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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
SURE program
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Upper Limb, Self-exercise

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tan Tock Seng Hospital Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SURE Program Group

Education Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment

Secondary Outcome Measures

Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Rating of Everyday Arm-Use in the Community and Home (REACH)
Measure real-world use of the arm in everyday tasks
Rating of Everyday Arm-Use in the Community and Home (REACH)
Measure real-world use of the arm in everyday tasks
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)
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)
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)
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)
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)
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)
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)
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)
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)
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Bilateral Motor Cortex Brain Activation
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Bilateral Motor Cortex Brain Activation
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Bilateral Motor Cortex Brain Activation
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI

Full Information

First Posted
January 25, 2018
Last Updated
August 30, 2019
Sponsor
Tan Tock Seng Hospital
Collaborators
National University of Singapore, National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03425890
Brief Title
Effect of Self-empowered Upper Limb Repetitive Engagement (SURE) Program on Upper Limb Recovery After Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
National University of Singapore, National University Hospital, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper Limb, Self-exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Blinded Controlled Pilot Trial
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to which group the participants are in
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SURE Program Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SURE program
Intervention Description
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 Outcome Measure Information:
Title
Change of Upper Limb Fugl Meyer Scale (ULFM)
Description
Change of Upper Limb Motor Impairment
Time Frame
Change from pre training to immediate post training
Secondary Outcome Measure Information:
Title
Change of Upper Limb Fugl Meyer Scale (ULFM)
Description
Change of Upper Limb Motor Impairment
Time Frame
Change from pre training to 2 weeks into training
Title
Change of Upper Limb Fugl Meyer Scale (ULFM)
Description
Change of Upper Limb Motor Impairment
Time Frame
Change from 2 weeks into training to immediate post-training
Title
Change of Upper Limb Fugl Meyer Scale (ULFM)
Description
Change of Upper Limb Motor Impairment
Time Frame
Change from immediate post training to 1-month post-training
Title
Change of Upper Limb Fugl Meyer Scale (ULFM)
Description
Change of Upper Limb Motor Impairment
Time Frame
Change from 1-month post-training to 3 month post-training
Title
Change of Action Research Arm Test (ARAT)
Description
Change of Upper Limb Functional Outcome
Time Frame
Change from pre training to 2 weeks into training
Title
Change of Action Research Arm Test (ARAT)
Description
Change of Upper Limb Functional Outcome
Time Frame
Change from 2 weeks into training to immediate post training
Title
Change of Action Research Arm Test (ARAT)
Description
Change of Upper Limb Functional Outcome
Time Frame
Change from immediate post training to 1-month post training
Title
Change of Action Research Arm Test (ARAT)
Description
Change of Upper Limb Functional Outcome
Time Frame
Change from 1-month post training to 3-month post training
Title
Rating of Everyday Arm-Use in the Community and Home (REACH)
Description
Measure real-world use of the arm in everyday tasks
Time Frame
Measure at 1-month post training
Title
Rating of Everyday Arm-Use in the Community and Home (REACH)
Description
Measure real-world use of the arm in everyday tasks
Time Frame
Measure at 3-month post training
Title
Stanford Fatigue Visual Numeric Scale (FVNS)
Description
Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)
Time Frame
Measure at pre training
Title
Stanford Fatigue Visual Numeric Scale (FVNS)
Description
Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)
Time Frame
Measure at 2 weeks into training
Title
Stanford Fatigue Visual Numeric Scale (FVNS)
Description
Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)
Time Frame
Measure immediate post training
Title
Visual Analogue Scale (VAS)
Description
Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)
Time Frame
Measure at pre training
Title
Visual Analogue Scale (VAS)
Description
Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)
Time Frame
Measure at 2 weeks into training
Title
Visual Analogue Scale (VAS)
Description
Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)
Time Frame
Measure at immediate post training
Title
Modified Ashworth Scale (MAS)
Description
Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)
Time Frame
Measure at pre training
Title
Modified Ashworth Scale (MAS)
Description
Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)
Time Frame
Measure at 2 weeks into training
Title
Modified Ashworth Scale (MAS)
Description
Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)
Time Frame
Measure at immediate post training
Title
Duration of Affected Upper Limb activity in hours
Description
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Time Frame
Measure at 1 week into training
Title
Duration of Affected Upper Limb activity in hours
Description
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Time Frame
Measure at 2 weeks into training
Title
Duration of Affected Upper Limb activity in hours
Description
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Time Frame
Measure at 3 weeks into training
Title
Duration of Affected Upper Limb activity in hours
Description
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Time Frame
Measure at 4 weeks 4 into training
Title
Bilateral Motor Cortex Brain Activation
Description
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Time Frame
Measure at pre training
Title
Bilateral Motor Cortex Brain Activation
Description
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Time Frame
Measure at immediate post training
Title
Bilateral Motor Cortex Brain Activation
Description
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Time Frame
Measure at 3-month post training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lay Fong Chin, Masters
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital Rehabilitation Centre
City
Singapore
ZIP/Postal Code
569766
Country
Singapore

12. IPD Sharing Statement

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

Learn more about this trial

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

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