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Completed

NCT Number: NCT03571529

Robotic Rehabilitation in Patients With Acute Stroke

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dilber Karagozoglu Coskunsu

Istanbul, Europe, 34353, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EMG-driven exoskeleton hand robot

Device

Primary Outcome Measurement:

  • Fugl-Meyer Upper Extremity Assessment

Secondary Outcome Measurements:

  • Action Research Arm Test
  • Motor Activity Log
  • Data from force and EMG measurement records of HOH robot
  • Grip strength (with hand dynamometer)
  • Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers
  • Manuel muscle testing for wrist and finger muscles.
  • 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.

Conventional Physiotherapy

Other

Primary Outcome Measurement:

  • Fugl-Meyer Upper Extremity Assessment

Secondary Outcome Measurements:

  • Action Research Arm Test
  • Motor Activity Log
  • Data from force and EMG measurement records of HOH robot
  • Grip strength (with hand dynamometer)
  • Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers
  • Manuel muscle testing for wrist and finger muscles.
  • Modify Asworth sclale

Primary outcomes

  1. Fugl-Meyer Upper Extremity Assessment:

    Time frame: 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.

    Fugl-Meyer assessment was first used in 1975 to assess post-stroke physical performance. 33-item upper extremity subscale of the Fugl-Meyer scale evaluates movements, coordination/speed and pain in the shoulder, elbow, forearm. The highest score for the upper extremity is 66.

Secondary outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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.

    ARAT is a performance test, first described by Lyle in 1982. This test is produced by the upper extremity function test and shows upper extremity function and skill. ARAT consists of four subdivisions and 19 functional items that evaluate grasp, grip, pinch and gross motor movement on the both side. The highest score is 57.

  2. Motor Activity Log

    Time frame: 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.

    Motor Activity Log is a measure used to assess the amount of use and quality of movement of paretic arms and hands in daily living activities for hemiparetic stroke patients. It consists of 30 items.

  3. Manuel muscle testing

    Time frame: 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.

    manuel muscle testing of the flexor and extensor muscles of the wrist and finger

  4. Range of motion measurement (ROM)

    Time frame: 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.

    Active range of motion of the wrist, MCP, PIP and DIP joints

  5. Force and EMG measurement with the testing device

    Time frame: 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.

    Additional force and EMG measurement with the specially designed testing device

  6. hand dynamometer

    Time frame: 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.

    to measure grip strength

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Collaborators

  • Medical Park Hospital Istanbul
  • Medipol University
  • Rehab-Robotics Company Limited

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2018
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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