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).

Completed

• Conditions: Upper Limb Spasticity (ULS)

• Registration Number: NCT05169775
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2021-12-27
• Study Start: 2022-03-02
• Status Verified: 2023-01
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)	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
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)

Trial Locations

Locations (1)

Hull University Teaching Hospital NHS Trust; 🇬🇧 Hull, United Kingdom