NCT05527262CompletedPhase 2
Intensive Upper Limb Training in Chronic Stroke
Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? A Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 29 Jun 2022
- Start date
- 4 Jul 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University College, London
- Diseases
- Stroke
- NCT number
- NCT05527262
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 105
- From 4 Jul 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Fatigue of \<30 on the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale;
- Severe shoulder pain measured by Chedoke Impairment Inventory: Stage of Shoulder Pain 1, 2, and 3;
- Vision impairment that impedes seeing the television screen
Other
- Other neurological diagnoses;
- Increased muscle tone in wrist/finger extensors (≥3 on Modified Ashworth Scale);
- Loss of passive range in any upper limb joints;
- Apraxia score of \<5 on the TULIA assessment;
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nick Ward Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.