Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-… (NCT02969356) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)
United States157 participantsStarted 2016-12-18
Plain-language summary
The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects aged at least the national legal adult age.
* Subjects with hemiparesis due to acquired brain injury (ABI) presenting with muscle overactivity impeding motor function based on investigator's judgement including, but not limited to, at least one of the following requiring botulinum neurotoxin (BoNT) treatment: typical clenched fist; flexed wrist; flexed elbow; or plantar flexed foot pattern.
* At least 12 months since the ABI (i.e. stroke or traumatic brain injury (TBI)).
* Naïve or non-naïve to BoNT treatment; if non-naïve, at least 4 months after the last BoNT injection, of any serotype.
* Upper limb active function with an overall score between 2 and 7, as assessed by Modified Frenchay Scale (MFS), if the primary TT limb is the upper limb (UL).
* A 10-metre maximal WS barefoot between 0.2 and 1.4 m/s, if the primary TT limb is the lower limb (LL). Maximal WS barefoot will be performed without walking aids. However, a cane may be permitted if absolutely necessary (although this may prevent detection of treatment-induced improvements). In this case, the same aid will have to be used for all WS assessments during the study.
* Subjects must provide written informed consent to participate in the study prior to any study-related procedures.
* Female subjects of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration…
What they're measuring
1
Percentage of Responder Participants at Week 6 After the Second Injection, According to Composite Active Range of Motion (AROM) in the Primary TT Limb