Measures

Number of participants answering to the questionnaire [First interview/ at baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical, Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT05546190

Other Study ID Numbers:

CLIN-10200-450

First Posted:

Sep 19, 2022

Last Update Posted:

Sep 19, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscle Spasticity

Paresis

Study Results

No Results Posted as of Sep 19, 2022