None listed
Conditions
Brief summary
This study aims to improve recovery for stroke survivors with arm and hand movement difficulties. Currently, therapists lack clear guidance on the best treatment approach, and what to do when an initial treatment isn't working. This research addresses this gap by using a new strategy that personalises treatment based on a patient's progress. Participants will be screened for eligibility and then randomly assigned to one of three therapies: robotics training, electrical stimulation, or task-specific exercises. A key part of the study involves reassessing participants after three weeks. If they haven't shown improvement, they will be reassigned to a different therapy for another three weeks. To track progress and identify who benefits most, upper limb function will be measured at the start, at three weeks, and at the end of the six-week trial. Additionally, biological markers, such as brain scans and saliva samples, will be analysed to help predict which patients are most likely to respond to a particular treatment.
Interventions
This study aims to improve stroke recovery for survivors who have difficulty moving their arms and/or hands. Individuals with moderate-to-severe upper limb deficits after stroke often don't regain full function and therapists lack clear guidance on which treatments should be prescribes when, and what to do when the prescribed treatment doesn't work. This study employs a new approach that tailors treatment based on a client's progress after 4 weeks.
Participants will be randomly assigned to one
This study aims to improve stroke recovery for survivors who have difficulty moving their arms and/or hands. Individuals with moderate-to-severe upper limb deficits after stroke often don't regain full function and therapists lack clear guidance on which treatments should be prescribes when, and what to do when the prescribed treatment doesn't work. This study employs a new approach that tailors treatment based on a client's progress after 4 weeks. Participants will be randomly assigned to one of three effective therapies (all of which are recommended in the current stroke guidelines). Therapies will be delivered one-on-one and face-to-face: A. Task-specific motor training involves practising context-specific motor tasks (part-practice and whole of task practice) alongside receiving feedback from the therapist to focus on improving performance in real-life movements and tasks using the affected upper limb. Tasks will be adapted to suit the participant's abilities and their goals; example exercises include practicing wrist extension control in pronation (part-practice), followed by practice integrating this wrist extension control in a mid-prone plane during reach towards a cup (i.e. grasp and release). B. Electrical stimulation uses small electrical currents to activate muscles and assist movement during arm exercises, helping to improve strength and control. The stimulation parameters will be tailored to each individual participant at a frequency of between 50-70Hz, 200-300µs pulse, and an on/off cycle of 15s on/15s off to activate the muscles for high repetitions. C. Repetitive, gamified motor training uses a skateboard to remove friction in movement, and computer to encourage active arm and hand movement attempts. An example of the exercise includes controlling the cursor during a video game by extending the wrist to hit a button mounted on the skateboard. Strategies to monitor adherence in the intervention include counting repetitions and minutes of time on task using a session log; one session per week will be video recorded to allow detailed recordings of the exercises and motor performance. Participants will undergo an upper limb assessment after 3 weeks of treatment to determine if the initial treatment is effective for them, and if not, they will be re-randomised into a new treatment for a further 3 weeks. Treatment is delivered for 2 hours per day, 5 days a week for the 6-week study duration. Treatment will be tailored and supported by a qualified occupational therapist or physiotherapist in a treatment room or in the participants’ hospital room. All therapists will be AHPRA-registered and trained in the study protocols. If participants are discharge to their home, the therapist will travel to their home or an outpatient clinic space to continue their therapy until the end of trial at 6 weeks. To assess client improvement, upper limb assessments will be conducted at baseline (0 weeks), mid-point (3 weeks), and end of trial (6 weeks). Biological markers (incl. brain scans, saliva samples) will also be collected. A nested qualitative study will be conducted with participants at the completion of the consent discussion, to better understand how to explain sequential randomisation (our design) to people with stroke and their responsible others. Importantly, researchers do not know if providing a video will aid this understanding in addition to the standard consent process. Therefore it is proposed to seeking consent using one of two pathways (standard and video-enabled) and seeking feedback at that point (before offering the opportunity for the standard pathway consent recipients to watch the video explanation). The two consent pathways will be offered to both stroke patients with capacity to consent and Responsible Persons. The video used in the consent pathway will contain information comparable to that in the PICF, presented in clear, accessible language. Both cover the study purpose, procedures, risks, benefits, and withdrawal rights, ensuring both pathways provide comprehensive information to support informed decision-making.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria include: -Aged 18 years or over. -A diagnosis of first stroke event (haemorrhagic or ischaemic). -Functional upper limb impairment as indicated by a score of 6 or below on the Box and Block test. -Suitability for upper limb rehabilitation as confirmed by the presence of voluntary finger extension (VFE) in at least 2 out of 5 digits. -Sufficient comprehension to participate, which is defined by a score 4 or fewer errors on the Short Portable Mental Status Questionnaire (SPMSQ) and less than 6 on the Language Screening Test (LAST)
Exclusion criteria
Exclusion criteria include: -People with mild upper limb impairment as indicated by a score above 6 on the Box and Block test. -Non-stroke related upper limb impairment to stroke affected arm that prevents participation in motor training (e.g. frozen shoulder, arthritis, fracture). -Patients with contraindications to specific components of the study (e.g. MRI) may still be able to participate in the remainder of the study components if it is safe to do so. However, they will be excluded from components deemed to be unsafe by their treating clinical team. However, patients with contraindications to any of the treatments (e.g. a medical doctor deems a patient with a pacemaker is not fit for electrical stimulation) will be excluded from the study, as they will be unable to meaningfully participate in the treatment.
Outcome results
None listed