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

NCT02073773 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-02-10

No results posted yet for this study

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

Conditions

  • Ischaemic Stroke

Interventions

DRUG

Levodopa

Levodopa 100mg with benserazide 25mg will be administered 3 hours prior to the start of the daily PT/OT session to maximize its pharmacokinetic window ie. blood plasma levels in the narrow window during which functional rewiring of neural circuits is thought to occur. Levodopa at the lowest available dose (100mg P.O qd) has been shown to improve motor function of stroke patients and their corresponding quality of life. The treatment proposed can be incorporated into their daily rehabilitation routine. Early intervention (within 7-21 days of the infarct) raises the chance for neuroplasticity and improved recovery of their motor function in the short and long run. Levodopa has been proven to be safe to be used in stroke patients (Lancet. 2001 Sep 8;358(9284):787-90., Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41.), however, the side effects of this medication may include nausea, unusual tiredness, dizziness, excessive watering of mouth.

OTHER

Virtual Reality based therapy

The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.

Sponsors & Collaborators

  • Singapore University of Technology and Design

    collaborator UNKNOWN

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Yee S NG, MBBS, MRCP · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Singapore

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073773 on ClinicalTrials.gov