A Single Centre, Prospective, Observational Study to Assess the Use of the Rehabilitation Tool, GripAble, in Patients With Upper Limb Spasticity Receiving Botulinum Toxin-A (BoNT-A) in the United Kingdom (UK).

Study Overview
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Brief Summary
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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.

Official Title
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A Single Centre, Prospective, Observational Study to Assess the Use of the Rehabilitation Tool, GripAble, in Patients With Upper Limb Spasticity Receiving Botulinum Toxin-A (BoNT-A) in the UK.

Conditions
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Upper Limb Spasticity (ULS)

Participation Criteria
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Eligibility Criteria
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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: Wrist extension, Supination, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Physician Global Assessment (PGA) of treatment response scores in patients receiving BoNT-A for ULS during routine clinical practice. | 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). | At end of study (EOS) (between week 12 and week 20). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Modified Ashworth Scale (MAS) for Primary Target Muscle Group (PTMG). |  | At end of study (between week 12 and week 20). | 
| 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 | 
| Change from baseline in MAS by muscle group irrespectively of 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) | A record of injection effectiveness on VAS (of 0 to 100 [bad to good] | Weekly basis up to end of study (between week 12 and week 20) | 
| Patients reported outcomes of treatment effects. |  | Weekly basis up to end of study (between week 12 and week 20 | 
| Dosing of BoNT-A administered | A record of dosing, BoNT-A brand, localisation method, dose per muscle will be recorded by the physician at each injection. | From baseline (first injection) to end of study (between week 12 and week 20) | 
| Target muscles injected | A record of the muscles injected at each injection. | From baseline (first injection) to end of study (between week 12 and week 20) | 
| Incidence of Adverse Events (AEs) or special situations | Assessed according to incidence, seriousness, intensity, causality, outcome and action taken | Up to 20 weeks |