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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: SURE program

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 569766
    • Tan Tock Seng Hospital Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Upper Limb Fugl Meyer Scale (ULFM)	Change of Upper Limb Motor Impairment	Change from pre training to immediate post training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Upper Limb Fugl Meyer Scale (ULFM)	Change of Upper Limb Motor Impairment	Change from pre training to 2 weeks into training
Change of Upper Limb Fugl Meyer Scale (ULFM)	Change of Upper Limb Motor Impairment	Change from 2 weeks into training to immediate post-training
Change of Upper Limb Fugl Meyer Scale (ULFM)	Change of Upper Limb Motor Impairment	Change from immediate post training to 1-month post-training
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
Change of Action Research Arm Test (ARAT)	Change of Upper Limb Functional Outcome	Change from pre training to 2 weeks into training
Change of Action Research Arm Test (ARAT)	Change of Upper Limb Functional Outcome	Change from 2 weeks into training to immediate post training
Change of Action Research Arm Test (ARAT)	Change of Upper Limb Functional Outcome	Change from immediate post training to 1-month post training
Change of Action Research Arm Test (ARAT)	Change of Upper Limb Functional Outcome	Change from 1-month post training to 3-month post training
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Bilateral Motor Cortex Brain Activation	Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI	Measure at pre training
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
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

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: National University Hospital, Singapore; National University, Singapore
• Investigators: Principal Investigator: Lay Fong Chin, Masters, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Upper Limb; Self-exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016/00600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share individual participants data to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No