Clinical trial NCT01939041: Efficacy of Unilateral Versus Bilateral Approach to Robot-Assisted Rehabilitation in Patients With Subacute Stroke
Official title: Efficacy of Unilateral Versus Bilateral Approach to Robot-Assisted Rehabilitation on Motor Control/Performance, Daily Functions, and Physiological Responses in Patients With Subacute Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Subacute Stroke
Keywords: Subacute Stroke
Unilateral Robot-Assisted Training
Bilateral Robot-Assisted Training
Motor control
Physiological Response
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 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.

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

Primary outcomes:
measure: Change of Kinematic analysis
timeFrame: Change from baseline in kinematic analysis immediately after the completion of intervention
measure: Changes of Fugl-Meyer Assessment (FMA)
timeFrame: Change from baseline in Fugl-Meyer Assessment immediately after the completion of intervention and at a 6-month follow-up
measure: Changes of Modified Ashworth Scale (MAS)
timeFrame: Changes from baseline in Modified Ashworth Scale immediately after the completion of intervention and at a 6-month follow-up
measure: Changes of MyotonPRO
timeFrame: Changes from baseline in MyotonPRO immediately after the completion of intervention and at a 6-month follow-up
measure: Changes of Medical Research Council scale (MRC)
timeFrame: Changes from baseline in Medical Research Council scale immediately after the completion of intervention and at a 6-month follow-up
measure: Changes of the Jamar dynamometer
timeFrame: Changes from baseline in the Jamar dynamometer immediately after the completion of intervention and at a 6-month follow-up.
measure: Changes of Action Research Arm Test (ARAT)
timeFrame: Changes from baseline in Action Research Arm Test immediately after the completion of intervention and at a 6-month follow-up
measure: Changes of Motor Activity Log (MAL)
timeFrame: Changes from baseline in Motor Activity Log immediately after the completion of intervention and at a 6-month follow-up
measure: Changes of ABILHAND Questionnaire
timeFrame: Changes from baseline in ABILHAND Questionnaire immediately after the completion of intervention and at a 6-month follow-up
measure: Change of Accelerometers
timeFrame: Change from baseline in accelerometers immediately after the completion of intervention
measure: Changes of Adelaide Activities Profile (AAP)
timeFrame: Changes from baseline in Adelaide Activities Profile immediately after the completion of intervention and at a 6-month follow-up
Secondary outcomes:
measure: Change of inflammatory markers
timeFrame: Change from baseline in inflammatory markers immediately after the completion of intervention
measure: Change of oxidative stress markers
timeFrame: Change from baseline in oxidative stress markers immediately after the completion of intervention
measure: Change of erythrocyte deformability
timeFrame: Change from baseline in erythrocyte deformability immediately after the completion of intervention
measure: Change of blood glucose indicators
timeFrame: Change from baseline in blood glucose indicators immediately after the completion of intervention
Other outcomes:
Locations:
city: Kwei-Shan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Tao-Yuan
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: