Intensive upper limb training for chronic stroke survivors
Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? a Randomised Controlled Trial
This study is testing two different intensive upper limb rehab programs for people who have had a stroke to see if they can help improve movement and daily activities better than regular care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05527262 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two types of intensive upper limb rehabilitation programs for chronic stroke survivors, comparing them to usual care. Participants will receive either the Queen Square Upper Limb Neurorehabilitation Programme or immersive gaming therapy over a period of three weeks, totaling 90 hours of treatment. The goal is to provide stronger evidence for high-dose neurorehabilitation and assess improvements in motor function and activity levels. The study will involve randomization to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced a first-ever unilateral stroke at least six months prior and have moderate upper limb impairment.
Not a fit: Patients with other neurological conditions, severe cognitive deficits, or significant shoulder pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve motor function and quality of life for chronic stroke survivors.
How similar studies have performed: Previous studies have shown promising results with high-intensity rehabilitation approaches, making this a potentially impactful continuation of that research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A first-ever unilateral stroke (ischaemic or haemorrhagic) as defined by WHO at least 6-months previously; 2. 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); 3. Must be able to voluntarily extend the thumb and/or 2 or more fingers of the affected hand (10° or more) Exclusion Criteria: 1. Other neurological diagnoses; 2. Serious communication, cognitive and language deficits (\<7 on shortened version Montreal Cognitive Assessment or \< 34 on Cognitive assessment scale for stroke patients); 3. Post-stroke frozen shoulder; 4. Increased muscle tone in wrist/finger extensors (≥3 on Modified Ashworth Scale); 5. Loss of passive range in any upper limb joints; 6. Fatigue of \<30 on the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale; 7. Apraxia score of \<5 on the TULIA assessment; 8. Severe shoulder pain measured by Chedoke Impairment Inventory: Stage of Shoulder Pain 1, 2, and 3; 9. Vision impairment that impedes seeing the television screen
Where this trial is running
London
- Nick Ward — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nick Ward, MD — University College, London
- Study coordinator: Nick Ward, MD
- Email: n.ward@ucl.ac.uk
- Phone: 020 3448 8762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.