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).

Ipsen16 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Upper Limb Spasticity (ULS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hull University Teaching Hospital NHS Trust

Hull, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: At end of study (EOS) (between week 12 and week 20).

Secondary Outcomes

Changes from baseline in Modified Ashworth Scale (MAS) for Primary Target Muscle Group (PTMG).

Time frame: At end of study (between week 12 and week 20).

Changes from baseline in MAS for Goal Attainment Scale (GAS)-T score

Time frame: At end of study (between week 12 and week 20).

Changes from baseline in MAS for Passive Range of Motion (PROM)

Time frame: At end of study (between week 12 and week 20)

Change from baseline in MAS for Active Range of Motion (AROM)

Time frame: At end of study (between week 12 and week 20)

Changes from baseline in MAS

Time frame: Time Frame: At end of study (between week 12 and week 20)

Changes from baseline in GAS-T score

Time frame: At end of study (between week 12 and week 20

Changes from baseline in PROM

Time frame: At end of study (between week 12 and week 20

Change from baseline in AROM

Time frame: At end of study (between week 12 and week 20

Data from ClinicalTrials.gov

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