Clinical trial NCT01767480: Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke
Official title: Effects and Mechanisms of Intensive Robot-Assisted Therapy in Patients With Subacute Stroke: Outcomes in Brain/Movement Reorganization, Sensorimotor and Daily Functions, and Physiological Markers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Intensive Robot Assisted Therapy
Subacute Stroke
Brain Reorganization
Sensory Motor
Physiological Marker
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: At baseline and immediately after the completion of intervention
measure: Motor Status Scale (MSS)
timeFrame: At baseline and immediately after the completion of intervention
measure: Modified Ashworth Scale (MAS)
timeFrame: At baseline and immediately after the completion of intervention
measure: MyotonPRO
timeFrame: At baseline and immediately after the completion of intervention
measure: Muscle metabolism (NIRS)
timeFrame: At baseline and immediately after the completion of intervention
measure: Box and Block Test (BBT)
timeFrame: At baseline and immediately after the completion of intervention
measure: Revised Nottingham Sensory Assessment (RNSA)
timeFrame: At baseline and immediately after the completion of intervention
measure: Functional Independence Measure (FIM)
timeFrame: At baseline and immediately after the completion of intervention
measure: Motor Activity Log (MAL)
timeFrame: At baseline, immediately after the completion of intervention, at a 6-month follow up
measure: ABILHAND Questionnaire
timeFrame: At baseline, immediately after the completion of intervention, at a 6-month follow up
measure: Adelaide Activities Profile (AAP)
timeFrame: At baseline, immediately after the completion of intervention, at a 6-month follow up
measure: EQ-5D-5L
timeFrame: At baseline and immediately after the completion of intervention
measure: Accelerometers
timeFrame: At baseline, immediately after the completion of intervention, at a 6-month follow-up.
measure: Functional magnetic resonance imaging (fMRI)
timeFrame: At baseline and immediately after the completion of intervention
measure: Kinematic analysis
timeFrame: At baseline and immediately after the completion of intervention
measure: Inflammatory markers
timeFrame: At baseline and immediately after the completion of intervention
measure: Oxidative stress markers
timeFrame: At baseline and immediately after the completion of intervention
measure: Erythrocyte deformability
timeFrame: At baseline and immediately after the completion of intervention
measure: Blood glucose indicators
timeFrame: At baseline and immediately after the completion of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kwei-Shan, Tao-Yuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.