NCT03571529

Robotic Rehabilitation in Patients With Acute Stroke

The Effect of EMG-Driven Exoskeleton Robotic Rehabilitation on Improving Hand Functions in Acute Stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bahçeşehir University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
DEVICE	EMG-driven exoskeleton hand robot	Primary Outcome Measurement: 1\. Fugl-Meyer Upper Extremity Assessment Secondary Outcome Measurements: 1. Action Research Arm Test 2. Motor Activity Log 3. Data from force and EMG measurement records of HOH robot 4. Grip strength (with hand dynamometer) 5. Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers 6. Manuel muscle testing for wrist and finger muscles. 7. Modify Asworth sclale At the beginning of each robotic treatment session, superficial EMG recording will be taken at relax position ( without muscle contraction) and then during maximal voluntary isometric contraction (MVC) after the patient's hand is placed in the exoskeleton. For both, EMG recording is performed for 7 seconds and Root Mean Square (RMS) is calculated from this record.
OTHER	Conventional physiotherapy	Primary Outcome Measurement: 1\. Fugl-Meyer Upper Extremity Assessment Secondary Outcome Measurements: 1. Action Research Arm Test 2. Motor Activity Log 3. Data from force and EMG measurement records of HOH robot 4. Grip strength (with hand dynamometer) 5. Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers 6. Manuel muscle testing for wrist and finger muscles. 7. Modify Asworth sclale

Timeline

• Start date: 2018-04-06
• Primary completion: 2020-03-31
• Completion: 2020-05-31
• First posted: 2018-06-27
• Last updated: 2021-09-14

Locations

1 site across 1 country: Turkey (Türkiye)