Upper Limb Spasticity (ULS)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).
An observational study of Upper Limb Spasticity (ULS), run by Ipsen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Spasticity (ULS)
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2022to 4 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1 secondary care center in the UK.
Who may be able to join
- 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:
- Wrist extension,
- Supination,
- Grip and release
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Upper Limb Spasticity (ULS)
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: At end of study (between week 12 and week 20).
Changes from baseline in MAS for Goal Attainment Scale (GAS)-T score
Measured: At end of study (between week 12 and week 20).
Changes from baseline in MAS for Passive Range of Motion (PROM)
Measured: At end of study (between week 12 and week 20)
Change from baseline in MAS for Active Range of Motion (AROM)
Measured: At end of study (between week 12 and week 20)
Changes from baseline in MAS
Measured: Time Frame: At end of study (between week 12 and week 20)
Changes from baseline in GAS-T score
Measured: At end of study (between week 12 and week 20
Changes from baseline in PROM
Measured: At end of study (between week 12 and week 20
Change from baseline in AROM
Measured: At end of study (between week 12 and week 20
Change from baseline in MAS by muscle group irrespectively of PTMG.
Measured: At end of study (between week 12 and week 20
Percentage of patients who achieved primary goal from GAS scaling
Measured: At end of study (EOS) (between week 12 and week 20)
Number of patients who set a primary goal per GAS
Measured: 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]
Measured: Weekly basis up to end of study (between week 12 and week 20)
Patients reported outcomes of treatment effects.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start2 Mar 2022
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb Spasticity (ULS)Studies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169775
- Sponsor's protocol ID
- CLIN-52120-453
- Status last verified
- Sep 2025
- First submitted
- 23 Dec 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05169775
- Acronym / sponsor ID
- CLIN-52120-453
- Conditions
- Upper Limb Spasticity (ULS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1 secondary care center in the UK.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Physician Global Assessment (PGA) of treatment response scores in patients receiving BoNT-A for ULS during routine clinical practice.
Time frame: 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).
16 secondary outcomes
Changes from baseline in Modified Ashworth Scale (MAS) for Primary Target Muscle Group (PTMG).
Time frame: At end of study (between week 12 and week 20).
Changes from baseline in MAS for Goal Attainment Scale (GAS)-T score
Time frame: At end of study (between week 12 and week 20).
Changes from baseline in MAS for Passive Range of Motion (PROM)
Time frame: At end of study (between week 12 and week 20)
Change from baseline in MAS for Active Range of Motion (AROM)
Time frame: At end of study (between week 12 and week 20)
Changes from baseline in MAS
Time frame: Time Frame: At end of study (between week 12 and week 20)
Changes from baseline in GAS-T score
Time frame: At end of study (between week 12 and week 20
Changes from baseline in PROM
Time frame: At end of study (between week 12 and week 20
Change from baseline in AROM
Time frame: At end of study (between week 12 and week 20
Change from baseline in MAS by muscle group irrespectively of PTMG.
Time frame: At end of study (between week 12 and week 20
Percentage of patients who achieved primary goal from GAS scaling
Time frame: At end of study (EOS) (between week 12 and week 20)
Number of patients who set a primary goal per GAS
Time frame: At baseline
Patient reported outcome of injection effectiveness on visual analogue scale (VAS)
Time frame: Weekly basis up to end of study (between week 12 and week 20)
Patients reported outcomes of treatment effects.
Time frame: Weekly basis up to end of study (between week 12 and week 20
Dosing of BoNT-A administered
Time frame: From baseline (first injection) to end of study (between week 12 and week 20)
Target muscles injected
Time frame: From baseline (first injection) to end of study (between week 12 and week 20)
Incidence of Adverse Events (AEs) or special situations
Time frame: Up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publicationAbayomi 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Upper Limb Spasticity (ULS)
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection in the Treatment of Adult Upper Limb Spasticity .
Upper Limb Spasticity (ULS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Spasticity (ULS), run by Ipsen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Physician Global Assessment (PGA) of treatment response scores in patients receiving BoNT-A for ULS during routine clinical practice. (time frame: At end of study (EOS) (between week 12 and week 20).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.