Clinical trial NCT03571529: Robotic Rehabilitation in Patients With Acute Stroke
Official title: The Effect of EMG-Driven Exoskeleton Robotic Rehabilitation on Improving Hand Functions in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: EMG driven exoskeleton
hand rehabilitation
hand function
upper extremity outcome
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
Collaborators: name: Medipol University
name: Medical Park Hospital Istanbul
name: Rehab-Robotics Company Limited
First posted: 2018-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Assessment:
timeFrame: Change from pre-interventional Fugl-Meyer Upper Extremity score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Change from pre-interventional ARAT score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.
measure: Motor Activity Log
timeFrame: Change from pre-interventional Motor Activity Log score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.
measure: Manuel muscle testing
timeFrame: Change from pre-interventional Manuel muscle testing scores at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.
measure: Range of motion measurement (ROM)
timeFrame: Change from pre-interventional ROMs at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks.
measure: Force and EMG measurement with the testing device
timeFrame: Change from pre-interventional force and EMG measurement with the testing device at the end of the 5th session, 10th session and 15 session intervention that will be performed at the last session of each week at a total of 3 weeks.
measure: hand dynamometer
timeFrame: Change from pre-interventional grip strentgh at the end of the 15 session interventions that will be performed 5 days in a week at a total of 3 weeks.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dilber Karagozoglu Coskunsu
state: Europe
Study officials:
affiliation: Bahçeşehir University
name: Dilber Karagozoglu Coskunsu, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahçeşehir University
name: Sumeyye Akcay, PT
role: STUDY_CHAIR
affiliation: Medipol University
name: Özden Erkan Oğul, Ass.Prof.
role: STUDY_CHAIR
affiliation: IAU Medical Park Florya Hospital
name: Kubra Yıldırım, PT
role: STUDY_CHAIR
affiliation: IAU Medical Park Florya Hospital
name: Yakup Krespi, Prof.
role: STUDY_CHAIR
affiliation: Hong Kong Polytechnic University
name: Haris Begovic, PhD
role: STUDY_CHAIR
affiliation: Maltepe University
name: Necla Öztürk, Prof.
role: STUDY_CHAIR
References: