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).

Ipsen

Status: Completed

Conditions: Upper Limb Spasticity (ULS)

Study type: Observational

Funder types: Industry

Identifiers

NCT05169775

CLIN-52120-453

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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