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).

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.

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 Overview

• Status: Completed
• Conditions: Upper Limb Spasticity (ULS)

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United Kingdom
  • Hull, United Kingdom
    • Hull University Teaching Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1 secondary care center in the UK.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Publications and helpful links

General Publications

• Abayomi Salawu, Sharah Abdul Mutalib, Anthony Cosgrove, Vadim Degtiar, Anne-Sophie Grandoulier, Helena MacCarthy-Ielo, Sharon Scott, Mario Ippolito. Single-Center, Prospective, Observational Study to Assess the Use the Rehabilitation Tool, GripAble, in Adults With Upper Limb Spasticity Receiving Botulinum Neurotoxin Type A in the UK. Toxicon, January 2024, Volume 237, Supplement 1, 107484.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: CLIN-52120-453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No