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

NCT ID: NCT05546190

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2023-03-23

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.

Conditions

Spastic Hemiparesis; Muscle Spasticity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical, Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Rancho Los Amigos National Rehab

Downey, California, United States

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

CLIN-10200-450

Identifier Type: -

Identifier Source: org_study_id