Intensive Upper Limb Training in Chronic Stroke (INTENSIVE)

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).

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 Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Queen Square Upper Limb Neurorehabilitation Programme; Device: Immersive gaming therapy

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • Nick Ward

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: Queen Square Upper Limb Neurorehabilitation Programme; 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.
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.	Device: Immersive gaming therapy; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Baseline, 3 weeks post-intervention and three-months follow-up
Upper limb strength	Dynamometry measure measuring pincer and power grip force.	Baseline, 3 weeks post-intervention and three-months follow-up
Electroencephalography	Cortico-cortical connectivity at rest and ascending somatosensory tract integrity evoked potential measures.	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.	Baseline and 3 weeks post-intervention
Magnetic Resonance Imaging (3T)	Volumetric structural MRI including full lesion volume.	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)	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).	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	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.	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	Baseline, 3 weeks post-intervention and three-months follow-up

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Nick Ward, MD, University College, London

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: upper limb; motor impairment; kinematics; neurophysiology; intensive training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: TBC (TBC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available after primary publication is complete.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No