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

NCT ID: NCT03425890

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2019-06-20

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SURE program

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

SURE program

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Singapore

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chin Lay Fong

Principal Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lay Fong Chin, Masters

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2016/00600

Identifier Type: -

Identifier Source: org_study_id