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Robotic Rehabilitation in Patients With Acute Stroke

Primary Purpose

Acute Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EMG-driven exoskeleton hand robot
Conventional physiotherapy
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring EMG driven exoskeleton, hand rehabilitation, hand function, upper extremity outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Dilber Karagozoglu Coskunsu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Robotic rehabilitation

conventional physiotherapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity Assessment:
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 Outcome Measures

Action Research Arm Test (ARAT)
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.
Motor Activity Log
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.
Manuel muscle testing
manuel muscle testing of the flexor and extensor muscles of the wrist and finger
Range of motion measurement (ROM)
Active range of motion of the wrist, MCP, PIP and DIP joints
Force and EMG measurement with the testing device
Additional force and EMG measurement with the specially designed testing device
hand dynamometer
to measure grip strength

Full Information

First Posted
April 22, 2018
Last Updated
September 13, 2021
Sponsor
Bahçeşehir University
Collaborators
Medipol University, Medical Park Hospital Istanbul, Rehab-Robotics Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03571529
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University
Collaborators
Medipol University, Medical Park Hospital Istanbul, Rehab-Robotics Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
EMG driven exoskeleton, hand rehabilitation, hand function, upper extremity outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic rehabilitation
Arm Type
Active Comparator
Arm 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.
Arm Title
conventional physiotherapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
EMG-driven exoskeleton hand robot
Intervention Description
Primary Outcome Measurement: 1. 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.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Primary Outcome Measurement: 1. 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 Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity Assessment:
Description
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.
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.
Secondary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
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.
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.
Title
Motor Activity Log
Description
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.
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.
Title
Manuel muscle testing
Description
manuel muscle testing of the flexor and extensor muscles of the wrist and finger
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.
Title
Range of motion measurement (ROM)
Description
Active range of motion of the wrist, MCP, PIP and DIP joints
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.
Title
Force and EMG measurement with the testing device
Description
Additional force and EMG measurement with the specially designed 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.
Title
hand dynamometer
Description
to measure grip strength
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilber Karagozoglu Coskunsu, Ass.Prof.
Organizational Affiliation
Bahçeşehir University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sumeyye Akcay, PT
Organizational Affiliation
Bahçeşehir University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Özden Erkan Oğul, Ass.Prof.
Organizational Affiliation
Medipol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kubra Yıldırım, PT
Organizational Affiliation
IAU Medical Park Florya Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yakup Krespi, Prof.
Organizational Affiliation
IAU Medical Park Florya Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haris Begovic, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Necla Öztürk, Prof.
Organizational Affiliation
Maltepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Dilber Karagozoglu Coskunsu
City
Istanbul
State/Province
Europe
ZIP/Postal Code
34353
Country
Turkey

12. IPD Sharing Statement

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Robotic Rehabilitation in Patients With Acute Stroke

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