Hybrid Approach to Unilateral vs. Bilateral Upper Limb Rehabilitation in Subacute and Chronic Stroke

Cerebrovascular Accident Clinical Trial

Official title: Hybrid Approach to Unilateral vs. Bilateral Upper Limb Rehabilitation in Subacute and Chronic Stroke

Status Withdrawn

Clinical Trial Summary

In the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate clinical trials: one to recruit subacute stroke patients and another to recruit chronic stroke patients. The two trials will have identical study designs and interventions. The overall goal of this research project is to provide scientific evidence of the treatment effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients and thus to contribute to evidence-based stroke rehabilitation and translational research for neurorehabilitation.

Clinical Trial Description

The first aim of the project will be to compare treatment effects between hybrid rehabilitation and conventional rehabilitations (CR) on motor function, daily functions, mobility, quality of life, and kinematic variables. We hypothesize that patients receiving hybrid rehabilitation will gain more recovery than patients receiving CR in proximal (e.g., motor function) and in distal outcomes (e.g., quality of life) and that patients in the hybrid rehabilitation groups will show more genuine upper extremity motor recovery than those in conventional rehabilitation groups, as indicated by kinematic measures.

The second aim will be to examine the comparative treatment effects between unilateral hybrid and bilateral hybrid rehabilitation on various aspects of outcomes. We hypothesize that the unilateral group will improve more on outcomes associated with distal upper limb (UL) control and that the bilateral rehabilitation group will improve more on outcomes associated with proximal UL control.

Third, we will collect biomarker indexes before and after the interventions to monitor the changes of oxidative stress and inflammatory levels. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

• NCT number: NCT01908361
• Study type: Interventional
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Status: Withdrawn
• Phase: N/A
• Start date: January 2014
• Completion date: December 2018