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Completed

NCT Number: NCT03425890

Effect of Self-empowered Upper Limb Repetitive Engagement (SURE) Program on Upper Limb Recovery After Stroke

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of first-ever stroke occurring less than 21 days ago
  • Positive motor evoked potential on affected hand extensor carpi radialis during Transcranial Magnetic Stimulation (TMS) investigation
  • Clinically moderate to severe UL paresis (ULFM score of less than or equal to 50)
  • Montreal Cognitive Assessment>= 19

Exclusion criteria

  • Prior history of central nervous system disorders e.g. Parkinsonism, Spinal Cord Injury, previous stroke
  • Structural brain lesions e.g. brain tumors
  • Medical history of psychiatric disturbance e.g. schizophrenia
  • Bilateral stroke
  • Cardiac disease that limit function by exertional dyspnoea, angina or severe fatigue (defined by physicians and treating therapists)
  • Hemiplegic shoulder pain VAS >5/10
  • Existing peripheral nerve or orthopaedic conditions that interfere with affected UL movement e.g. frozen shoulder, peripheral nerve damage to UL
  • Severe aphasia, neglect, agitation, or depression (defined by physicians and treating therapists) that can limit participation
  • Any contraindications to MRI and TMS.

Treatment and study plan

SURE program

Behavioral

SURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy

Primary outcomes

  1. Change of Upper Limb Fugl Meyer Scale (ULFM)

    Time frame: Change from pre training to immediate post training

    Change of Upper Limb Motor Impairment

Secondary outcomes

  1. Change of Upper Limb Fugl Meyer Scale (ULFM)

    Time frame: Change from pre training to 2 weeks into training

    Change of Upper Limb Motor Impairment

  2. Change of Upper Limb Fugl Meyer Scale (ULFM)

    Time frame: Change from 2 weeks into training to immediate post-training

    Change of Upper Limb Motor Impairment

  3. Change of Upper Limb Fugl Meyer Scale (ULFM)

    Time frame: Change from immediate post training to 1-month post-training

    Change of Upper Limb Motor Impairment

  4. Change of Upper Limb Fugl Meyer Scale (ULFM)

    Time frame: Change from 1-month post-training to 3 month post-training

    Change of Upper Limb Motor Impairment

  5. Change of Action Research Arm Test (ARAT)

    Time frame: Change from pre training to 2 weeks into training

    Change of Upper Limb Functional Outcome

  6. Change of Action Research Arm Test (ARAT)

    Time frame: Change from 2 weeks into training to immediate post training

    Change of Upper Limb Functional Outcome

  7. Change of Action Research Arm Test (ARAT)

    Time frame: Change from immediate post training to 1-month post training

    Change of Upper Limb Functional Outcome

  8. Change of Action Research Arm Test (ARAT)

    Time frame: Change from 1-month post training to 3-month post training

    Change of Upper Limb Functional Outcome

  9. Rating of Everyday Arm-Use in the Community and Home (REACH)

    Time frame: Measure at 1-month post training

    Measure real-world use of the arm in everyday tasks

  10. Rating of Everyday Arm-Use in the Community and Home (REACH)

    Time frame: Measure at 3-month post training

    Measure real-world use of the arm in everyday tasks

  11. Stanford Fatigue Visual Numeric Scale (FVNS)

    Time frame: 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)

  12. Stanford Fatigue Visual Numeric Scale (FVNS)

    Time frame: Measure at 2 weeks into training

    Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)

  13. Stanford Fatigue Visual Numeric Scale (FVNS)

    Time frame: Measure immediate post training

    Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)

  14. Visual Analogue Scale (VAS)

    Time frame: 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)

  15. Visual Analogue Scale (VAS)

    Time frame: Measure at 2 weeks into training

    Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)

  16. Visual Analogue Scale (VAS)

    Time frame: Measure at immediate post training

    Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)

  17. Modified Ashworth Scale (MAS)

    Time frame: 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)

  18. Modified Ashworth Scale (MAS)

    Time frame: Measure at 2 weeks into training

    Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)

  19. Modified Ashworth Scale (MAS)

    Time frame: Measure at immediate post training

    Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)

  20. Duration of Affected Upper Limb activity in hours

    Time frame: Measure at 1 week into training

    Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer

  21. Duration of Affected Upper Limb activity in hours

    Time frame: Measure at 2 weeks into training

    Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer

  22. Duration of Affected Upper Limb activity in hours

    Time frame: Measure at 3 weeks into training

    Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer

  23. Duration of Affected Upper Limb activity in hours

    Time frame: Measure at 4 weeks 4 into training

    Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer

  24. Bilateral Motor Cortex Brain Activation

    Time frame: Measure at pre training

    Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI

  25. Bilateral Motor Cortex Brain Activation

    Time frame: Measure at immediate post training

    Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI

  26. Bilateral Motor Cortex Brain Activation

    Time frame: Measure at 3-month post training

    Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • National University Hospital, Singapore
  • National University of Singapore

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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