Intensive Upper Limb Training in Chronic Stroke

NCT05527262 | Completed Phase 2 DMC

• 1 other identifier: TBC
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

upper limb; intensive training; motor impairment; kinematics; neurophysiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Fugl Meyer Upper Extremity Assessment

  Baseline and 3 weeks post-intervention

• Action Research Arm Test

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

• Chedoke Arm and Hand Activity Inventory (CAHAI-13)

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

• Stroke Impact Scale

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

• Quality of life (EQ-5D5L)

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

Study Arms (3)

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).

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.

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.

Interventions

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.

Queen Square Upper limb training programme

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.

Mindpod Dolphin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Nick Ward

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39965939 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Nick Ward, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: September 2, 2022
• Study Start: July 4, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after primary publication is complete.
• 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.

Locations

GB (1)