StrokeNCT06692829
Robot-Assisted Therapy in Chronic Stroke Patients
A study testing robotic rehabilitation and conventional rehabilitation in people with Stroke and Hemiplegia, run by Afyonkarahisar Health Sciences University.
Trial summary
Considering the paucity of studies on robotic hand therapy, larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- robotic rehabilitation and conventional rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who were 3 months post-CVA
- whose health status was suitable for rehabilitation
- who could understand commands with a mini mental test score of 15 and above.
Who cannot join
- Patients with persistent upper extremity pain on the hemiplegic side (VAS\>40)
- severe spasticity in the hand (MAS≥3)
- contracture in the hand
- fracture or surgery on the hemiplegic side within the last 6 months
- botulinum toxin injection into the upper extremity within the last 6 months
- skin ulcers
Show all 10Show fewer
- brainstem or cerebellar lesions
- neglect or apraxia
- severe visual defects
- severe depression
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effects of Robot-Assisted Therapy Added to Conventional Therapy on Hand Functions, Spasticity and Quality of Life in Patients With Chronic Stroke: A Randomized Controlled Trial
Considering the paucity of studies on robotic hand therapy, larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.
Read the detailed description
Stroke is one of the leading causes of disability worldwide. Although mortality is decreasing, the number of people living with the effects of stroke has increased due to the increasing and aging population. It has been observed that 26% of patients have decreased basic daily living activities and 50% have decreased mobility after stroke.
Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises performed with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come to the fore in recent years. Robot-assisted treatment (RAT) is one of these new treatment approaches. The use of robotic technology in rehabilitation has gained importance especially in the last 15 years and developments in this regard continue to increase. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.
This technology-based treatment increases the efficiency of rehabilitation care with its features of intensity, interaction, flexibility and adaptability to the patient performance and needs. It has no significant side effects and is well tolerated by patients. In the literature on robot-assisted treatment, different robotic devices have been used in various studies and different treatment protocols have been applied. This treatment has been reported to provide significantly greater improvement in function compared to conventional usual care. Studies in the literature on RAT demonstrate the feasibility of using these technologies in large patient groups.
The most common and devastating consequence of post-stroke disability is functional disability in the upper extremity. The functional prognosis of the lower extremity is generally better than the upper extremity after stroke. 20-30% of patients can walk normally, and 75% can reach some stage of ambulation. However, only 5% of patients return to normal upper extremity function, while 23-43% show inadequate functional recovery. Therefore, upper extremity rehabilitation requires more time and effort than lower extremity rehabilitation.
Bertani et al. In their published meta-analysis, they stated that robot-assisted rehabilitation is more effective in improving upper extremity motor function, especially in patients with chronic stroke, compared to conventional therapy. Amadeo (Tyromotion, Graz, Austria), an end-effector robotic rehabilitation device designed for hand rehabilitation, has shown feasibility and preliminary efficacy for stroke in the subacute phase. A randomized controlled trial with 17 patients compared conventional occupational therapy with Amadeo robotic therapy and after forty sessions, both groups showed significant improvement, but robotic intervention caused a greater improvement in hand function as measured by Fugl-Meyer and Motricity Index. Robotic hand therapy has started to take its place in routine rehabilitation protocols today. Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.
- Conditions
- Stroke, Hemiplegia
- Being tested
- robotic rehabilitation, conventional rehabilitation
- Keywords
- stroke, hemiplegia, robotic rehabilitation, hand function
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic rehabilitationProcedure or surgery
In addition to conventional therapy, the robotic therapy group was planned to receive robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 45 minutes, accompanied by a physiotherapist trained in robotic rehabilitation and with at least 5 years of experience. A total of 20 treatment sessions will be applied 2 days a week.
conventional rehabilitationProcedure or surgery
It was planned for the conventional therapy group to receive an exercise program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. A total of 20 treatment sessions will be applied 2 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | It was planned for the conventional therapy group to receive an exercise program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. A total of 20 treatment sessions will be applied 2 days a week. Receives: Procedure: conventional rehabilitation |
| Robot Assisted Therapy | Experimental | In addition to conventional therapy, the robotic therapy group was planned to receive robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 45 minutes, accompanied by a physiotherapist trained in robotic rehabilitation and with at least 5 years of experience. A total of 20 treatment sessions will be applied 2 days a week. Receives: Procedure: robotic rehabilitation; Procedure: conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brunnstrom Staging
is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In the Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.
Measured: Before treatment (T0) At the end of the treatment (10. week) (T1)
Modified Ashworth Scale
Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.
Measured: Before treatment (T0) At the end of the treatment (10. week) (T1)
Fugl Meyer Upper Extremity Assessment Questionnaire
The Fugl-Meyer Upper Extremity Motor Assessment Scale (FMUE Scale) was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom\'s stages of motor recovery. The FMUE Scale consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66.
Measured: Before treatment (T0) At the end of the treatment (10. week) (T1)
ABILHAND Stroke Hand Function Questionnaire
ABILHAND Hand Questionnaire was developed in 1998 to measure the hand skill perceived by the patient. It contains 23 questions about how much difficulty the patient has in performing the activities. One of the options impossible (0 points), difficult (1 point), easy (2 points) is marked. The total score is 46.
Measured: Before treatment (T0) At the end of the treatment (10. week) (T1)
Secondary outcomes (3)
Mini Mental Test
The Mini Mental State Examination is a widely used cognitive screening test. The total score is 30 points. It has been stated that scores below 15 indicate low cognitive function, scores between 15-26 indicate moderate, and scores above 26 indicate high cognitive level. Turkish validity studies have been conducted in the normal population and in patients with traumatic brain injury.
Measured: Before treatment (T0) At the end of the treatment (10. week) (T1)
Stroke Impact Survey
The Stroke Impact Scale (SIS) is a stroke-specific health status measure. It consists of 59 items and 8 sections. The patient is asked to rate the difficulty experienced in completing each item in the past week on a five-point Likert scale. A score of one indicates that the patient was unable to complete the item, and a score of five indicates that the patient had no difficulty in completing it. It also includes a visual analog scale (0: No improvement, 100: Full improvement) regarding the perception of general recovery after stroke. Validity and reliability studies have been conducted in Turkish.
Measured: Before treatment (T0) At the end of the treatment (10. week) (T1)
Stroke Specific Quality of Life Scale (SSQOL)
SSQOL is a stroke-specific, patient-centered quality of life measure. SSQOL contains 49 items and consists of 12 domains; mobility, energy, upper extremity function, work/production, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Each domain consists of at least 3 items, and each item is evaluated on a 5-point Likert scale considering the past week. Higher scores reflect better function. It has been shown to be valid and reliable for the Turkish population.
Measured: Before treatment (T0) At the end of the treatment (10. week) (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Adar, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692829
- Sponsor's protocol ID
- SAROBOT2
- Status last verified
- Nov 2024
- First submitted
- 3 Sep 2024
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Robot-Assisted Therapy Added to Conventional Therapy on Hand Functions, Spasticity and Quality of Life in Patients With Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06692829
- Acronym / sponsor ID
- SAROBOT2
- Conditions
- Stroke, Hemiplegia
- Keywords
- stroke, hemiplegia, robotic rehabilitation, hand function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 18 Nov 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.
Considering the paucity of studies on robotic hand therapy, larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.
Detailed description
Stroke is one of the leading causes of disability worldwide. Although mortality is decreasing, the number of people living with the effects of stroke has increased due to the increasing and aging population. It has been observed that 26% of patients have decreased basic daily living activities and 50% have decreased mobility after stroke.
Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises performed with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come to the fore in recent years. Robot-assisted treatment (RAT) is one of these new treatment approaches. The use of robotic technology in rehabilitation has gained importance especially in the last 15 years and developments in this regard continue to increase. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.
This technology-based treatment increases the efficiency of rehabilitation care with its features of intensity, interaction, flexibility and adaptability to the patient performance and needs. It has no significant side effects and is well tolerated by patients. In the literature on robot-assisted treatment, different robotic devices have been used in various studies and different treatment protocols have been applied. This treatment has been reported to provide significantly greater improvement in function compared to conventional usual care. Studies in the literature on RAT demonstrate the feasibility of using these technologies in large patient groups.
The most common and devastating consequence of post-stroke disability is functional disability in the upper extremity. The functional prognosis of the lower extremity is generally better than the upper extremity after stroke. 20-30% of patients can walk normally, and 75% can reach some stage of ambulation. However, only 5% of patients return to normal upper extremity function, while 23-43% show inadequate functional recovery. Therefore, upper extremity rehabilitation requires more time and effort than lower extremity rehabilitation.
Bertani et al. In their published meta-analysis, they stated that robot-assisted rehabilitation is more effective in improving upper extremity motor function, especially in patients with chronic stroke, compared to conventional therapy. Amadeo (Tyromotion, Graz, Austria), an end-effector robotic rehabilitation device designed for hand rehabilitation, has shown feasibility and preliminary efficacy for stroke in the subacute phase. A randomized controlled trial with 17 patients compared conventional occupational therapy with Amadeo robotic therapy and after forty sessions, both groups showed significant improvement, but robotic intervention caused a greater improvement in hand function as measured by Fugl-Meyer and Motricity Index. Robotic hand therapy has started to take its place in routine rehabilitation protocols today. Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Procedure: conventional rehabilitationIt was planned for the conventional therapy group to receive an exercise program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. A total of 20 treatment sessions will be applied 2 days a week. |
| Robot Assisted Therapy | Experimental | Procedure: robotic rehabilitation, Procedure: conventional rehabilitationIn addition to conventional therapy, the robotic therapy group was planned to receive robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 45 minutes, accompanied by a physiotherapist trained in robotic rehabilitation and with at least 5 years of experience. A total of 20 treatment sessions will be applied 2 days a week. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- who were 3 months post-CVA
- whose health status was suitable for rehabilitation
- who could understand commands with a mini mental test score of 15 and above.
Key exclusion criteria (10 listed)
- Patients with persistent upper extremity pain on the hemiplegic side (VAS\>40)
- severe spasticity in the hand (MAS≥3)
- contracture in the hand
- fracture or surgery on the hemiplegic side within the last 6 months
- botulinum toxin injection into the upper extremity within the last 6 months
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 |
|---|---|---|
| robotic rehabilitationIn addition to conventional therapy, the robotic therapy group was planned to receive robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 45 minutes, accompanied by a physiotherapist trained in robotic rehabilitation and with at least 5 years of experience. A total of 20 treatment sessions will be applied 2 days a week. | Procedure or surgery | Robot Assisted Therapy |
| conventional rehabilitationIt was planned for the conventional therapy group to receive an exercise program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. A total of 20 treatment sessions will be applied 2 days a week. | Procedure or surgery | Conventional Therapy, Robot Assisted Therapy |
Primary outcome
Brunnstrom Staging
Time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In the Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.
Modified Ashworth Scale
Time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.
Fugl Meyer Upper Extremity Assessment Questionnaire
Time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
The Fugl-Meyer Upper Extremity Motor Assessment Scale (FMUE Scale) was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom\'s stages of motor recovery. The FMUE Scale consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66.
ABILHAND Stroke Hand Function Questionnaire
Time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
ABILHAND Hand Questionnaire was developed in 1998 to measure the hand skill perceived by the patient. It contains 23 questions about how much difficulty the patient has in performing the activities. One of the options impossible (0 points), difficult (1 point), easy (2 points) is marked. The total score is 46.
3 secondary outcomes
Mini Mental Test
Time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
Stroke Impact Survey
Time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
Stroke Specific Quality of Life Scale (SSQOL)
Time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing robotic rehabilitation and conventional rehabilitation in people with Stroke and Hemiplegia, run by Afyonkarahisar Health Sciences University.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEVDA ADAR (+902722463335, drsevdaadar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brunnstrom Staging (time frame: Before treatment (T0) At the end of the treatment (10. week) (T1)). The study lists 4 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 18 Nov 2024.