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

Buddhist Tzu Chi Medical Foundation

Status: Withdrawn

Conditions: Cerebrovascular Accident

Treatments: Behavioral: Conventional Rehabilitation; Behavioral: Unilateral Hybrid (InMotion3 plus CIT) Intervention; Behavioral: Bilateral Hybrid (BMT plus BAT) Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01908361

02-M04-022

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1 to 6 months onset from a first-ever unilateral stroke for the subacute randomized controlled trial (RCT), and more then 6 months after onset for the chronic RCT
• minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits)
• an initial FMA-UE score of 18 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment
• no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers)
• able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 24)
• without upper extremity fracture within 3 months
• no participation in any rehabilitation experiments or drug studies during the study period
• willing to provide written informed consent

Exclusion criteria

• acute inflammatory disease
• major health problems or poor physical condition that might limit participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Unilateral Hybrid (InMotion3 plus CIT) Intervention

Experimental group

Description:

Participants will receive 3 weeks of robot-assisted therapy (RT) using the InMotion3 Wrist Robot, followed by 3 weeks of CIT training.

Treatment:

Behavioral: Unilateral Hybrid (InMotion3 plus CIT) Intervention

Bilateral Hybrid (BMT plus BAT) Intervention

Experimental group

Description:

Participants in this bilateral treatment group will receive 3 weeks of RT using the Bi-Manu-Track (BMT) robot (Reha-Stim Co., Berlin, Germany), followed by 3 weeks of therapist-based BAT.

Treatment:

Behavioral: Bilateral Hybrid (BMT plus BAT) Intervention

Conventional Rehabilitation (CR)

Active Comparator group

Description:

The CR intervention will be designed to match the duration and intensity of the hybrid interventions.

Treatment:

Behavioral: Conventional Rehabilitation