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

NCT ID: NCT01939041

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-01
• Study Completion Date: 2017-02-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robot-assisted therapy with InMotion3 (IMT)

We will use the InMotion3 Wrist Robot (Figure 1) for the IMT group. During the InMotion3 therapy (IMT) session, participants will receive 5-minute of muscle tone normalization preparation and passive range of motion, then a 70-minute robot-assisted training followed by a 15-minute functional training. During the robot-assisted training, only the paretic hand will be trained and the participant will rest the forearm and hand on a cradle and the wrist and hand in a fixed positions. During the practice, a visual display will provide online visual feedback of accuracy and coordination success. And summary scores regarding movement accuracy and movement smoothness will be shown on the display periodically. After each IMT session, a 15 min functional task practice will be provided as described in the previous paragraph.

Group Type: EXPERIMENTAL

InMotion3 (IMT)

Intervention Type: DEVICE

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.

Robot-assisted therapy with Bi-Manu-Track (BMT)

During the Bi-Manu-Track training (BMT), participant will use both nonparetic and paretic hands. Participants will receive 5-munite of muscle tone normalization preparation and passive range of motion, then will practice about 5-minute in Mode 1, 25-minute in Mode 2, and 5-minute in Mode 3 in wrist and forearm respectively. The training repetitions of each mode fall within the range of the protocols used in previous studies which would not cause adverse events (Hesse et al., 2005). The total minutes of each robot-assisted will be 70 minutes. After each BMT session, a 15 min functional task practice will be provided based on the same principles as the one in the IMT group.

Group Type: EXPERIMENTAL

Bi-Manu-Track (BMT)

Intervention Type: DEVICE

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.

Control intervention group (CI)

The 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.

Group Type: ACTIVE_COMPARATOR

Control intervention (CI)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

InMotion3 Wrist Robot; INMOTION Mechanical chair; INTERACTIVE MOTION TECHNOLOGIES, INC; Bi-Manu-Track; Reha-Stim Co., Berlin, Germany

Eligibility Criteria

Inclusion Criteria

• first episode of stroke in cortical regions
• time since stroke less than 6 months and more than 2 weeks, i.e., subacute stage
• initial motor part of UE of FMA score ranging from 24 to 52, indicating moderate to severe movement impairment
• no serious cognitive impairment (i.e., Mini Mental State Exam score > 24)

Exclusion Criteria

• aphasia that might interfere with understanding instructions
• chronic inflammatory, autoimmune and hematological disorders
• intake of anti-inflammatory drugs
• major health problems or poor physical conditions that might limit participation
• current participation in any other research

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Kwei-Shan, Tao-Yuan, Taiwan

Countries

Taiwan

Other Identifiers

101-5194A3

Identifier Type: -

Identifier Source: org_study_id