StrokeNCT06382454
Upper Extremity Robot-Assisted Therapy in Stroke Patients
A study testing Assist-On Arm Robot Group in people with Stroke and Upper Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity
- What is being tested?
- Assist-On Arm Robot Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2024to 30 Mar 2025
- 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
- Spasticity of the upper extremity muscles is 2 or less according to the Modified Ashworth Scale
- Stroke patients with a Mini Mental State Examination score of 24 and above will be included in the study
Who cannot join
- Have a neurological disease other than stroke that may affect upper extremity movements
- Surgery or botox application for upper extremity spasticity in the last 6 months
- History of upper extremity fracture or surgery
- Attending another rehabilitation program
- Individuals who do not agree to participate in the study and do not give written informed consent will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Ender Ayvat, Assoc. Prof. contact
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, Altındağ, Ankara, 06100
About this study
Official title: Investigation of The Effect of Upper Extremity Robot-Assisted Therapy on Upper Extremity Performance in Stroke Patients
Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients.
- Conditions
- Stroke, Upper Extremity
- Being tested
- Assist-On Arm Robot Group, Control Group
- Keywords
- Stroke, Robot-Assisted Therapies, Upper Extremity, Exoskeleton Robot, Motor Performance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assist-On Arm Robot GroupDevice
Also called Assist-On Arm Robot
30 minutes of individualized trunk, lower extremity and upper extremity exercises; the other 30 minutes will be treated with the robotic system. In the robot-assisted treatment, a total of 12 movements will be used, including the movement patterns that patients have the most difficulty in daily life and two movement patterns used in the Proprioceptive Neuromuscular Facilitation approach. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day.
Control GroupOther
For 30 minutes, exercises including trunk, lower extremity and upper extremity exercises specific to the individual will be practiced, while the movement patterns to be used in the robotic system will be practiced in the other 30 minutes with the physiotherapist. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 30 minutes of individualized trunk, lower extremity and upper extremity exercises; the other 30 minutes will be treated with the robotic system. In the robot-assisted treatment, a total of 12 movements will be used, including the movement patterns that patients have the most difficulty in daily life and two movement patterns used in the Proprioceptive Neuromuscular Facilitation approach. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day. Receives: Device: Assist-On Arm Robot Group |
| Control Group | Active comparator | For 30 minutes, exercises including trunk, lower extremity and upper extremity exercises specific to the individual will be practiced, while the movement patterns to be used in the robotic system will be practiced in the other 30 minutes with the physiotherapist. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Spasticity of the patients will be evaluated with the Modified Ashworth Scale (MAS). The MAS, which assesses resistance to passive movement, is the most widely used method for the evaluation of muscle tone in the clinic. Spasticity is graded as 0, 1, 1+, 2, 3 and 4 according to the resistance of the muscle.
Measured: 5 minutes
Fugl-Meyer Assessment Upper Extremity
The Fugl Meyer Assessment is a disease-specific assessment designed to evaluate motor function, balance, sensory qualities and joint function in individuals after stroke. The scale consists of 5 sections: motor function, sensory function, balance (standing-sitting), range of motion and joint pain. Scoring is based on the ability to complete each item using a 3-point ordinal scale, where 0 = cannot perform, 1 = partially perform and 2 = fully perform. It is stated in the literature that the scale can also be divided. Therefore, in our study, the upper extremity part of the scale will be used in the evaluation of upper extremity performance before and after treatment. The total score that can be obtained from the Fugl Meyer Upper Extremity assessment is 66 and includes items evaluating joint movements, coordination-speed and reflex activities related to the shoulder, elbow, forearm, wrist and hand.
Measured: 15 minutes
Action Research Arm Test
Action Research Arm Test (ARAT) is a performance-based test that assesses upper extremity skills and functional level. The test has 4 subgroups evaluating coarse grasping, fine grasping, fingertip grasping and gross movement and 19 evaluation items in total. Scoring is between 0 and 3; 0 means 'movement cannot be performed at all' and 3 means 'performance is normal'. For the test, objects of special sizes and shapes suitable for the relevant grasping styles are required.
Measured: 15 minutes
Box and Block Test
The Box and Block Test, which provides a measure of manual dexterity, is administered with two adjacent boxes with a 15.2 cm high partition between them. One of the two boxes, both 53.7 x 25.4 x 8.5 cm in size, is filled with 150 wooden blocks of 2.5 cm3 each. The patient should attempt to move the maximum number of blocks within 60 seconds by grasping each block and carrying it across the compartment to the other compartment.
Measured: 1 minutes
Nine Hole Peg Test
The test consists of a platform with 9 holes and 9 rods. The platform will be placed directly in front of the individuals and the rods will be adjusted so that the rods are on the dominant hand side and the holes are on the non-dominant hand side. After the test rules are explained to the individuals, the individuals will be given the opportunity to practice before the application. Individuals will be asked to insert the rods on the board as fast as possible. The test results will be recorded by measuring the time from the moment the individuals touch the first stick to the moment the last stick is attached to the platform with a stopwatch. Then, they will be asked to remove the 9 bars one by one with the same hand and the removal time will be recorded. The test will be performed for the non-dominant hand using the same method, but this time the platform will be rotated in front of the non-dominant hand.
Measured: 10 minutes
Secondary outcomes (3)
ACTIVLIM
In the scale containing a total of 22 questions, the first 14 questions consist of activities involving adults and children. Questions 15-18 include activities specific to adults and questions 19-22 include activities specific to children. Since the study includes an adult group, the questionnaire including the first 18 questions will be applied to the stroke patients. When applying the ACTIVLIM scale, individuals will be asked to answer by thinking about the last 3 months. This questioning will be done in a way that the individual will be unassisted, independent of the extremity and strategy used. The scale is scored between 0 and 2. "0" means impossible, "1" means difficult, "2" means easy. Activities not performed in the last 3 months are not evaluated and the "question mark (?)" section is marked on the questionnaire page. As a result of the questionnaire, low score means clinically worse activity level and high score means clinically better activity level.
Measured: 5 minutes
ABILHAND Assessment
It is a scale that assesses the manual ability perceived by the individual in daily activities. In our study, the 23-item version of the scale developed for individuals with chronic stroke and including bimanual activities will be used. The scale has 23 items requiring the use of upper extremities and each item is scored as 0: impossible, 1: difficult, 2: easy. Activities not performed in the last 3 months are not scored.
Measured: 5 minutes
Stroke Impact Scale
Stroke Impact Scale 3.0; this scale, which aims to assess the perception of quality of life after stroke by patients themselves or their carers, consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point Likert scale. The score for each section ranges from 0 to 100. In addition to the 8 subsections, it also includes the evaluation of the perception of recovery after stroke with a 0-100 point visual analogue scale (0: No recovery, 100: Full recovery).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start6 May 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Interact Medical Technologies Inc.
- Responsible party
- Principal investigator, Izel Demirhan, Hacettepe University
- Investigators
- Muhammed Kılınç, Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382454
- Sponsor's protocol ID
- E2-23-5921
- Status last verified
- May 2024
- First submitted
- 27 Mar 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effect of Upper Extremity Robot-Assisted Therapy on Upper Extremity Performance in Stroke Patients
- ClinicalTrials.gov ID
- NCT06382454
- Acronym / sponsor ID
- E2-23-5921
- Conditions
- Stroke, Upper Extremity
- Keywords
- Stroke, Robot-Assisted Therapies, Upper Extremity, Exoskeleton Robot, Motor Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Interact Medical Technologies Inc.
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 24 Apr 2024 (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.
Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Assist-On Arm Robot Group30 minutes of individualized trunk, lower extremity and upper extremity exercises; the other 30 minutes will be treated with the robotic system. In the robot-assisted treatment, a total of 12 movements will be used, including the movement patterns that patients have the most difficulty in daily life and two movement patterns used in the Proprioceptive Neuromuscular Facilitation approach. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day. |
| Control Group | Active comparator | Other: Control GroupFor 30 minutes, exercises including trunk, lower extremity and upper extremity exercises specific to the individual will be practiced, while the movement patterns to be used in the robotic system will be practiced in the other 30 minutes with the physiotherapist. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Spasticity of the upper extremity muscles is 2 or less according to the Modified Ashworth Scale
- Stroke patients with a Mini Mental State Examination score of 24 and above will be included in the study
Key exclusion criteria (5 listed)
- Have a neurological disease other than stroke that may affect upper extremity movements
- Surgery or botox application for upper extremity spasticity in the last 6 months
- History of upper extremity fracture or surgery
- Attending another rehabilitation program
- Individuals who do not agree to participate in the study and do not give written informed consent will be excluded from the study.
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 |
|---|---|---|
| Assist-On Arm Robot GroupAlso: Assist-On Arm Robot30 minutes of individualized trunk, lower extremity and upper extremity exercises; the other 30 minutes will be treated with the robotic system. In the robot-assisted treatment, a total of 12 movements will be used, including the movement patterns that patients have the most difficulty in daily life and two movement patterns used in the Proprioceptive Neuromuscular Facilitation approach. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day. | Device | Treatment Group |
| Control GroupFor 30 minutes, exercises including trunk, lower extremity and upper extremity exercises specific to the individual will be practiced, while the movement patterns to be used in the robotic system will be practiced in the other 30 minutes with the physiotherapist. Individual-specific rehabilitation program; individual-specific trunk, lower extremity and upper extremity exercises to be applied in both groups will consist of the following exercises according to the needs of the patients, and the degree of difficulty will be planned according to the needs of the patients. All patients will be treated for 8 weeks, 3 days a week, 60 minutes a day. | Other | Control Group |
Primary outcome
Modified Ashworth Scale
Time frame: 5 minutes
Spasticity of the patients will be evaluated with the Modified Ashworth Scale (MAS). The MAS, which assesses resistance to passive movement, is the most widely used method for the evaluation of muscle tone in the clinic. Spasticity is graded as 0, 1, 1+, 2, 3 and 4 according to the resistance of the muscle.
Fugl-Meyer Assessment Upper Extremity
Time frame: 15 minutes
The Fugl Meyer Assessment is a disease-specific assessment designed to evaluate motor function, balance, sensory qualities and joint function in individuals after stroke. The scale consists of 5 sections: motor function, sensory function, balance (standing-sitting), range of motion and joint pain. Scoring is based on the ability to complete each item using a 3-point ordinal scale, where 0 = cannot perform, 1 = partially perform and 2 = fully perform. It is stated in the literature that the scale can also be divided. Therefore, in our study, the upper extremity part of the scale will be used in the evaluation of upper extremity performance before and after treatment. The total score that can be obtained from the Fugl Meyer Upper Extremity assessment is 66 and includes items evaluating joint movements, coordination-speed and reflex activities related to the shoulder, elbow, forearm, wrist and hand.
Action Research Arm Test
Time frame: 15 minutes
Action Research Arm Test (ARAT) is a performance-based test that assesses upper extremity skills and functional level. The test has 4 subgroups evaluating coarse grasping, fine grasping, fingertip grasping and gross movement and 19 evaluation items in total. Scoring is between 0 and 3; 0 means 'movement cannot be performed at all' and 3 means 'performance is normal'. For the test, objects of special sizes and shapes suitable for the relevant grasping styles are required.
Box and Block Test
Time frame: 1 minutes
The Box and Block Test, which provides a measure of manual dexterity, is administered with two adjacent boxes with a 15.2 cm high partition between them. One of the two boxes, both 53.7 x 25.4 x 8.5 cm in size, is filled with 150 wooden blocks of 2.5 cm3 each. The patient should attempt to move the maximum number of blocks within 60 seconds by grasping each block and carrying it across the compartment to the other compartment.
Nine Hole Peg Test
Time frame: 10 minutes
The test consists of a platform with 9 holes and 9 rods. The platform will be placed directly in front of the individuals and the rods will be adjusted so that the rods are on the dominant hand side and the holes are on the non-dominant hand side. After the test rules are explained to the individuals, the individuals will be given the opportunity to practice before the application. Individuals will be asked to insert the rods on the board as fast as possible. The test results will be recorded by measuring the time from the moment the individuals touch the first stick to the moment the last stick is attached to the platform with a stopwatch. Then, they will be asked to remove the 9 bars one by one with the same hand and the removal time will be recorded. The test will be performed for the non-dominant hand using the same method, but this time the platform will be rotated in front of the non-dominant hand.
3 secondary outcomes
ACTIVLIM
Time frame: 5 minutes
ABILHAND Assessment
Time frame: 5 minutes
Stroke Impact Scale
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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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.
Ender Ayvat, Assoc. Prof. contact
Muhammed Kılınç, Prof. study director
Hacettepe 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 Assist-On Arm Robot Group in people with Stroke and Upper Extremity, run by Hacettepe 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 2 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İzel Demirhan, Msc (+905379858812, izel.dmrhn16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: 5 minutes). The study lists 5 primary outcomes in all. 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 7 May 2024.