Upper Limb Spasticity (ULS)
Conditions
Brief summary
The purpose of this study is to explore how a rehabilitation tool (GripAble) could be used to monitor the effect of BoNT-A during an injection cycle and understand its potential value as a home rehabilitation tool in routine practice.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with hemiparesis with spasticity in the Primary Target Muscle Group (PTMG) for whom a decision to treat with BoNT-A has been made prior to inclusion in the study * BoNT-A injection must be administered in the PTMG; injection into additional upper limb muscles must be based on investigator's judgment in line with the relevant Summary of Product Characteristics (SmPC) * Naïve or non-naïve to BoNT-A treatment; if non-naïve, at least 4months elapsed after the last BoNT-A injection, of any marketed formulation prescribed in accordance to the relevant SmPC * Must be able to use the GripAble tool and have access to the internet through wireless connection in the home setting * Patients for whom the use of the GripAble tool aims to train: 1. Wrist extension, 2. Supination, 3. Grip and release
Exclusion criteria
* Surgery on any upper limb or intrathecal baclofen therapy (ITB) for spasticity within the last 3 months * Progressive neurological (e.g. Parkinson's Disease) * Patients with no active muscle recruitment in the affected upper limb * Patients with significant cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Physician Global Assessment (PGA) of treatment response scores in patients receiving BoNT-A for ULS during routine clinical practice. | At end of study (EOS) (between week 12 and week 20). | The assessment of the treatment response to BoNT-A therapy will be recorded on a nine-point scale (range -4: markedly worse to +4: markedly improved). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in MAS for Goal Attainment Scale (GAS)-T score | At end of study (between week 12 and week 20). | — |
| Changes from baseline in MAS for Passive Range of Motion (PROM) | At end of study (between week 12 and week 20) | — |
| Change from baseline in MAS for Active Range of Motion (AROM) | At end of study (between week 12 and week 20) | — |
| Changes from baseline in MAS | Time Frame: At end of study (between week 12 and week 20) | — |
| Changes from baseline in GAS-T score | At end of study (between week 12 and week 20 | — |
| Changes from baseline in PROM | At end of study (between week 12 and week 20 | — |
| Change from baseline in AROM | At end of study (between week 12 and week 20 | — |
| Changes from baseline in Modified Ashworth Scale (MAS) for Primary Target Muscle Group (PTMG). | At end of study (between week 12 and week 20). | — |
| Percentage of patients who achieved primary goal from GAS scaling | At end of study (EOS) (between week 12 and week 20) | — |
| Number of patients who set a primary goal per GAS | At baseline | — |
| Patient reported outcome of injection effectiveness on visual analogue scale (VAS) | Weekly basis up to end of study (between week 12 and week 20) | A record of injection effectiveness on VAS (of 0 to 100 \[bad to good\] |
| Patients reported outcomes of treatment effects. | Weekly basis up to end of study (between week 12 and week 20 | — |
| Dosing of BoNT-A administered | From baseline (first injection) to end of study (between week 12 and week 20) | A record of dosing, BoNT-A brand, localisation method, dose per muscle will be recorded by the physician at each injection. |
| Target muscles injected | From baseline (first injection) to end of study (between week 12 and week 20) | A record of the muscles injected at each injection. |
| Incidence of Adverse Events (AEs) or special situations | Up to 20 weeks | Assessed according to incidence, seriousness, intensity, causality, outcome and action taken |
| Change from baseline in MAS by muscle group irrespectively of PTMG. | At end of study (between week 12 and week 20 | — |
Countries
United Kingdom
Outcome results
None listed