Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke

NCT ID: NCT01767480

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-05-31

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 upper limb 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 optimal treatment intensity, and the impact on physiological responses is still lacking.

This trial is to examine (1) the immediate effects of treatment intensity in RT on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the physiological markers of inflammation, oxidative stress, and erythrocyte deformability. These overall findings will help better understanding of the efficacy of RT on functional outcomes, brain and movement reorganization, and physiological markers.

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 higher-intensity group, RT with lower-intensity group, and conventional intervention group. Assessments on sensorimotor impairments (Fugl Mayer Assessment, Motor Status Scale, Modified Ashworth Scale, Myoton, Muscle Metabolism, Box and Block Test, and Revised Nottingham Sensory assessment) and functional performance (Functional Independence Measure, Motor Activity Log, ABILHAND Questionnaire, Adelaide Activities Profile, EQ-5D-5L, and accelerometer) take about 40 minutes to complete. Evaluation of brain reorganization using functional magnetic resonance image and movement patterns by kinematic analysis take about 1 hour for each examination. Blood samples of the patients (12 ml.) will be collected to examine the physiological markers (ie, inflammation-related markers, oxidative stress markers, and erythrocyte deformability) before and after intervention. Total 24 ml blood will be collected in this study. Except for the blood taking, all the examinations are non-invasive.

Conditions

Stroke

Study Design

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

Study Groups

Higher-intensity RT group

All participants received a duration-matched intervention for 90-120 minutes/day, 5 days/week for 4 consecutive weeks. For the RT groups, they will receive RT training together with functional rehabilitation trainings. Within 1 training session, each patient in the higher-intensity RT group will use Bi-Manual-Tract to practice 400-600 repetitions of the mode 1 and 800-1000 repetitions of mode 2, totaling 1200-1600 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 100-200 repetitions in mode 3, if application.

Group Type: EXPERIMENTAL

RT

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.

Conventional rehabilitation (CR)

Intervention Type: BEHAVIORAL

CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.

Lower-intensity RT group

Patients in the lower-intensity RT received half the number of the repetitions per unit of time than patients in the higher-intensity RT group. Within 1 training session, patients in the lower-intensity RT group will practice 200-300 repetitions of the mode 1 and 400-500 repetitions of mode 2, totaling 600-800 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 50-100 repetitions in mode 3, if application.

Group Type: EXPERIMENTAL

RT

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.

Conventional rehabilitation (CR)

Intervention Type: BEHAVIORAL

CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.

Conventional rehabilitation (CR) group

The CR group will be designed to control for the duration of therapeutic activities. CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation (CR)

Intervention Type: BEHAVIORAL

CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.

Interventions

RT

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

Conventional rehabilitation (CR)

CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.

Intervention Type: BEHAVIORAL

Other Intervention Names

Bi-Manu-Track; Reha-Stim Co., Berlin, Germany; CR

Eligibility Criteria

Inclusion Criteria

• first episode of unilateral stroke
• time since stroke less than 3 months, i.e., acute or subacute stage
• initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment
• no serious cognitive impairment (i.e., Mini Mental State Exam score > 23)

Exclusion Criteria

• pregnant or breastfeeding women
• aphasia that might interfere with understanding instructions
• major health problems or poor physical conditions that might limit participation
• currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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

References

Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.

Reference Type: DERIVED

PMID: 34695300 (View on PubMed)

Other Identifiers

101-3905A3

Identifier Type: -

Identifier Source: org_study_id