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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
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 Our unpublished in-service audits suggest that this equates to 45-60 hours of active upper limb training.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.
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.
Nick Ward
London, United Kingdom
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.
Time frame: Three-months follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Upper limb strength
Dynamometry measure measuring pincer and power grip force.
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
Electroencephalography
Cortico-cortical connectivity at rest and ascending somatosensory tract integrity evoked potential measures.
Time frame: 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.
Time frame: Baseline and 3 weeks post-intervention
Magnetic Resonance Imaging (3T)
Volumetric structural MRI including full lesion volume.
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: Baseline, 3 weeks post-intervention and three-months follow-up
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