Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The present proposal aims to assess whether a combined rehabilitation approach using virtual reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard rehabilitative occupational therapy and physiotherapy will lead to signifcantly better outcomes for stroke recovery.

It is a randomised controlled trial with blinding of the assessors only. It will be preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only. Recruited in-patient rehabilitation ward patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:

1. Control occupational therapy + pharmacotherapy for 2 weeks

2. Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborators: Hutcabb Consultancy Pte Ltd; Singapore University of Technology and Design
• Treatments: Benserazide; Levodopa

Criteria

Inclusion Criteria:

• Age: 25-99yrs

• Right-handed

• Cognitively coherent, able to provide informed consent (MMSE >25)

• Newly diagnosed, first episode ischemic stroke in the past 2-21 days

• Motor score: Strength of 2-3 out of 5 on affected side upper limb

Exclusion Criteria:

• Declined consent to participate in the study

• Cognitive impairment or significant aphasia with inability to understand study requirements and inability to participate in therapy

• Other neurological or physical ailments with pre-existing motor weakness

• Haemorrhagic stroke

• Patient due to undergo significant medical interventions such as carotid endarthrectomy

• Patients on neuroactive agents prior to the stroke such as antidepressants

• Hypersensitivity to benserazide, levodopa, sympathomimetics, or any component of the formulation

• Use of MAO inhibitors within the last 14 days

• Patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, renal, hepatic, hematologic, or pulmonary disease

• Patients with decompensated endocrine, renal, hepatic, cardiac disorders, psychiatric disorders, narrow-angle glaucoma, or closed-angle glaucoma;

• Patients <25 years of age (due to possibility of skeletal abnormalities from benserazide)

• Pregnancy or use in women of childbearing potential without adequate contraception.