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

NCT03425890 | Completed

• 1 other identifier: 2016/00600
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Upper Limb; Self-exercise

Outcome Measures

Primary Outcomes (1)

• Change of Upper Limb Fugl Meyer Scale (ULFM)

  Change of Upper Limb Motor Impairment

  Change from pre training to immediate post training

Secondary Outcomes (26)

• Change of Upper Limb Fugl Meyer Scale (ULFM)

  Change from pre training to 2 weeks into training

• Change of Upper Limb Fugl Meyer Scale (ULFM)

  Change from 2 weeks into training to immediate post-training

• Change of Upper Limb Fugl Meyer Scale (ULFM)

  Change from immediate post training to 1-month post-training

• Change of Upper Limb Fugl Meyer Scale (ULFM)

  Change from 1-month post-training to 3 month post-training

• Change of Action Research Arm Test (ARAT)

  Change from pre training to 2 weeks into training

Study Arms (2)

SURE Program Group

EXPERIMENTAL

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

Education Group

EXPERIMENTAL

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

Interventions

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

Education Group; SURE Program Group

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• National University of Singapore: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (1)

Tan Tock Seng Hospital Rehabilitation Centre

Singapore, 569766, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Lay Fong Chin, Masters

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to which group the participants are in
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Physiotherapist

Model Details: Randomised Blinded Controlled Pilot Trial

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 8, 2018
• Study Start: February 2, 2018
• Primary Completion: March 29, 2019
• Study Completion: June 20, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)