StrokeNCT06306313
Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke
A study testing ReoGo and Conventional Physiotherapy in people with Stroke and Upper Extremity Paresis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- ReoGo and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2024to 14 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having had a single stroke
- Having had at least 6 months since the stroke
- Having hemiparesis/hemiplegia following the stroke
- Having mental health sufficient to meet all evaluation and treatment procedures in the study
Who cannot join
- Having a history of disease other than stroke that affects the use of the upper extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions and Activities of Daily Living in Chronic Stroke Patients
The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.
It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.
In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- ReoGo, Conventional Physiotherapy
- Keywords
- Robotic Rehabilitation, Chronic Stroke, Upper Limb, Activities of Daily Living
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReoGoDevice
ReoGo is a fixed arm rehabilitation exoskeleton that comes on a small and compact wheeled platform. The end-effector extension is capable of producing a wide range or repeatable movements in 3D space. ReoGo can be used by both adults and children. It is an arm rehabilitation exoskeleton with a fixed base. Its design allows limited controlled movements of the shoulder as well as the elbow and wrist.
Conventional PhysiotherapyOther
Physiotherapy protocols will be created with traditional physiotherapy practices such as neurodevelopmental techniques based on muscle strengthening and task-oriented exercises. Protocols in general terms; It will include passive and active joint range of motion exercises, stretching exercises, stimulation and facilitation techniques, strengthening exercises, fine motor skills and functional task training for daily living activities. Protocols will be tailored to each patient's level of motor impairment and functional needs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Conventional physiotherapy will be applied in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition, robot-assisted therapy will be applied with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. Evaluations will be made at the beginning and end of the treatment process. Receives: Device: ReoGo; Other: Conventional Physiotherapy |
| Control Group | Active comparator | The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. Evaluations will be made at the beginning and end of the treatment process. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Upper Extremity Evaluation Scale
It is a scale based on measuring performance and is frequently recommended for use especially in stroke patients. Test; It consists of subsections: reflex activity, flexor and extensor synergy, combined synergistic movements, non-synergistic movements, normal reflex activity, wrist and hand evaluation, coordination and speed evaluation. It consists of 33 items in total and each item is scored between 0 and 2 points (0: cannot do, 1: partially can, 2: completely can). Total score is 66. It is easy to apply, does not require a lot of equipment, items found at home are sufficient and takes about 30 minutes.
Measured: Through study completion, an average of 3 months
Functional Independence Scale
It is used to evaluate the independence of patients in daily living activities. It has 13 items consisting of 4 subcategories to evaluate motor functional limitation, including self-care, sphincter control, transfer and displacement. To evaluate cognitive functional limitation, it has 5 items consisting of 2 subcategories including communication and social perception. It is a scale divided into 6 categories and consisting of 18 items in total. Each item is rated on a 7-point scale. A score of 7 indicates complete independence, while a score of 1 indicates maximum dependence. The lowest score that can be obtained from the scale is 18 and the highest score is 126. As the score obtained from the scale increases, the patient's level of independence increases.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start7 Mar 2024
- Primary completion7 Aug 2024
- Study completion14 Oct 2024
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 Pamukkale 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Tekin, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306313
- Sponsor's protocol ID
- ReoGo
- Status last verified
- Nov 2024
- First submitted
- 28 Feb 2024
- Last updated
- 5 Nov 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions and Activities of Daily Living in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06306313
- Acronym / sponsor ID
- ReoGo
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- Robotic Rehabilitation, Chronic Stroke, Upper Limb, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 12 Mar 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.
The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.
It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.
In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: ReoGo, Other: Conventional PhysiotherapyConventional physiotherapy will be applied in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition, robot-assisted therapy will be applied with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. Evaluations will be made at the beginning and end of the treatment process. |
| Control Group | Active comparator | Other: Conventional PhysiotherapyThe control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. Evaluations will be made at the beginning and end of the treatment process. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having had a single stroke
- Having had at least 6 months since the stroke
- Having hemiparesis/hemiplegia following the stroke
- Having mental health sufficient to meet all evaluation and treatment procedures in the study
Key exclusion criteria (1 listed)
- Having a history of disease other than stroke that affects the use of the upper extremity
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 |
|---|---|---|
| ReoGoReoGo is a fixed arm rehabilitation exoskeleton that comes on a small and compact wheeled platform. The end-effector extension is capable of producing a wide range or repeatable movements in 3D space. ReoGo can be used by both adults and children. It is an arm rehabilitation exoskeleton with a fixed base. Its design allows limited controlled movements of the shoulder as well as the elbow and wrist. | Device | Experimental |
| Conventional PhysiotherapyPhysiotherapy protocols will be created with traditional physiotherapy practices such as neurodevelopmental techniques based on muscle strengthening and task-oriented exercises. Protocols in general terms; It will include passive and active joint range of motion exercises, stretching exercises, stimulation and facilitation techniques, strengthening exercises, fine motor skills and functional task training for daily living activities. Protocols will be tailored to each patient's level of motor impairment and functional needs. | Other | Control Group, Experimental |
Primary outcome
Fugl Meyer Upper Extremity Evaluation Scale
Time frame: Through study completion, an average of 3 months
It is a scale based on measuring performance and is frequently recommended for use especially in stroke patients. Test; It consists of subsections: reflex activity, flexor and extensor synergy, combined synergistic movements, non-synergistic movements, normal reflex activity, wrist and hand evaluation, coordination and speed evaluation. It consists of 33 items in total and each item is scored between 0 and 2 points (0: cannot do, 1: partially can, 2: completely can). Total score is 66. It is easy to apply, does not require a lot of equipment, items found at home are sufficient and takes about 30 minutes.
Functional Independence Scale
Time frame: Through study completion, an average of 3 months
It is used to evaluate the independence of patients in daily living activities. It has 13 items consisting of 4 subcategories to evaluate motor functional limitation, including self-care, sphincter control, transfer and displacement. To evaluate cognitive functional limitation, it has 5 items consisting of 2 subcategories including communication and social perception. It is a scale divided into 6 categories and consisting of 18 items in total. Each item is rated on a 7-point scale. A score of 7 indicates complete independence, while a score of 1 indicates maximum dependence. The lowest score that can be obtained from the scale is 18 and the highest score is 126. As the score obtained from the scale increases, the patient's level of independence increases.
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 5 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReoGo and Conventional Physiotherapy in people with Stroke and Upper Extremity Paresis, run by Pamukkale 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 4 inclusion and 1 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 5 Nov 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?
Fugl Meyer Upper Extremity Evaluation Scale (time frame: Through study completion, an average of 3 months). The study lists 2 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 5 Nov 2024.