StrokeNCT05958628
The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients
A study testing Conventional physiotherapy and Robotic Hand Exoskeleton System in people with Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effects of the robotic hand exoskeleton, on the spasticity, motor control skills, level of daily living activity, quality of life and functional independence of stroke patients. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional physiotherapy and Robotic Hand Exoskeleton System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2023to 30 Nov 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with stroke by a neurologist
- At least 3 months have passed after the stroke
- Mini Mental State Examination score of at least 24
- To be able to maintain sitting balance during working with the robot,
- Having full range of motion in the metacarpophalangeal (MCP), proximal interphalangeal (PIF) and distal interphalangeal (DIF) joints,
- Spasticity in finger flexor and extensor muscles ≤ 3 according to the Modified Ashworth Scale (MAS)
- Being between the ages of 35-85
Who cannot join
- Other neurological or orthopedic problems that may affect upper extremity function,
- Cardiovascular vulnerability (severe uncontrolled hypertension, severe coronary artery disease, unstable angina)
- Behavioral and cognitive conditions that affect treatment and make compliance difficult
- Having botulinum toxin procedure in the last 6 months
- Cardiac pacemakers
- Those with skin ulcers
- Pregnancy
- History of metastatic cancer
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to investigate the effects of the robotic hand exoskeleton, on the spasticity, motor control skills, level of daily living activity, quality of life and functional independence of stroke patients.
Read the detailed description
Stroke is a condition that occurs as a result of an ischemic or hemorrhagic intracranial vascular event, is the third leading cause of death in the world and can lead to disability. Depending on the localization of brain damage after stroke, it is possible to talk about different prognoses and therefore different functional losses in the lower extremities, upper extremities and hand and wrist.
Today, various neurophysiological approaches, exercise strategies, electrotherapy modalities and assistive devices are used in the rehabilitation program suitable for the patient after stroke. In addition to these, robot-assisted therapy is gaining a place as an innovative approach in stroke rehabilitation with the developments in technology. Robot-assisted therapy is thought to both facilitate and intensify treatment after stroke and increase motor development.
The normal functions of the hand, which has many abilities and a complex structure, is extremely important to lead a free and active life. When the literature is examined, the success rate in the recovery of skills and functional recovery of the hand in stroke rehabilitation is low compared to the lower extremity and shoulder joint. More interventions are needed to increase the functional recovery of the hand. Studies should be conducted on robot-assisted treatment methods that allow active and passive exercises in the hand after stroke and contribute to neuroplasticity with an intensified and standardized program.
Our aim in this study is to investigate the efficacy of the Robotic Hand Exoskeleton System developed at Marmara University in order to reduce the physiotherapy process and increase the responses of patients who have partially lost their hand functions due to stroke and need rehabilitation in stroke patients.
- Conditions
- Stroke
- Being tested
- Conventional physiotherapy, Robotic Hand Exoskeleton System
- Keywords
- Stroke, Hemiplegia, Exoskeleton Device, Muscle Spasticity, Quality of life
- Medical subject headings
- Stroke, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
The treatment program was designed in line with the patients' compliance, functional capacities and rehabilitation goals as neurodevelopmental therapy based on the ability to adapt to change, reorganization and healing in the brain by focusing on neuroplasticity from neurodevelopmental treatment approaches; Proprioceptive neuromuscular facilitation techniques to increase selective and voluntary movement; functional exercises to increase motor control skills, stretching exercises for spasticity and neuromuscular electrical stimulation.
The control group received conventional physiotherapy exercises for 45 minutes and neuromuscular electrical stimulation for 15 minutes.
Robotic Hand Exoskeleton SystemOther
In the treatment applications with the robotic hand exoskeleton system, which is designed to accelerate the healing process of patients in need of hand rehabilitation, to gain motor skills, to provide strength training and to increase participation in treatment, the patient will be asked to allow the system to move the hand at adjusted angles for 10 minutes and to accompany this movement. In the applications, while the patient is sitting comfortably and safely, the patient will be asked to place the stroke-affected hand into the system. The hand of patients who may have difficulty due to the functional status of the upper extremity and the severity of spasticity will be placed with the help of the physiotherapist. The physiotherapist will be with the patient throughout the application.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Participants in this group will receive a conventional physiotherapy program 3 times a week for 5 weeks, each session lasting 1 hour. Receives: Other: Conventional physiotherapy |
| Intervention group | Experimental | Participants in this group will receive Robotic Hand Exoskeleton System for 10 minutes in addition to 50 minutes of conventional physiotherapy 3 times a week for 5 weeks. Receives: Other: Conventional physiotherapy; Other: Robotic Hand Exoskeleton System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frenchay Arm Test
It is a scale that evaluates the motor control skills and functions of the upper extremities of patients in a practical way and takes less than 3 minutes to perform. The patient is asked to perform 5 tasks based on activities of daily living in a sitting position with hands on the table. The maximum score on the scale is 5, with 1 point for each successful task. (The tasks the patient is asked to do are; Fixing the ruler, Holding a cylinder, Lifting the glass, Attaching the latch to the bar, Combing hair)
Measured: 5 weeks
Secondary outcomes (3)
modified ashworth scale
The modified Ashworth scale is designed to measure the resistance encountered when moving the limb passively at full range of motion. A value of 0 indicates normal muscle tone and 4 indicates the presence of intense spasticity.
Measured: 5 weeks
Upper Limb Motor Activity Diary-28
The Upper Extremity Motor Activity Diary-28 is a scale consisting of 28 questions that measure the amount of use of the affected upper extremity in daily activities and the quality of the activity when used, and each question is scored between 0-5. Self-care activities, some housework and some activities that can be done in community life are questioned.
Measured: 5 weeks
Stroke impact scale version 3.0
It was developed in 1999 to assess the quality of life and functional independence of post-stroke patients and consists of 59 questions with 8 sub-headings: strength, memory and memory, emotion, communication, activity of daily living, mobility, hand function, social participation. All questions are used to assess the difficulties experienced by the patient in the last week. The evaluation is based on 5 points. In addition to 59 questions in 8 sub-sections, it also includes a visual analog scale (0: No improvement, 100: Complete recovery) in which the patient's perception of global recovery after stroke is evaluated with 0-100 points. The score of all subcategories is summed, and the higher the total score obtained from the scale, the better the quality of life of the patients.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start7 Aug 2023
- Primary completion17 Nov 2023
- Study completion30 Nov 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.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Model description
- Two groups; one group will receive conventional physiotherapy and one group will be operated with robotic hand exoskeleton system in addition to conventional physiotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ozturk, Marmara University
- Investigators
- Fatma Öztürk, Msc, Principal investigator, Marmara UniversityGönül Acar, assoc.prof, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958628
- Sponsor's protocol ID
- MarmaraU-FTR-FO-01
- Status last verified
- Apr 2024
- First submitted
- 16 Jul 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients
- ClinicalTrials.gov ID
- NCT05958628
- Acronym / sponsor ID
- MarmaraU-FTR-FO-01
- Conditions
- Stroke
- Keywords
- Stroke, Hemiplegia, Exoskeleton Device, Muscle Spasticity, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 24 Jul 2023 (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 aim of our study is to investigate the effects of the robotic hand exoskeleton, on the spasticity, motor control skills, level of daily living activity, quality of life and functional independence of stroke patients.
Detailed description
Stroke is a condition that occurs as a result of an ischemic or hemorrhagic intracranial vascular event, is the third leading cause of death in the world and can lead to disability. Depending on the localization of brain damage after stroke, it is possible to talk about different prognoses and therefore different functional losses in the lower extremities, upper extremities and hand and wrist.
Today, various neurophysiological approaches, exercise strategies, electrotherapy modalities and assistive devices are used in the rehabilitation program suitable for the patient after stroke. In addition to these, robot-assisted therapy is gaining a place as an innovative approach in stroke rehabilitation with the developments in technology. Robot-assisted therapy is thought to both facilitate and intensify treatment after stroke and increase motor development.
The normal functions of the hand, which has many abilities and a complex structure, is extremely important to lead a free and active life. When the literature is examined, the success rate in the recovery of skills and functional recovery of the hand in stroke rehabilitation is low compared to the lower extremity and shoulder joint. More interventions are needed to increase the functional recovery of the hand. Studies should be conducted on robot-assisted treatment methods that allow active and passive exercises in the hand after stroke and contribute to neuroplasticity with an intensified and standardized program.
Our aim in this study is to investigate the efficacy of the Robotic Hand Exoskeleton System developed at Marmara University in order to reduce the physiotherapy process and increase the responses of patients who have partially lost their hand functions due to stroke and need rehabilitation in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups; one group will receive conventional physiotherapy and one group will be operated with robotic hand exoskeleton system in addition to conventional physiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Conventional physiotherapyParticipants in this group will receive a conventional physiotherapy program 3 times a week for 5 weeks, each session lasting 1 hour. |
| Intervention group | Experimental | Other: Conventional physiotherapy, Other: Robotic Hand Exoskeleton SystemParticipants in this group will receive Robotic Hand Exoskeleton System for 10 minutes in addition to 50 minutes of conventional physiotherapy 3 times a week for 5 weeks. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being diagnosed with stroke by a neurologist
- At least 3 months have passed after the stroke
- Mini Mental State Examination score of at least 24
- To be able to maintain sitting balance during working with the robot,
- Having full range of motion in the metacarpophalangeal (MCP), proximal interphalangeal (PIF) and distal interphalangeal (DIF) joints,
Key exclusion criteria (8 listed)
- Other neurological or orthopedic problems that may affect upper extremity function,
- Cardiovascular vulnerability (severe uncontrolled hypertension, severe coronary artery disease, unstable angina)
- Behavioral and cognitive conditions that affect treatment and make compliance difficult
- Having botulinum toxin procedure in the last 6 months
- Cardiac pacemakers
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 |
|---|---|---|
| Conventional physiotherapyThe treatment program was designed in line with the patients' compliance, functional capacities and rehabilitation goals as neurodevelopmental therapy based on the ability to adapt to change, reorganization and healing in the brain by focusing on neuroplasticity from neurodevelopmental treatment approaches; Proprioceptive neuromuscular facilitation techniques to increase selective and voluntary movement; functional exercises to increase motor control skills, stretching exercises for spasticity and neuromuscular electrical stimulation. The control group received conventional physiotherapy exercises for 45 minutes and neuromuscular electrical stimulation for 15 minutes. | Other | Control group, Intervention group |
| Robotic Hand Exoskeleton SystemIn the treatment applications with the robotic hand exoskeleton system, which is designed to accelerate the healing process of patients in need of hand rehabilitation, to gain motor skills, to provide strength training and to increase participation in treatment, the patient will be asked to allow the system to move the hand at adjusted angles for 10 minutes and to accompany this movement. In the applications, while the patient is sitting comfortably and safely, the patient will be asked to place the stroke-affected hand into the system. The hand of patients who may have difficulty due to the functional status of the upper extremity and the severity of spasticity will be placed with the help of the physiotherapist. The physiotherapist will be with the patient throughout the application. | Other | Intervention group |
Primary outcome
Frenchay Arm Test
Time frame: 5 weeks
It is a scale that evaluates the motor control skills and functions of the upper extremities of patients in a practical way and takes less than 3 minutes to perform. The patient is asked to perform 5 tasks based on activities of daily living in a sitting position with hands on the table. The maximum score on the scale is 5, with 1 point for each successful task. (The tasks the patient is asked to do are; Fixing the ruler, Holding a cylinder, Lifting the glass, Attaching the latch to the bar, Combing hair)
3 secondary outcomes
modified ashworth scale
Time frame: 5 weeks
Upper Limb Motor Activity Diary-28
Time frame: 5 weeks
Stroke impact scale version 3.0
Time frame: 5 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 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Fatma Öztürk, Msc principal investigator
Marmara University
Gönül Acar, assoc.prof study director
Marmara 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 Conventional physiotherapy and Robotic Hand Exoskeleton System in people with Stroke, run by Marmara 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 8 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 1 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?
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?
Frenchay Arm Test (time frame: 5 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 1 May 2024.