Efficacy of Unilateral Versus Bilateral Approach to Robot-Assisted Rehabilitation in Patients With Subacute Stroke

Summary

Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving UL function after stroke. All these robotic devices have been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for the mechanisms of RT-induced recovery, the relative treatment effects of unilateral vs bilateral robotic trainings, and the impact on physiological responses is still lacking.

The primary purposes of this study are to examine (1) the relative immediate treatment effects of unilateral vs bilateral RT on motor impairments/performance and daily functions in patients with subacute stroke; (2) the long-term benefits of unilateral vs bilateral RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on movement reorganization as well as on the physiological markers of inflammation, oxidative stress, erythrocyte deformability, and blood glucose. These overall findings will help better understanding of the efficacy of RT on functional outcomes, movement reorganization, and physiological markers. The investigators would additionally explore the possible differential treatment effects in patients with different levels of motor severity (i.e., moderate vs. severe).

The investigators hypothesize that (1) both unilateral (the InMotion3) and bilateral (the Bi-Manu-Track) robot-assisted training would bring larger benefits on motor performance and daily function than the control treatment; (2) such benefits would retain during the follow-up; (3) there would be differential immediate and retention effects of unilateral (the InMotion3) and bilateral (the Bi-Manu-Track) robot-assisted training on different outcome measures; (4) better movement reorganization as well as physiological marker expressions would be found in both robotic groups compared to control group; and (5) there would be differential effects of robotic therapy between participants with moderate vs. severe motor impairment.

Conditions

• Subacute Stroke

Interventions

DEVICE

InMotion3 (IMT)

Participant will practice about 2-5-minute of passive, 25-30-minute of assisted-active, and 3-5-minute of active motions in wrist and forearm respectively. The wrist motions will include flexion, extension, radial deviation, and ulnar deviation. Forearm motions will include supination and pronation. During the practice, a visual display will provide online visual feedback of accuracy and coordination success.

DEVICE

Bi-Manu-Track (BMT)

The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns in conjunction with computer games: forearm pronation-supination and wrist flexion-extension. Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually. The device has a mechanical breaking of the movement when the torques exceeded 4 Nm, emergency breaks in the reach of the patients, skin friendly materials, and minimal risk for contusions.

BEHAVIORAL

Control intervention (CI)

he control group's therapy will be designed to control for the duration and intensity of the robot-assisted training (90 min/day, 5 days/wk, for 4 wk). The therapeutic activities in the control group will involve passive range of motion, weight bearing, stretching, strengthening of the paretic arm, gross motor activities, coordination tasks, unilateral and bilateral fine motor tasks, transition, mobility, and posture/balance.

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Ching-Yi Wu, ScD · Chang Gung Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-01

Primary Completion

2017-02-20

Completion

2017-02-20

Countries

• Taiwan