Clinical trial NCT05527262: Intensive Upper Limb Training in Chronic Stroke
Official title: Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke
Keywords: upper limb
intensive training
motor impairment
kinematics
neurophysiology
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fugl Meyer Upper Extremity Assessment
timeFrame: Three-months follow-up
Secondary outcomes:
measure: Fugl Meyer Upper Extremity Assessment
timeFrame: Baseline and 3 weeks post-intervention
measure: Action Research Arm Test
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Chedoke Arm and Hand Activity Inventory (CAHAI-13)
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Stroke Impact Scale
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Quality of life (EQ-5D5L)
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: The stroke self-efficacy questionnaire
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Fugl Meyer Sensory Evaluation
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Upper limb strength
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Electroencephalography
timeFrame: Baseline and 3 weeks post-intervention
measure: Transcranial magnetic stimulation
timeFrame: Baseline and 3 weeks post-intervention
measure: Magnetic Resonance Imaging (3T)
timeFrame: Baseline
measure: Kinematic measures- KINARM
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Kinematic measures- KINETIKOS
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
measure: Finger individuation
timeFrame: Baseline, 3 weeks post-intervention and three-months follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Nick Ward
Study officials:
affiliation: University College, London
name: Nick Ward, MD
role: PRINCIPAL_INVESTIGATOR
References: