Stroke
Conditions
Keywords
Upper Limb, Self-exercise
Brief summary
The aim of this study is to investigate the effect of SURE program on UL recovery during first few weeks post-stroke. A randomised blinded controlled pilot trial will be conducted. Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education program. This is to perform on top of their usual care. To determine the clinical benefit, all participants will be assessed pre-, 2 weeks during the training, post-training, 1-month and 3-month follow-up using a range of impairment and activity measures. To determine the cortical activation (fMRI), structural (FLAIR and DTI) and functional (resting state fcMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre-, post- and post-3 months after training.
Detailed description
Background: UL recovery after stroke has been found to be limited. Efforts should be channelled into rehabilitation to improve UL recovery after stroke. First 4-weeks post-stroke is the period when neuroplasticity unfolds and when most rehabilitation occurs. This critical time window should be capitalized to interact with spontaneous biological recovery to facilitate UL recovery. There is growing evidence that shows that early increased UL practice after stroke improves the recovery of upper limb function. However, it has also been found that the level of early UL practice and use during early post-stroke is low. SURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy. Aim: To investigate the effect of SURE program on UL recovery during first few weeks post-stroke. Method: A randomised blinded controlled pilot trial will be conducted. Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education program. Intervention Group- SURE Program The intervention group will receive a SURE program booklet and will perform individualized daily self-exercise and functional use of the arm and hand on their own outside of therapy for 60 minutes/day, 6 days/week for 4 weeks. These self-exercises and upper limb functional use will be performed in addition to usual care. Three SURE program booklets have been developed which relate to the affected upper limb motor capability using individual Fugl Meyer (ULFM) score. Each SURE program booklet consists of warm-up exercises, strengthening exercises and motor tasks. The SURE program booklet also includes selected functional motor tasks to be performed by the participants using their affected upper limb. The performance of the exercises and functional motor tasks will be reviewed three times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period. Control Group- Education The control group will receive an education booklet with 10 modules. The education booklet will contain information on stroke, recovery and management strategies after stroke. Participants are to complete 2-3 modules per week and answer 1-2 simple questions after each module. Each module including answering questions takes approximately 5-10 minutes to complete. CPI will review the information with the participants 3 times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period.The participants in the control group will continue with their usual care in the hospital. To determine the clinical benefit, all participants will be assessed pre-, 2 weeks during the training, post-training, 1-month and 3-month follow-up using a range of impairment and activity measures. To determine the cortical activation (fMRI), structural (FLAIR and DTI) and functional (resting state fcMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre-, post- and post-3 months after training.
Interventions
BEHAVIORALSURE program
SURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy
Sponsors
National University of Singapore
National University Hospital, Singapore
Tan Tock Seng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded to which group the participants are in
Intervention model description
Randomised Blinded Controlled Pilot Trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of first-ever stroke occurring less than 21 days ago 2. Positive motor evoked potential on affected hand extensor carpi radialis during Transcranial Magnetic Stimulation (TMS) investigation 3. Clinically moderate to severe UL paresis (ULFM score of less than or equal to 50) 4. Montreal Cognitive Assessment\>= 19
Exclusion criteria
1. Prior history of central nervous system disorders e.g. Parkinsonism, Spinal Cord Injury, previous stroke 2. Structural brain lesions e.g. brain tumors 3. Medical history of psychiatric disturbance e.g. schizophrenia 4. Bilateral stroke 5. Cardiac disease that limit function by exertional dyspnoea, angina or severe fatigue (defined by physicians and treating therapists) 6. Hemiplegic shoulder pain VAS \>5/10 7. Existing peripheral nerve or orthopaedic conditions that interfere with affected UL movement e.g. frozen shoulder, peripheral nerve damage to UL 8. Severe aphasia, neglect, agitation, or depression (defined by physicians and treating therapists) that can limit participation 9. Any contraindications to MRI and TMS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Upper Limb Fugl Meyer Scale (ULFM) | Change from pre training to immediate post training | Change of Upper Limb Motor Impairment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Action Research Arm Test (ARAT) | Change from pre training to 2 weeks into training | Change of Upper Limb Functional Outcome |
| Rating of Everyday Arm-Use in the Community and Home (REACH) | Measure at 1-month post training | Measure real-world use of the arm in everyday tasks |
| Stanford Fatigue Visual Numeric Scale (FVNS) | Measure at pre training | Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience) |
| Change of Upper Limb Fugl Meyer Scale (ULFM) | Change from pre training to 2 weeks into training | Change of Upper Limb Motor Impairment |
| Modified Ashworth Scale (MAS) | Measure at pre training | Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone) |
| Duration of Affected Upper Limb activity in hours | Measure at 1 week into training | Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer |
| Bilateral Motor Cortex Brain Activation | Measure at pre training | Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI |
| Visual Analogue Scale (VAS) | Measure at pre training | Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience) |
Countries
Singapore
Outcome results
None listed