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

• ClinicalTrials.gov Identifier: NCT03425890
• Recruitment Status: Completed
• First Posted: February 8, 2018
• Last Update Posted: September 3, 2019
• Sponsor: Tan Tock Seng Hospital
• Collaborators: National University, Singapore; National University Hospital, Singapore
• Information provided by (Responsible Party): Chin Lay Fong, Tan Tock Seng Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Behavioral: SURE program	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised Blinded Controlled Pilot Trial
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcome assessor will be blinded to which group the participants are in
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 2, 2018
• Actual Primary Completion Date: March 29, 2019
• Actual Study Completion Date: June 20, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: SURE Program Group; 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.	Behavioral: SURE 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
Experimental: Education Group; 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.	Behavioral: SURE 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Singapore

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, Singapore, 569766

Sponsors and Collaborators

Tan Tock Seng Hospital

National University, Singapore

National University Hospital, Singapore

Investigators

• Principal Investigator: Lay Fong Chin, Masters; Tan Tock Seng Hospital

  Study Documents (Full-Text)

Documents provided by Chin Lay Fong, Tan Tock Seng Hospital:

Study Protocol  [PDF] January 22, 2018

More Information

• Responsible Party: Chin Lay Fong, Principal Physiotherapist, Tan Tock Seng Hospital
• ClinicalTrials.gov Identifier: NCT03425890
• Other Study ID Numbers: 2016/00600
• First Posted: February 8, 2018
• Last Update Posted: September 3, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to share individual participants data to other researchers

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chin Lay Fong, Tan Tock Seng Hospital:

Upper Limb; Self-exercise

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases