Robotic Rehabilitation in Patients With Acute Stroke

Bahçeşehir University

Status: Completed

Conditions: Acute Stroke

Treatments: Other: Conventional physiotherapy; Device: EMG-driven exoskeleton hand robot

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03571529

Bahcesehir University

Details and patient eligibility

About

The advantage of the EMG-driven exoskeletons is that patient's own muscle power known as Residual Muscle Power is used to move the extremity while many other robotic devices work and drive impaired limb based on machine directed force. However, it is not clear which group of patients are suitable for EMG driven exoskeletons use and there has not been any established treatment protocol.

The aims of the study are 1- to investigate the effectiveness of the EMG-driven exoskeleton for hand rehabilitation in patients with acute stroke. 2- to understand which group of the patients may give the best response to the EMG-driven technology and how should be the treatment protocol designed.

Full description

Improving the rehabilitation outcome of the upper extremity in stroke patients has been an ongoing challenge in the rehabilitation field. Up to 85% of stroke survivors experience a certain degree of paresis of the upper limb at the onset and only 20% to 56% of survivors regain complete functional use of the affected upper limb despite the therapeutic interventions in first 3 months . Recovery of upper limb function is generally slower and non-complete.

To support and speed up a recovery process, there are many robotic devices currently used in the stroke units. Unlike one-on-one treatment applied by clinicans, robotic devices can provide repetitive, task oriented movements,with greater intensity, stimulating and engaging environment for user, hence alleviating the labour-intensive aspects of hands-on conventional therapy. There are a number of complex robotic devices that have been developed over the last two decades to assist upper arm training in rehabilitation.

Using EMG driven exoskeleton, commercially known as the Hand of Hope (HOH), has been shown its efficacy to improve patient's grip and pinch ability, muscle coordination and improve functional daily living tasks in patients even after 3,4,8,10 and 14 years after onset of the stroke. In addition to continuous investigation efforts needed to be spent, there has not been established any treatment protocol using EMG-driven exoskeletons. Since Stroke patients need to be focused on their own residual muscle power, clear indications for EMG-driven exoskeletons i.e., Hand of Hope, need to be established.

An investigation designed to highlight all these points will make an important contribution to the therapeutic approach using EMG-driven hand robotics for the hand rehabilitation after stroke.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having ischemic stroke history within last 4 weeks
• Being at the age 18 and older than 18
• Providing a sitting balance during the robot training (maximum 1 hour with preparation time)
• Understanding and performing simple commands
• Full range of motion in MCP, PIP and DIP
• MAS < 3 for finger flexors and extensors
• Participants who agree to participate in the study

Exclusion criteria

• Recurrent stroke
• Other neurologic or orthopedic problems that may affect to upper extremity functions
• Hemispatial neglect (will be diagnosed by Line bisection test and The star cancellation test)
• Refused treatment, non-cooperation
• MAS ≥ 3 (MAS will be measured every week during the treatment period)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Robotic rehabilitation

Active Comparator group

Description:

Active Comparator: Robotic rehabilitation Protocol with EMG-driven hand exoskeleton (Hand of Hope): Warm-up: 10 min passive mode 2 min resting Training: According to residual muscle power: * 10 min active-assistive, 2 min resting, 10 min Active-assistive or * 5 min active, 2 min resting, 15 min active assistive or * 10 min active, 2 min resting, 10 min active and * 10 min window cleaning game Robotic rehabilitation will be applied 5 times a week; Totally 15 sessions (3 weeks). Conventional physiotherapy also will be performed to the robotic rehabilitation group.

Treatment:

Device: EMG-driven exoskeleton hand robot

Other: Conventional physiotherapy

conventional physiotherapy

Active Comparator group

Description:

Conventional Physiotherapy will be performed to the both group 5 sessions a week and totally 15 sessions (3 weeks). Conventional physiotherapy will include neurophysiological approaches. Each session will last around 1,5 hours.

Treatment:

Other: Conventional physiotherapy