Differential Effectiveness of Robotic Assisted Therapy on Upper Extremity Function in Patients With Chronic Stroke

Chang Gung Medical Foundation

Status: Withdrawn

Conditions: Chronic Stroke

Treatments: Device: training systems

Study type: Interventional

Funder types: Other

Identifiers

NCT04260061

201900904A3

Details and patient eligibility

About

The objectives of this study are to: determine the effects of exoskeleton vs. end effector training systems on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in patients with chronic stroke.

Full description

According to the theory and literature review, there are two hypotheses in this study. One is that exoskeleton training system has better benefits than end-effector training system in motion control techniques, joint mobility and muscle tone control. Second, end-effector training system has better benefits than exoskeleton training system in the functional activity level and daily life participation.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Stroke more than 3 months.
• FMA score 29~59.
• Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
• Mini Mental State Examination ≥ 24 and no serious cognitive impairment.
• Learn more about the research content and can provide informed consent.

Exclusion criteria

• Other neurological disease
• Inability to understand instructions
• current participation in any other research
• Botulinum Toxin injection within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

exoskeleton group

Experimental group

Description:

The Hand of Hope therapy device will be used in this group. The hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need.

Treatment:

Device: training systems

end effector group

Experimental group

Description:

The Amadeo Hand-Therapy-System will be used in this group. The Amadeo is a mechatronic rehabilitation device that allows each individual finger to move independently and separately. The main target group are patients suffering from functional motor disabilities of the distal upper extremity. The Amadeo consists of the electrically driven moment mechanism, a supportive framework which is adjustable in height and includes a hand-arm support, and a control and operating unit (all-in-one PC). The finger slides can produce flexion/extension movement of the fingers and the thumb. The fingers and the thumb of the affected hand are attached to the slides and then passive, assistive, active or interactive therapy regime can be started. The integrated sensors for force and position measurement enable quantitative recording and evaluation of the finger range of movement and force.

Treatment:

Device: training systems