INTENSE
Research type
Research Study
Full title
Is intensive upper limb rehabilitation effective in chronic stroke patients? A randomised controlled trial (INTENSE)
IRAS ID
299687
Contact name
Nick Ward
Contact email
Sponsor organisation
University College London/UCLH
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Data Protection, Z6364106/2021/10/86
Duration of Study in the UK
3 years, 3 months, 30 days
Research summary
The evidence supporting routine provision of high-dose, high-intensity upper limb neurorehabilitation treatment for stroke survivors beyond the first few months after stroke is weak. The Queen Square Upper Limb (QSUL) programme provides 90 hours of upper limb neurorehabilitation over 3-weeks to chronic stroke survivors. The
recently published service evaluation demonstrated encouragingly large, clinically meaningful effects on activity and body function. An alternative way to deliver high doses of effective therapy is through technological developments, e.g. interventions using robotic technology in immersive environments such as the Mindpod dolphin programme. The primary aim of this study is to provide stronger level evidence of these effects from intensive upper limb rehabilitation by conducting a randomised controlled trial. Patients considered suitable for the QSUL programme will
be randomised to either: Group 1- intensive upper limb rehabilitation programme; Group 2- Mindpod/dolphin programme; Group 3-wait-list control (who will be offered the treatment after the waiting list is complete). The primary outcome score will be the upper limb movement at 3 months after the programme is complete.
The secondary aims are to comply with recent recommended by the Stroke Recovery and Rehabilitation Roundtable, and (i) investigate the effects of upper limb neurorehabilitation on kinematics of upper limb movement (using a KINARM exoskeleton), and (ii) use neuroimaging (MRI and EEG) and neurophysiological
(TMS) measures to determine the characteristics of stroke survivors who are most likely to benefit from this treatment approach. The results from this work will not only determine the effectiveness of a novel technological solution to upper limb impairment after stroke but will help us understand how to incorporate such novel therapies into complex, real-world, multidisciplinary rehabilitation programmes. Also help in identifying patients for future clinical trials of upper limb neurorehabilitation.REC name
Wales REC 2
REC reference
22/WA/0065
Date of REC Opinion
15 Mar 2022
REC opinion
Favourable Opinion