Stroke Clinical Trial
Official title:
The Effect of the Self-empowered Upper Limb Repetitive Engagement (SURE) Program on Upper Limb Recovery Compared With Education in People With Stroke Undergoing Inpatient Rehabilitation
Verified date | August 2019 |
Source | Tan Tock Seng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 20, 2019 |
Est. primary completion date | March 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Tan Tock Seng Hospital Rehabilitation Centre | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital | National University Hospital, Singapore, National University, Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Upper Limb Fugl Meyer Scale (ULFM) | Change of Upper Limb Motor Impairment | Change from pre training to immediate post training | |
Secondary | Change of Upper Limb Fugl Meyer Scale (ULFM) | Change of Upper Limb Motor Impairment | Change from pre training to 2 weeks into training | |
Secondary | Change of Upper Limb Fugl Meyer Scale (ULFM) | Change of Upper Limb Motor Impairment | Change from 2 weeks into training to immediate post-training | |
Secondary | Change of Upper Limb Fugl Meyer Scale (ULFM) | Change of Upper Limb Motor Impairment | Change from immediate post training to 1-month post-training | |
Secondary | Change of Upper Limb Fugl Meyer Scale (ULFM) | Change of Upper Limb Motor Impairment | Change from 1-month post-training to 3 month post-training | |
Secondary | Change of Action Research Arm Test (ARAT) | Change of Upper Limb Functional Outcome | Change from pre training to 2 weeks into training | |
Secondary | Change of Action Research Arm Test (ARAT) | Change of Upper Limb Functional Outcome | Change from 2 weeks into training to immediate post training | |
Secondary | Change of Action Research Arm Test (ARAT) | Change of Upper Limb Functional Outcome | Change from immediate post training to 1-month post training | |
Secondary | Change of Action Research Arm Test (ARAT) | Change of Upper Limb Functional Outcome | Change from 1-month post training to 3-month post training | |
Secondary | Rating of Everyday Arm-Use in the Community and Home (REACH) | Measure real-world use of the arm in everyday tasks | Measure at 1-month post training | |
Secondary | Rating of Everyday Arm-Use in the Community and Home (REACH) | Measure real-world use of the arm in everyday tasks | Measure at 3-month post training | |
Secondary | Stanford Fatigue Visual Numeric Scale (FVNS) | Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience) | Measure at pre training | |
Secondary | Stanford Fatigue Visual Numeric Scale (FVNS) | Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience) | Measure at 2 weeks into training | |
Secondary | Stanford Fatigue Visual Numeric Scale (FVNS) | Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience) | Measure immediate post training | |
Secondary | Visual Analogue Scale (VAS) | Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience) | Measure at pre training | |
Secondary | Visual Analogue Scale (VAS) | Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience) | Measure at 2 weeks into training | |
Secondary | Visual Analogue Scale (VAS) | Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience) | Measure at immediate post training | |
Secondary | Modified Ashworth Scale (MAS) | Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone) | Measure at pre training | |
Secondary | Modified Ashworth Scale (MAS) | Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone) | Measure at 2 weeks into training | |
Secondary | Modified Ashworth Scale (MAS) | Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone) | Measure at immediate post training | |
Secondary | Duration of Affected Upper Limb activity in hours | Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer | Measure at 1 week into training | |
Secondary | Duration of Affected Upper Limb activity in hours | Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer | Measure at 2 weeks into training | |
Secondary | Duration of Affected Upper Limb activity in hours | Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer | Measure at 3 weeks into training | |
Secondary | Duration of Affected Upper Limb activity in hours | Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer | Measure at 4 weeks 4 into training | |
Secondary | Bilateral Motor Cortex Brain Activation | Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI | Measure at pre training | |
Secondary | Bilateral Motor Cortex Brain Activation | Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI | Measure at immediate post training | |
Secondary | Bilateral Motor Cortex Brain Activation | Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI | Measure at 3-month post training |
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