StrokePhase 2INTENSIVENCT05527262
Intensive Upper Limb Training in Chronic Stroke
A Phase 2 study testing Queen Square Upper Limb Neurorehabilitation Programme and Immersive gaming therapy in people with Stroke, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Queen Square Upper Limb Neurorehabilitation Programme and Immersive gaming therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 9Show fewer
- Apraxia score of <5 on the TULIA assessment;
- Severe shoulder pain measured by Chedoke Impairment Inventory: Stage of Shoulder Pain 1, 2, and 3;
- Vision impairment that impedes seeing the television screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? A Randomised Controlled Trial
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).
Read more
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.
- Conditions
- Stroke
- Being tested
- Queen Square Upper Limb Neurorehabilitation Programme, Immersive gaming therapy
- Keywords
- upper limb, intensive training, motor impairment, kinematics, neurophysiology
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Queen Square Upper Limb Neurorehabilitation ProgrammeBehavioural
A timetable will be implemented including a minimum of 45 hours of active time on task over 3 weeks 5-days a week (first and last day will involve the assessment procedures) (timetabled, 90-hours). Our unpublished in-service audits suggest that this equates to 45-60 hours of active upper limb training. The remainder of the time is spent on rest (in-session, between-session), cardiovascular fitness, and education (promoting self-efficacy). The programme is staffed with a 1:1 staff/patient ratio (4 physiotherapists, 4 occupational therapists, 4 rehabilitation assistants for 12 patients at any one time). Participants in this trial will receive two daily sessions each of physiotherapy and occupational therapy, supplemented with tailored, individualised interventions delivered by rehabilitation assistants either singly or in groups.
Immersive gaming therapyDevice
The treatment group will receive a minimum of 45 hours of active time on task over 3 weeks, 5 days a week (first and last day will involve the assessment procedures) to complete arm, hand and finger training (overseen by a physiotherapist). Patients will engage with MindPod Dolphin (shoulder/elbow) and other interfaces (hand/fingers) in a customised immersive game-based platform set.
| Study group | Role | What they receive |
|---|---|---|
| Queen Square Upper limb training programme | Experimental | 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). Receives: Behavioral: Queen Square Upper Limb Neurorehabilitation Programme |
| Mindpod Dolphin | Experimental | Patients will undergo 45-60 hours of arm, hand and finger training using immersive gaming technology (e.g. MindPod Dolphin) over 3 weeks. Receives: Device: Immersive gaming therapy |
| Wait-list Control | No intervention | Patients will receive no planned treatment but will be on a waiting list for QSUL Programme after their follow up period if over. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Upper Extremity Assessment
Upper limb motor impairment measure, with a minimum score of 0 and a maximum score of 60 (excluding reflexes, Woodbury et al., 2007). A higher score means a better upper limb motor impairment outcome.
Measured: Three-months follow-up
Secondary outcomes (15)
Fugl Meyer Upper Extremity Assessment
Upper limb motor impairment measure, with a minimum score of 0 and a maximum score of 60 (excluding reflexes, Woodbury et al., 2007). A higher score means a better upper limb motor impairment outcome.
Measured: Baseline and 3 weeks post-intervention
Action Research Arm Test
Upper limb function and dexterity measure with a minimum score of 0 and a maximum score of 57. A higher score means a better upper limb function and dexterity outcome.
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Chedoke Arm and Hand Activity Inventory (CAHAI-13)
Upper limb function measure with a minimum score of 13 and maximum score of 91. A higher score indicating a better upper limb function outcome.
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Stroke Impact Scale
Disability and quality of life measure with a minimum score of 0 and a maximum score of 100. A higher score indicating a higher quality of life.
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Quality of life (EQ-5D5L)
Quality of Life measure with a minimum score of 1,1,1,1,5 and a maximum score of 5,5,5,5,5. A higher score means more severe and frequent problems.
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
The stroke self-efficacy questionnaire
Self-efficacy measure involving 3-item self-report scale measuring self-efficacy judge- ments in specific domains of functioning post stroke. Individuals rate their belief in their ability to achieve each of the 13 items on a 10-point scale, where 0 = not at all confident to 10 = very confident
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Fugl Meyer Sensory Evaluation
Upper limb sensory function measure with a minimum score of 0 and a maximum score of 12 per domain. A higher score indicates a better somatosensory outcome.
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Montreal Cognitive Assessment (MOCA)
Cognitive impairment measure. The MoCA is scored out of 30 points. A score below 26 may indicate cognitive impairment.
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Upper limb strength
Dynamometry measure measuring pincer and power grip force.
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Electroencephalography
Cortico-cortical connectivity at rest and ascending somatosensory tract integrity evoked potential measures.
Measured: Baseline and 3 weeks post-intervention
Transcranial magnetic stimulation
Corticospinal tract integrity measures involving motor evoked potential recruitment curves of extensor carpi radialis and first dorsal interosseous muscles.
Measured: Baseline and 3 weeks post-intervention
Magnetic Resonance Imaging (3T)
Volumetric structural MRI including full lesion volume.
Measured: Baseline
Kinematic measures- KINARM
Kinematic parameter: 2D reaching (assessed using standardised KINARM tasks with scores below 1.96 considered to be within the normal range)
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Kinematic measures- KINETIKOS
Kinematic parameter: 3D reaching (assessed using standardised KINETIKOS scapulae movement task which measures the amount movement variability of the scapulae during an arm lift).
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Finger individuation
The ability to move fingers independently will be assessed using a customised task and an ergonomic device (Hummingbird, Mindmaze) that will independently measure finger strength and dexterity from all digits, in both flexion and extension movements. The device will obtain maximum voluntary force for each finger, and finger individuation, by measuring how much the non-instructed fingers participate when only one instructed finger needs to be moved independently
Measured: Baseline, 3 weeks post-intervention and three-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start4 Jul 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Ward, MD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527262
- Sponsor's protocol ID
- TBC
- Acronym
- INTENSIVE
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the study, access to anonymised data will be strongly regulated and permissions to access the data will be treated on a case-by-case basis.
Publications
Tedesco Triccas L, Sporn S, Coll I Omana M, Brander F, Kelly K, Bestmann S, Ward N. High-dose high-intensity Queen Square upper-limb rehabilitation for people with chronic stroke (INTENSIVE): protocol for a single-centre, randomised controlled trial. BMJ Open. 2025 Feb 18;15(2):e095766. doi: 10.1136/bmjopen-2024-095766.
PubMed 39965939
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05527262
- Acronym / sponsor ID
- INTENSIVE / TBC
- Conditions
- Stroke
- Keywords
- upper limb, intensive training, motor impairment, kinematics, neurophysiology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Queen Square Upper limb training programme | Experimental | Behavioral: Queen Square Upper Limb Neurorehabilitation ProgrammePatients 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). |
| Mindpod Dolphin | Experimental | Device: Immersive gaming therapyPatients will undergo 45-60 hours of arm, hand and finger training using immersive gaming technology (e.g. MindPod Dolphin) over 3 weeks. |
| Wait-list Control | No intervention | –Patients will receive no planned treatment but will be on a waiting list for QSUL Programme after their follow up period if over. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Queen Square Upper Limb Neurorehabilitation ProgrammeA timetable will be implemented including a minimum of 45 hours of active time on task over 3 weeks 5-days a week (first and last day will involve the assessment procedures) (timetabled, 90-hours). Our unpublished in-service audits suggest that this equates to 45-60 hours of active upper limb training. The remainder of the time is spent on rest (in-session, between-session), cardiovascular fitness, and education (promoting self-efficacy). The programme is staffed with a 1:1 staff/patient ratio (4 physiotherapists, 4 occupational therapists, 4 rehabilitation assistants for 12 patients at any one time). Participants in this trial will receive two daily sessions each of physiotherapy and occupational therapy, supplemented with tailored, individualised interventions delivered by rehabilitation assistants either singly or in groups. | Behavioural | Queen Square Upper limb training programme |
| Immersive gaming therapyThe treatment group will receive a minimum of 45 hours of active time on task over 3 weeks, 5 days a week (first and last day will involve the assessment procedures) to complete arm, hand and finger training (overseen by a physiotherapist). Patients will engage with MindPod Dolphin (shoulder/elbow) and other interfaces (hand/fingers) in a customised immersive game-based platform set. | Device | Mindpod Dolphin |
Primary outcome
Fugl Meyer Upper Extremity Assessment
Time frame: Three-months follow-up
Upper limb motor impairment measure, with a minimum score of 0 and a maximum score of 60 (excluding reflexes, Woodbury et al., 2007). A higher score means a better upper limb motor impairment outcome.
15 secondary outcomes
Fugl Meyer Upper Extremity Assessment
Time frame: Baseline and 3 weeks post-intervention
Action Research Arm Test
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Chedoke Arm and Hand Activity Inventory (CAHAI-13)
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Stroke Impact Scale
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Quality of life (EQ-5D5L)
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
The stroke self-efficacy questionnaire
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Fugl Meyer Sensory Evaluation
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Montreal Cognitive Assessment (MOCA)
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Upper limb strength
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Electroencephalography
Time frame: Baseline and 3 weeks post-intervention
Transcranial magnetic stimulation
Time frame: Baseline and 3 weeks post-intervention
Magnetic Resonance Imaging (3T)
Time frame: Baseline
Kinematic measures- KINARM
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Kinematic measures- KINETIKOS
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Finger individuation
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 39965939Tedesco Triccas L, Sporn S, Coll I Omana M, Brander F, Kelly K, Bestmann S, Ward N. High-dose high-intensity Queen Square upper-limb rehabilitation for people with chronic stroke (INTENSIVE): protocol for a single-centre, randomised controlled trial. BMJ Open. 2025 Feb 18;15(2):e095766. doi: 10.1136/bmjopen-2024-095766.
- Individual participant dataSharing planned: Yes. Following the study, access to anonymised data will be strongly regulated and permissions to access the data will be treated on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Ward, MD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Queen Square Upper Limb Neurorehabilitation Programme and Immersive gaming therapy in people with Stroke, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Upper Extremity Assessment (time frame: Three-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.