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).
1 other identifier
observational
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 27, 2021
CompletedStudy Start
First participant enrolled
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2023
CompletedSeptember 19, 2025
September 1, 2025
10 months
December 23, 2021
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
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)
- +11 more secondary outcomes
Eligibility Criteria
1 secondary care center in the UK.
You may qualify if:
- 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:
- Wrist extension,
- Supination,
- Grip and release
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (1)
Hull University Teaching Hospital NHS Trust
Hull, United Kingdom
Related Publications (1)
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.
RESULT
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2021
First Posted
December 27, 2021
Study Start
March 2, 2022
Primary Completion
January 4, 2023
Study Completion
January 4, 2023
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- 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.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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.