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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.
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| 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). |
| 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). |
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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:
Exclusion Criteria:
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1 secondary care center in the UK.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull University Teaching Hospital NHS Trust | Hull | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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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.
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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.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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| 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 |