Skip to main content
OpenTrials
Completed

NCT Number: 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).

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Upper Limb Spasticity (ULS)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hull University Teaching Hospital NHS Trust

Hull, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Wrist extension,
  • Supination,
  • 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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. Changes from baseline in MAS for Goal Attainment Scale (GAS)-T score

    Time frame: At end of study (between week 12 and week 20).

  3. Changes from baseline in MAS for Passive Range of Motion (PROM)

    Time frame: At end of study (between week 12 and week 20)

  4. Change from baseline in MAS for Active Range of Motion (AROM)

    Time frame: At end of study (between week 12 and week 20)

  5. Changes from baseline in MAS

    Time frame: Time Frame: At end of study (between week 12 and week 20)

  6. Changes from baseline in GAS-T score

    Time frame: At end of study (between week 12 and week 20

  7. Changes from baseline in PROM

    Time frame: At end of study (between week 12 and week 20

  8. Change from baseline in AROM

    Time frame: At end of study (between week 12 and week 20

  9. Change from baseline in MAS by muscle group irrespectively of PTMG.

    Time frame: At end of study (between week 12 and week 20

  10. Percentage of patients who achieved primary goal from GAS scaling

    Time frame: At end of study (EOS) (between week 12 and week 20)

  11. Number of patients who set a primary goal per GAS

    Time frame: At baseline

  12. 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)

    A record of injection effectiveness on VAS (of 0 to 100 [bad to good]

  13. Patients reported outcomes of treatment effects.

    Time frame: Weekly basis up to end of study (between week 12 and week 20

  14. Dosing of BoNT-A administered

    Time frame: 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.

  15. Target muscles injected

    Time frame: From baseline (first injection) to end of study (between week 12 and week 20)

    A record of the muscles injected at each injection.

  16. Incidence of Adverse Events (AEs) or special situations

    Time frame: Up to 20 weeks

    Assessed according to incidence, seriousness, intensity, causality, outcome and action taken

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2021
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.