CompletedPhase 2

Intensive Upper Limb Training in Chronic Stroke

United Kingdom105 participantsStarted 2022-07-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. Other neurological diagnoses;
✕. Serious communication, cognitive and language deficits (\<7 on shortened version Montreal Cognitive Assessment or \< 34 on Cognitive assessment scale for stroke patients);
✕. Post-stroke frozen shoulder;
✕. Increased muscle tone in wrist/finger extensors (≥3 on Modified Ashworth Scale);
✕. Loss of passive range in any upper limb joints;
✕. Fatigue of \<30 on the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale;

What they're measuring

Fugl Meyer Upper Extremity Assessment

Timeframe: Three-months follow-up

Trial details

NCT IDNCT05527262

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

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