To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke

Conditions

Muscle Spasticity

Brief summary

The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.

Raymond L. Rosales, Nicholas V.C. Chia, Witsanu Kumthornthip, Khean Jin Goh, Choon Soon Mak et al. (13 authors)

Frontiers in Neurology2024-04-082 citations

10.3389/fneur.2024.1335365

[Treatment goals in patients with post-stroke upper limb spasticity following injection of botulinum toxin A : Results of the German-Austrian subgroup of the ULIS-II study].

Fheodoroff K, Dressler D, Woldag H, Koßmehl P, Koch M, Maisonobe P, Reichel G.

2019-04-011 citations

10.1007/s00115-018-0630-1

Selected abstracts from the 12th International Society of Physical and Rehabilitation Medicine World Congress - ISPRM 2018

Boyer, François, Picaut, Philippe, Maosinobe, Pascal, Balcaitiene, Jovita, Lejeune, Thierry et al. (6 authors)

The Journal of the International Society of Physical and Rehabilitation Medicine2018-07-01

10.4103/2349-7904.236308

Results from the Upper Limb International Spasticity Study-II (ULIS-II): a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management

Lynne Turner‐Stokes, Klemens Fheodoroff, Jorge Jacinto, Pascal Maisonobe

BMJ Open2013-06-0194 citations

10.1136/bmjopen-2013-002771

Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice.

Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P, Zakine B.

2013-03-1829 citations

10.1136/bmjopen-2012-002230

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Upper limb spasticity following stroke * At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion * Decision already been agreed to inject BoNT-A * Agreement with the subject on goal setting

Exclusion criteria

* Contraindications to any BoNT-A preparations

Design outcomes

Primary

Measure	Time frame
Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices	Around 3 to 5 months post injection

Secondary

Measure	Time frame
Overall attainment of the treatment goals using the GAS T score	Around 3 to 5 months post injection
Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)	Around 3 to 5 months post injection
Global assessment of benefits by both the investigator and the subject (or guardian)	Around 3 to 5 months post injection

Countries

Australia, Austria, Belgium, China, Czechia, Denmark, Finland, France, Germany, Italy, Malaysia, Mexico, Philippines, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom

Outcome results