GripAble rehabilitation tool use in patients with ULS receiving BoNTA
Research type
Research Study
Full title
A SINGLE CENTRE, PROSPECTIVE, OBSERVATIONAL STUDY TO ASSESS THE USE OF THE REHABILITATION TOOL, GRIPABLE,ON PATIENTS WITH UPPER LIMB SPASTICITY RECEIVING BOTULINUM TOXIN A (BoNT-A) IN THE UK
IRAS ID
299256
Contact name
Abayomi Salawu
Contact email
Sponsor organisation
Ipsen
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 8 months, 3 days
Research summary
Ipsen would like to run an observational study at the specialist rehabilitation unit at Hull University Teaching Hospitals (HUTH) NHS Trust in the United Kingdom (UK). The aim of the study is to assess how the GripAble tool could be used to monitor the effect of Botulinum Toxin A products during one injection cycle and to understand its potential value as a home rehabilitation tool in routine practice.
This study seeks to enroll 20 adult patients diagnosed with upper limb spasticity from the HUTH. Patients will be followed-up for only one injection cycle of Botulinum toxin type A products. During this cycle, each patient will have one initial visit at the clinic on the day of the injection, then a final visit that can happen at any time between 12-20 weeks post injection. One patient cannot be followed-up for more than 20 weeks.
Data for this study will be collected from the patient medical records, directly from patients in the form patient questionnaires and electronically from the rehabilitation tool.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0092
Date of REC Opinion
8 Sep 2021
REC opinion
Further Information Favourable Opinion