StrokeNCT05601115
The Effect of Combined Robotic Hand Therapy and Conventional Therapy in Stroke Patients
A study testing Robot assisted therapy and Conventional Therapy Group in people with Stroke and Robot Assisted Therapy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.The aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Robot Assisted Therapy, Robotic Rehabilitation
- What is being tested?
- Robot assisted therapy and Conventional Therapy Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Jun 2023
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral stroke
- Between 4 weeks and 6 months after stroke
- health status was suitable for rehabilitation
- who could understand commands with a mini mental test score of 15 and above
- who had Brunnstrom grade 3 and below (≤3).
- -
Who cannot join
- Patients with persistent upper extremity pain on the hemiplegic side (VAS>40)
- Patients with severe spasticity in the hand (MAS≥3)
- Patients with contractures in the hand
- Patients who had fractures or operations on the hemiplegic side in the last 6 months
- Patients who received botulinum toxin injection to the upper extremity in the last 6 months
- Patients with skin ulcers
Show all 10Show fewer
- Patients with brain stem or cerebellar lesions
- Patients with neglect or apraxia
- Patients with severe visual impairment and severe depression
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combined Robotic Hand Therapy and Conventional Therapy to Rehabilitation Outcomes in Stroke Patients
RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.The aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.
Read the detailed description
Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come up in recent years. Robot-assisted therapy (RAT) is one of these new treatment approaches. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications. It is seen that robotic systems are very suitable for the patient to receive more intense and task-oriented motor training by integrating with other rehabilitation approaches. Considering the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term studies are needed. In this study, investigators aimed to investigate the effect of robotic hand therapy added to conventional rehabilitation on motor functions and quality of life in stroke patients. Patients will be evaluated pretreatment, posttreatment and 3 months later after treatment. Evaluation parameters consist of Brunnstrom Staging, Modified Ashworth Scale (MAS), Fugl Meyer Assessment of The Upper Extremity, Functional Independence Measure Scale (FIM) and ABILHAND Questionnaire, Stroke Impact Scale (SIS), Stroke-Specific Quality of Life Scale (SS-QOL) and SF-36 Quality of Life Questionnaire. We think that robot-assisted therapy will contribute to the improvement of hand functions and quality of life in stroke patients.
- Conditions
- Stroke, Robot Assisted Therapy, Robotic Rehabilitation
- Being tested
- Robot assisted therapy, Conventional Therapy Group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted therapyProcedure or surgery
In addition to the conventional treatment for 60 minutes in the RYT group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience
Conventional Therapy GroupProcedure or surgery
An exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) and 15 minutes of NMES was planned, accompanied by a physiotherapist experienced for at least 5 years in stroke rehabilitation, in the conventional therapy group.
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Therapy Group | Experimental | In addition to the conventional treatment for 60 minutes in the Robot asisted therapy (RAT) group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience. For the purpose of conventional therapy, an exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) accompanied by a physiotherapist experienced in stroke rehabilitation for at least 5 years, and neuromuscular therapy for the upper and lower extremities for 15 minutes.Electrical stimulation (NMES) application was planned. It was planned to apply a total of 60 sessions of treatment 5 days a week to both groups. They will be advised to continue the medical treatment they have been using during the treatment program. Receives: Procedure: Robot assisted therapy |
| Conventional Therapy Group | Active comparator | 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological studies were performed in the presence of a physiotherapist experienced in stroke rehabilitation for at least 5 years.An exercise program consisting of exercises (Brunstroom exercises) and 15 minutes of NMES were planned. It was planned to apply a total of 60 sessions of treatment 5 days a week to both groups. They will be advised to continue the medical treatment they have been using during the treatment program. Receives: Procedure: Conventional Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brunnstrom stage
Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient was defined as 6 stages. According to this staging low stage; stage 1 (flask, the stage without voluntary movement), the highest stage was determined as stage 6 (stage with isolated joint movement). Hand, upper and lower limbs in Brunnstrom staging extremities are evaluated separately.
Measured: 5 minutes
upper extremity spasticity assessment
It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.
Measured: 5 minutes
Fugl Meyer Upper Extremity Assessment Questionnaire wrist and hand assessment
The Fugl-Meyer Upper Extremity Motor Rating Scale was developed to quantitatively evaluate sensorimotor recovery after stroke.Based on Brunnstrom's stages of motor recovery
Measured: 15 minutes
ABILHAND Stroke Hand Function Questionnaire
The ABILHAND Hand Questionnaire was developed in 1998 to measure patient-perceived dexterity. It contains 23 questions about how difficult the patient has to do the activities. impossible (0 points), difficult (1 point), easly (2 points) options is marked. The total score is 46.
Measured: 15 minutes
Secondary outcomes (4)
Functional Independence Scale
It is a scale that evaluates the performance of individuals regarding activities of daily living. It consists of 18 items and evaluates the functions of individuals in 2 main sections: physical/motor function (13 items) and cognitive function (5 items). The items also include 6 subheadings (self-care, sphincter control, transfers, movement, communication, and social-perception).
Each item is scored between 1-7; 1 indicates full assistance and 7 indicates complete independence. The total score ranges between 18-126 (fully dependent-fully independent).
Measured: 20 minutes
Stroke Impact Survey
- The Stroke Impact Scale (SIS) is a stroke-specific measure of health status. It consists of a total of 59 items and 8 sections. The patient is asked to evaluate the difficulty experienced in completing each item in the last week on a five-point Likert scale. One point indicates that the patient could not complete the item, and five points indicate that he had no difficulty in completing it. It also includes a visual analog scale (0: No recovery, 100: Complete recovery) related to the perception of general recovery after stroke
Measured: 20 minutes
Stroke Specific Quality of Life Scale: SSQOL
The SSQOL is a stroke-specific, patient-centered quality of life measure. The SSQOL contains 49 items and consists of 12 areas; mobility, energy, upper extremity function, work/production, mood, self care, social roles, family roles, vision, language, thinking, and personality. Each area consists of at least 3 items, and each item is evaluated on a 5-point Likert scale, taking into account the last week.Higher scores reflect better function.
Measured: 30 minutes
short form 36
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100 Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Dec 2021
- Primary completion1 May 2023
- Study completion1 Jun 2023
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
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
- Investigators
- SEVDA ADAR, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601115
- Sponsor's protocol ID
- SASHR22
- Status last verified
- Jul 2023
- First submitted
- 18 Oct 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Robotic Hand Therapy and Conventional Therapy to Rehabilitation Outcomes in Stroke Patients
- ClinicalTrials.gov ID
- NCT05601115
- Acronym / sponsor ID
- SASHR22
- Conditions
- Stroke, Robot Assisted Therapy, Robotic Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Nov 2022 (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.
RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.The aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.
Detailed description
Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come up in recent years. Robot-assisted therapy (RAT) is one of these new treatment approaches. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications. It is seen that robotic systems are very suitable for the patient to receive more intense and task-oriented motor training by integrating with other rehabilitation approaches. Considering the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term studies are needed. In this study, investigators aimed to investigate the effect of robotic hand therapy added to conventional rehabilitation on motor functions and quality of life in stroke patients. Patients will be evaluated pretreatment, posttreatment and 3 months later after treatment. Evaluation parameters consist of Brunnstrom Staging, Modified Ashworth Scale (MAS), Fugl Meyer Assessment of The Upper Extremity, Functional Independence Measure Scale (FIM) and ABILHAND Questionnaire, Stroke Impact Scale (SIS), Stroke-Specific Quality of Life Scale (SS-QOL) and SF-36 Quality of Life Questionnaire. We think that robot-assisted therapy will contribute to the improvement of hand functions and quality of life in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Therapy Group | Experimental | Procedure: Robot assisted therapyIn addition to the conventional treatment for 60 minutes in the Robot asisted therapy (RAT) group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience. For the purpose of conventional therapy, an exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) accompanied by a physiotherapist experienced in stroke rehabilitation for at least 5 years, and neuromuscular therapy for the upper and lower extremities for 15 minutes.Electrical stimulation (NMES) application was planned. It was planned to apply a total of 60 sessions of treatment 5 days a week to both groups. They will be advised to continue the medical treatment they have been using during the treatment program. |
| Conventional Therapy Group | Active comparator | Procedure: Conventional Therapy Group45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological studies were performed in the presence of a physiotherapist experienced in stroke rehabilitation for at least 5 years.An exercise program consisting of exercises (Brunstroom exercises) and 15 minutes of NMES were planned. It was planned to apply a total of 60 sessions of treatment 5 days a week to both groups. They will be advised to continue the medical treatment they have been using during the treatment program. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral stroke
- Between 4 weeks and 6 months after stroke
- health status was suitable for rehabilitation
- who could understand commands with a mini mental test score of 15 and above
- who had Brunnstrom grade 3 and below (≤3).
Key exclusion criteria (10 listed)
- Patients with persistent upper extremity pain on the hemiplegic side (VAS>40)
- Patients with severe spasticity in the hand (MAS≥3)
- Patients with contractures in the hand
- Patients who had fractures or operations on the hemiplegic side in the last 6 months
- Patients who received botulinum toxin injection to the upper extremity in 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 |
|---|---|---|
| Robot assisted therapyIn addition to the conventional treatment for 60 minutes in the RYT group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience | Procedure or surgery | Robot Assisted Therapy Group |
| Conventional Therapy GroupAn exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) and 15 minutes of NMES was planned, accompanied by a physiotherapist experienced for at least 5 years in stroke rehabilitation, in the conventional therapy group. | Procedure or surgery | Conventional Therapy Group |
Primary outcome
Brunnstrom stage
Time frame: 5 minutes
Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient was defined as 6 stages. According to this staging low stage; stage 1 (flask, the stage without voluntary movement), the highest stage was determined as stage 6 (stage with isolated joint movement). Hand, upper and lower limbs in Brunnstrom staging extremities are evaluated separately.
upper extremity spasticity assessment
Time frame: 5 minutes
It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.
Fugl Meyer Upper Extremity Assessment Questionnaire wrist and hand assessment
Time frame: 15 minutes
The Fugl-Meyer Upper Extremity Motor Rating Scale was developed to quantitatively evaluate sensorimotor recovery after stroke.Based on Brunnstrom's stages of motor recovery
ABILHAND Stroke Hand Function Questionnaire
Time frame: 15 minutes
The ABILHAND Hand Questionnaire was developed in 1998 to measure patient-perceived dexterity. It contains 23 questions about how difficult the patient has to do the activities. impossible (0 points), difficult (1 point), easly (2 points) options is marked. The total score is 46.
4 secondary outcomes
Functional Independence Scale
Time frame: 20 minutes
Stroke Impact Survey
Time frame: 20 minutes
Stroke Specific Quality of Life Scale: SSQOL
Time frame: 30 minutes
short form 36
Time frame: 30 minutes
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 20 Jul 2023.
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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.
SEVDA ADAR principal investigator
Afyonkarahisar Health Sciences 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 Robot assisted therapy and Conventional Therapy Group in people with Stroke and Robot Assisted Therapy, run by Afyonkarahisar Health Sciences 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 6 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: finished, as of the sponsor's last update on 20 Jul 2023. 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?
Brunnstrom stage (time frame: 5 minutes). 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 20 Jul 2023.