Clinical trial NCT05169775: 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).
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Limb Spasticity (ULS)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1 secondary care center in the UK.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Physician Global Assessment (PGA) of treatment response scores in patients receiving BoNT-A for ULS during routine clinical practice.
timeFrame: At end of study (EOS) (between week 12 and week 20).
Secondary outcomes:
measure: Changes from baseline in Modified Ashworth Scale (MAS) for Primary Target Muscle Group (PTMG).
timeFrame: At end of study (between week 12 and week 20).
measure: Changes from baseline in MAS for Goal Attainment Scale (GAS)-T score
timeFrame: At end of study (between week 12 and week 20).
measure: Changes from baseline in MAS for Passive Range of Motion (PROM)
timeFrame: At end of study (between week 12 and week 20)
measure: Change from baseline in MAS for Active Range of Motion (AROM)
timeFrame: At end of study (between week 12 and week 20)
measure: Changes from baseline in MAS
timeFrame: Time Frame: At end of study (between week 12 and week 20)
measure: Changes from baseline in GAS-T score
timeFrame: At end of study (between week 12 and week 20
measure: Changes from baseline in PROM
timeFrame: At end of study (between week 12 and week 20
measure: Change from baseline in AROM
timeFrame: At end of study (between week 12 and week 20
measure: Change from baseline in MAS by muscle group irrespectively of PTMG.
timeFrame: At end of study (between week 12 and week 20
measure: Percentage of patients who achieved primary goal from GAS scaling
timeFrame: At end of study (EOS) (between week 12 and week 20)
measure: Number of patients who set a primary goal per GAS
timeFrame: At baseline
measure: Patient reported outcome of injection effectiveness on visual analogue scale (VAS)
timeFrame: Weekly basis up to end of study (between week 12 and week 20)
measure: Patients reported outcomes of treatment effects.
timeFrame: Weekly basis up to end of study (between week 12 and week 20
measure: Dosing of BoNT-A administered
timeFrame: From baseline (first injection) to end of study (between week 12 and week 20)
measure: Target muscles injected
timeFrame: From baseline (first injection) to end of study (between week 12 and week 20)
measure: Incidence of Adverse Events (AEs) or special situations
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospital NHS Trust
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: