None listed
Conditions
Brief summary
The aim is to determine whether a 3-week programme of high-intensity, high-dose spontaneous exploratory arm and hand movements, focused on movement quality and embedded in fun and rewarding game-based virtual environments, will improve upper limb recovery and outcomes early after stroke. This is a single-site randomised, assessor-blind, controlled Phase IIa clinical trial, that will recruit 140 participants with upper limb impairment within 1 week of stroke. Participants will be randomised to Treatment or Comparison groups (1:1, n = 70 per group), The Treatment group will be given 90 minutes of therapist time per weekday for three weeks to complete high dose arm and hand immersive exploratory therapy. The Comparison group will be given 90 minutes of therapist time per weekday for three weeks to complete conventional upper limb therapy (physiotherapy, occupational therapy). The main hypothesis is that upper limb motor capacity, measured as mean Action Research Arm Test (ARAT) score at 12 weeks post-stroke, will be better for the treatment group than the comparison group.
Interventions
Participants in the intervention group will complete 90 minutes of upper limb therapy each week day, for three weeks, to complete 15 days of therapy. The therapy can be completed in three 30 minute sessions per day, two 45 minute sessions per day, or one 90 minute session per day, depending on patient preference and the clinical judgement of the treating therapist. Therapy will be initiated within 7-14 days of stroke and delivered by a trained and registered therapist (physiotherapy and/or occupational therapy). Therapy will involve the patient interacting with video games provided by the MindPod platform. This is a new therapy approach currently available for research, but not more widely available for routine care. While playing the games participants will control the movement of animals on screen by moving their weaker hand and arm. Patients can play the game either seated or standing, depending on their preference and the clinical judgement of the treating therapist. Sessions will be one-on-one, with one participant interacting with the games under the guidance and supervision of one therapist. For sessions focused on arm movements, patients will control the movements of a dolphin on screen, to make the dolphin swim, jump, catch fish, and avoid sharks. The movements of the patient's upper limb will be video captured, no markers will be attached to the patient. This video information is used in real-time by the MindPod platform to transform the patients’ arm movements into movements of the dolphin. This video information also allows the measurement of the amount of movement and amount of time spent moving by each patient in each session, ,for subsequent reporting. Patients with initially moderate to severe upper limb weakness may be fitted with a vest that provides weight support for the arms, to enable them to engage with the game. The amount of weight support provided by the vest will be adjusted by the treating therapist according to their clinical judgement. The video game will be progressed as the range, speed, and quality of upper limb movement improves over time, by the treating therapist using an interface to adjust the amount of assistance provided by the game. For the hand, patients will rest their hands on a table top device that measures the amount of force produced by each of their fingertips. They will engage in a video game that allows them to control birds on screen by moving their fingers individually. Patients will be seated for this part of the programme, and no upper limb weight support will be necessary. The video game will be progressed as the force and individuation of finger movement improves over time, by the treating therapist using an interface to adjust the amount of assistance provided by the game. The game will record the number of movements and amount of time spent moving during each therapy session for subsequent reporting. For both types of game, the software will record various movement parameters, including distance, time, speed, and accuracy. These characteristics will be subsequently reported. The 90 minutes of therapist time per day can be completed in two 45 minute sessions, or three 30 minute sessions, depending on participant and therapist preferences. The maximum therapist time per week is 450 minutes. The intervention will be considered successfully delivered if the participant completes at least 360 minutes of therapist time in the first week, at least 390 minutes of therapist time in the second week, and at least 420 minutes of therapist time in the third week of the therapy programme.
Sponsors
Study design
Eligibility
Inclusion criteria
i. People with monohemispheric ischaemic stroke or intracerebral haemorrhage confirmed by CT or MRI admitted to Auckland City Hospital within the last 7 days ii. First-ever stroke or previous stroke with no upper limb weakness iii. At least 18 years old iv. Received a “Good” or “Excellent” prediction from the Predict Recovery Potential (PREP2) algorithm v. UE-FM score < 51 at enrolment vi. Able to give informed consent vii. Patients treated with intravenous thrombolysis and/or intra-arterial thrombectomy are eligible
Exclusion criteria
i. UE-FM score > 50 at enrolment ii. Cognition and/or communication impairment precluding informed consent or engagement with the research procedures, as determined by the patient’s clinical team iii. Received a “Limited” or “Poor” PREP2 prediction iv. Inability to sit in a chair and perform upper limb exercises v. Life expectancy less than 12 months, as determined by the patient’s clinical team vi. Upper limb motor performance limited by pre-existing conditions, such as musculoskeletal disease vii. Residing out of region precluding in-person assessment viii. Social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow up assessments