Intensive Upper Limb Training in Chronic Stroke

Stroke Clinical Trial

— INTENSIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527262
• Other study ID #: TBC
• Status: Recruiting
• Phase: Phase 2
• Start date: July 4, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2022
• Source: University College, London
• Contact: Nick Ward, MD
• Phone: 020 3448 8762
• Email: n.ward[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

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.

Locations

Country	Name	City	State
United Kingdom	Nick Ward	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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