NCT01939041

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

Efficacy of Unilateral Versus Bilateral Approach to Robot-Assisted Rehabilitation on Motor Control/Performance, Daily Functions, and Physiological Responses in Patients With Subacute Stroke

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subacute stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 3 groups: RT with the InMotion3 (unilateral) robot group, RT with the Bi-Manu-Track (bilateral) robot group, and conventional intervention group. Assessments on motor impairments/performance (Fugl Mayer Assessment, Modified Ashworth Scale, MyotonePRO, Medical Research Council scale, Jamar dynamometer, and Action Research Arm Test) and daily functions (Motor Activity Log, ABILHAND Questionnaire, accelerometer, and Adelaide Activities Profile) take about 40 minutes to complete. Kinematic evaluation will take about 1 hour. Blood samples of the patients (12 ml.) will be collected to examine the physiological markers (ie, inflammation-related markers, oxidative stress markers, erythrocyte deformability, and blood glucose) before and after intervention. A total of 24 ml blood will be collected in this study. Except for the blood taking, all the examinations are non-invasive. Analysis of covariance (ANCOVA), controlling for the pretest differences, will be separately performed for each outcome measure to test the effects of different intervention groups.

Conditions

• Subacute Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-02-20
• Completion: 2017-02-20
• First posted: 2013-09-11
• Last updated: 2017-05-19

Locations

1 site across 1 country: Taiwan