Intensive Upper Limb Training in Chronic Stroke (INTENSIVE)

University College London (UCL)

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Device: Immersive gaming therapy; Behavioral: Queen Square Upper Limb Neurorehabilitation Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT05527262

TBC

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

Queen Square Upper limb training programme

Experimental group

Description:

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).

Treatment:

Behavioral: Queen Square Upper Limb Neurorehabilitation Programme

Mindpod Dolphin

Experimental group

Description:

Patients will undergo 45-60 hours of arm, hand and finger training using immersive gaming technology (e.g. MindPod Dolphin) over 3 weeks.

Treatment:

Device: Immersive gaming therapy

Wait-list Control

No Intervention group

Description:

Patients will receive no planned treatment but will be on a waiting list for QSUL Programme after their follow up period if over.