About this trial
This study proposes a novel stroke rehabilitation approach for upper extremity training by firstly combining different types of distal robot-assisted and task-oriented therapy in a circuit training program. The program could enhance UE functions, improving daily function, decrease caregiver burden and lower medical expenses associated with long-term care. Professionals can use these findings to promote the application of clinically empirical research and better understand the effects and mechanisms of circuit training.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
unilateral stroke ≥ 3 months onset
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56, indicating different levels of motor impairments ;
without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3 in proximal joints and modified Ashworth scale ≤2 in distal joints);
Mini Mental State Exam (MMSE) score > 24, indicating no serious cognitive impairment;
Disqualifiers
histories of other neurological diseases such as dementia, Parkinson's disease, and peripheral polyneuropathy;
difficulties in following and understanding instructions such as global aphasia;
enroll in other rehabilitation or drug studies simultaneously;
receiving Botulinum toxin injections within 3 months. -
Trial design
Parallel
Treatments tested in this trial
Robots can aid in distal UE rehabilitation through exoskeleton (EXO)
DeviceExoskeleton robot-assisted therapy Each EXO robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Hand of Hope (HOH) robotic hand system . HOH is an exoskeleton type of robot that is worn on the dorsal side of the impaired hand with 2 surface EMG sensors attached to the extensor digitorum and flexor digitorum superficialis.
End-effector robot-assisted therapy (EE)
DeviceEach EE robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Amadeo robotic system. Amadeo is an end-effector robot with 5 finger slides, which are attached to the fingertips and the thumb via magnetic finger pads. The integrated sensor for each finger allows the robot system to provide patients with real-time visual feedback of finger strengths and range of motion
Unilateral task-oriented therapy
BehavioralThe therapy will focus on task-oriented therapy with the affected UE and the training tasks involve proximal or distal UE movement, such as ringing a bell, picking up coins, grasping and releasing various cups, and other functional movements involved in daily activities. The level of challenge will be adapted according to patient ability and improvement during training.
Bilateral task-oriented therapy
BehavioralThe functional training tasks emphasize UE movements (gross or fine motor tasks) involved in daily activities but focus on both UEs moving synchronously, such as opening 2 closet doors, grasping and releasing 2 towels, wiping the table with 2 hands, and so on. The activities can also be graded in terms of difficulty and task requirements, according to the impairment level and the progression of the UE of each participant.
Treatment groups
Trial outcomes
Primary outcomes
Mini-Mental State Examination (MMSE)
The MMSE is a 30-point questionnaire that is the most commonly used brief screening tool for detecting cognitive impairment. Higher values represent better cognitive functioning. The MMSE has good psychometric properties for identifying cognitive impairment
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
The upper-extremity subscale of FMA will be used to assess sensorimotor impairment. The FMA-UE includes 33 items assessing movements, reflexes, and coordination of upper limbs. Each item is measured on a 3-point ordinal scale and the total score ranges from 0 to 66 . A higher score indicates better motor function. The reliability and validity of the Fugl-Meyer Assessment are well established
Modified Ashworth scale of muscle spasticity (MAS)
The MAS is a 6-point ordinal scale assessing muscle tone, where higher scores represent spasticity. The MAS scores of proximal and distal arm muscles will be examined. The MAS has good validity and reliability
Grip and pinch strength
The Jamar dynamometer is a standard, accurate, adjustable-handle tool specifically for measuring grip and pinch strength . Participants are asked to perform tasks under unilateral and bilateral conditions. In the unilateral condition, participants are asked to exert only with their paretic hands; in the bilateral condition, participants are asked to exert with both hands. Three trials will be taken at each assessment, and the average of three trials will be documented.
Sponsors and contacts
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