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NCT Number: NCT05527262

Intensive Upper Limb Training in Chronic Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nick Ward

London, WC1N 3BG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

Treatment and study plan

Queen Square Upper Limb Neurorehabilitation Programme

Behavioral

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 therapy

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Fugl Meyer Upper Extremity Assessment

    Time frame: Baseline and 3 weeks post-intervention

    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.

  2. Action Research Arm Test

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    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.

  3. Chedoke Arm and Hand Activity Inventory (CAHAI-13)

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    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.

  4. Stroke Impact Scale

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    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.

  5. Quality of life (EQ-5D5L)

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    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.

  6. The stroke self-efficacy questionnaire

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    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

  7. Fugl Meyer Sensory Evaluation

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    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.

  8. Montreal Cognitive Assessment (MOCA)

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    Cognitive impairment measure. The MoCA is scored out of 30 points. A score below 26 may indicate cognitive impairment.

  9. Upper limb strength

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    Dynamometry measure measuring pincer and power grip force.

  10. Electroencephalography

    Time frame: Baseline and 3 weeks post-intervention

    Cortico-cortical connectivity at rest and ascending somatosensory tract integrity evoked potential measures.

  11. Transcranial magnetic stimulation

    Time frame: Baseline and 3 weeks post-intervention

    Corticospinal tract integrity measures involving motor evoked potential recruitment curves of extensor carpi radialis and first dorsal interosseous muscles.

  12. Magnetic Resonance Imaging (3T)

    Time frame: Baseline

    Volumetric structural MRI including full lesion volume.

  13. Kinematic measures- KINARM

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    Kinematic parameter: 2D reaching (assessed using standardised KINARM tasks with scores below 1.96 considered to be within the normal range)

  14. Kinematic measures- KINETIKOS

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    Kinematic parameter: 3D reaching (assessed using standardised KINETIKOS scapulae movement task which measures the amount movement variability of the scapulae during an arm lift).

  15. Finger individuation

    Time frame: Baseline, 3 weeks post-intervention and three-months follow-up

    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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? A Randomised Controlled Trial

Acronym: INTENSIVE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 2, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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