Acute StrokeNCT03571529
Robotic Rehabilitation in Patients With Acute Stroke
A study testing EMG-driven exoskeleton hand robot and Conventional physiotherapy in people with Acute Stroke, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- EMG-driven exoskeleton hand robot and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dilber Karagozoglu Coskunsu
Istanbul, Europe, 34353
About this study
Official title: The Effect of EMG-Driven Exoskeleton Robotic Rehabilitation on Improving Hand Functions in Acute Stroke Patients
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.
Read the 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
- Being tested
- EMG-driven exoskeleton hand robot, Conventional physiotherapy
- Keywords
- EMG driven exoskeleton, hand rehabilitation, hand function, upper extremity outcome
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG-driven exoskeleton hand robotDevice
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 physiotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Robotic rehabilitation | Active comparator | 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. Receives: Device: EMG-driven exoskeleton hand robot; Other: Conventional physiotherapy |
| conventional physiotherapy | Active comparator | 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. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
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.
Measured: 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.
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.
Measured: 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.
Manuel muscle testing
manuel muscle testing of the flexor and extensor muscles of the wrist and finger
Measured: 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.
Range of motion measurement (ROM)
Active range of motion of the wrist, MCP, PIP and DIP joints
Measured: 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.
Force and EMG measurement with the testing device
Additional force and EMG measurement with the specially designed testing device
Measured: 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.
hand dynamometer
to measure grip strength
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start6 Apr 2018
- Primary completion31 Mar 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University, Medical Park Hospital Istanbul, Rehab-Robotics Company Limited
- Responsible party
- Principal investigator, Dilber Karagozoglu Coskunsu, Bahçeşehir University
- Investigators
- Dilber Karagozoglu Coskunsu, Ass.Prof., Principal investigator, Bahçeşehir UniversitySumeyye Akcay, PT, Study chair, Bahçeşehir UniversityÖzden Erkan Oğul, Ass.Prof., Study chair, Medipol UniversityKubra Yıldırım, PT, Study chair, IAU Medical Park Florya HospitalYakup Krespi, Prof., Study chair, IAU Medical Park Florya HospitalHaris Begovic, PhD, Study chair, The Hong Kong Polytechnic UniversityNecla Öztürk, Prof., Study chair, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571529
- Sponsor's protocol ID
- Bahcesehir University
- Status last verified
- Sep 2021
- First submitted
- 22 Apr 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of EMG-Driven Exoskeleton Robotic Rehabilitation on Improving Hand Functions in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT03571529
- Acronym / sponsor ID
- Bahcesehir University
- Conditions
- Acute Stroke
- Keywords
- EMG driven exoskeleton, hand rehabilitation, hand function, upper extremity outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Medipol University, Medical Park Hospital Istanbul, Rehab-Robotics Company Limited
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic rehabilitation | Active comparator | Device: EMG-driven exoskeleton hand robot, Other: Conventional physiotherapyActive 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 | Active comparator | Other: Conventional physiotherapyConventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG-driven exoskeleton hand robotPrimary 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. | Device | Robotic rehabilitation |
| Conventional physiotherapyPrimary 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 | Other | Robotic rehabilitation, conventional physiotherapy |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilber Karagozoglu Coskunsu, Ass.Prof. principal investigator
Bahçeşehir University
Sumeyye Akcay, PT study chair
Bahçeşehir University
Özden Erkan Oğul, Ass.Prof. study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG-driven exoskeleton hand robot and Conventional physiotherapy in people with Acute Stroke, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.