Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? a Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Phase 2
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 limited. 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 at the level of activity and body function. An alternative way to deliver high doses of effective therapy is through technological developments, e.g. immersive interactive gaming environments such as the MindPod Dolphin programme. The intention of this study is to provide stronger level evidence for intensive upper limb rehabilitation by conducting a randomised controlled trial of two different types of upper limb training compared to usual care. Patients considered suitable for the QSUL programme will be randomised to either: Group 1- intensive upper limb rehabilitation programme (QSUL); Group 2- MindPod programme; Group 3-wait-list control (who will be offered the treatment after the waiting list is complete). The first aim of the study is to compare the effect of each type of high-dose, high-intensity upper limb training to usual care using measures of upper limb impairment and activity levels 3 months after treatment 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 (i) help determine the impact of two methods of high dose, high intensity upper limb training in chronic stroke patients; (ii) identify whether there are any predictors of treatment response that will help stratify patients in future clinical trials of upper limb neurorehabilitation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A first-ever unilateral stroke (ischaemic or haemorrhagic) as defined by WHO at least 6-months previously;

• Moderate upper limb impairment as defined by Fugl-Meyer Upper Extremity (Woodbury et al., 2013) score between 19-46 (to avoid ceiling and floor effects);

• Must be able to voluntarily extend the thumb and/or 2 or more fingers of the affected hand (10° or more)

Locations
Other Locations
United Kingdom
Nick Ward
RECRUITING
London
Contact Information
Primary
Nick Ward, MD
n.ward@ucl.ac.uk
020 3448 8762
Backup
Lisa Tedesco Triccas, PhD
l.triccas@ucl.ac.uk
020 3448 8762
Time Frame
Start Date: 2022-07-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 105
Treatments
Experimental: Queen Square Upper limb training programme
Patients will undergo 45-60 hours of conventional physiotherapy and occupational therapy over 3 weeks as part of the Queen Square Upper Limb Neurorehabilitation Programme (QSUL) (Ward et al., 2019).
Experimental: Mindpod Dolphin
Patients will undergo 45-60 hours of arm, hand and finger training using immersive gaming technology (e.g. MindPod Dolphin) over 3 weeks.
No_intervention: Wait-list Control
Patients will receive no planned treatment but will be on a waiting list for QSUL Programme after their follow up period if over.
Related Therapeutic Areas
Sponsors
Leads: University College, London

This content was sourced from clinicaltrials.gov