StrokeNCT05559385
Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke
A study testing Robot-Assissted Therapy and Conventional Rehabilitation in people with Stroke, run by Emresenocak at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR). A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-Assissted Therapy and Conventional Rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 5 Aug 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-85 years and having had a stroke in the last six months,
- Mini-Mental State Assessment score >20,
- Able to sit safely,
- No neglect issue,
- Fugl-Meyer Upper Extremity Assessment score <58.
Who cannot join
- Modified Ashworth Scale >2,
- Severe reduction in visual acuity,
- Participation in another rehabilitation program,
- Subluxation or pain in the shoulder region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke
The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR).
A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).
Read the detailed description
Assessments:
- Demographic Data Form: The researchers created a form to include the information on age, gender, stroke onset date, lesion type, affected side, and dominant extremity.
- Fugl-Meyer Upper Extremity Assessment: This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients (18). It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. The affected upper extremities are assessed with the subject in a seated position.
- Wolf Motor Function Test: This test was created to evaluate the motor ability of the upper extremity (19). The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The total score is used for the functional ability of the patients. The two items of muscle strength evaluation were not used in this study.
- Trunk Impairment Scale: This scale evaluates static and dynamic sitting balance and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. The test-retest and inter-rater reliability coefficients of the scale have been shown to be 0.85-0.99 (21).
- Conditions
- Stroke
- Being tested
- Robot-Assissted Therapy, Conventional Rehabilitation
- Keywords
- Robotic Rehabilitation, Conventional Rehabilitation, Intensıve Trunk Rehabilitation, Motor Function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assissted TherapyDevice
Houston Bionics ExoRehab X brand/model device was used for improving the upper extremity in subacute stroke.
Conventional RehabilitationProcedure or surgery
It is an upper extremity rehabilitation program prepared in line with individual needs.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Rehabilitation Group | Experimental | The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward, and push-ups with a Swiss Ball. This group received a robotic rehabilitation program for the upper extremity with a Houston Bionics ExoRehab X brand/model device. This device has no motor force of repulsion or attraction. Patients initiate and maintain their movements during the exercise. The device supports the patient's active movement and allows extensive movement repetition.
Before starting robotic rehabilitation, the patient was seated upright on the platform. The games were projected onto a 43-inch television screen. The exercise program was planned to include upper extremity movements in all directions. Receives: Device: Robot-Assissted Therapy |
| Conventional Rehabilitation Group | Active comparator | The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. During this period, lower extremity rehabilitation was added if needed in addition to trunk rehabilitation. Exercises for the lower extremities were applied according to the patient's individual needs. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward and sideways, and push-ups with a Swiss Ball.
CR applied after the ITR program consisted of an individualized rehabilitation program for the upper extremities. These rehabilitation programs generally included activities for functional purposes (dressing, object manipulation, reaching, cup holding, range of motion, strengthening, weight-bearing, etc.). The treatment program was applied five days a week for six weeks, with the session duration limited to 60 minutes. Receives: Procedure: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Assessment:
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.
Measured: At the baseline
Fugl-Meyer Upper Extremity Assessment:
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.
Measured: At the end of the 6th week
Secondary outcomes (5)
Demographic Data Form
Demographic Characteristics
Measured: At the baseline
- Wolf Motor Function Test:
This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability.
Measured: At the baseline
- Wolf Motor Function Test:
This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability.
Measured: At the end of the 6th week
Trunk Impairment Scale
This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance.
Measured: At the baseline
Trunk Impairment Scale
This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance.
Measured: At the end of the 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start2 Jan 2022
- Primary completion17 Jun 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- A Randomized Controlled (One group received Robotic Rehabilitation, other group received conventional rehabilitation)
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emresenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emresenocak, Marmara University
- Investigators
- Aysel Yildiz Ozer, PhD, Study director, Marmara UniversityAdem Aktürk, PhD, Principal investigator, Gelişim UniversityElif Korkut, PhD, Principal investigator, Bağcılar Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559385
- Sponsor's protocol ID
- 09.2021.168
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Senocak E, Korkut E, Akturk A, Ozer AY. Is the robotic rehabilitation that is added to intensive body rehabilitation effective for maximization of upper extremity motor recovery following a stroke? A randomized controlled study. Neurol Sci. 2023 Aug;44(8):2835-2843. doi: 10.1007/s10072-023-06739-3. Epub 2023 Mar 10.
PubMed 36897464
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke
- ClinicalTrials.gov ID
- NCT05559385
- Acronym / sponsor ID
- 09.2021.168
- Conditions
- Stroke
- Keywords
- Robotic Rehabilitation, Conventional Rehabilitation, Intensıve Trunk Rehabilitation, Motor Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- EmresenocakUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 29 Sep 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.
The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR).
A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).
Detailed description
Assessments:
- Demographic Data Form: The researchers created a form to include the information on age, gender, stroke onset date, lesion type, affected side, and dominant extremity.
- Fugl-Meyer Upper Extremity Assessment: This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients (18). It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. The affected upper extremities are assessed with the subject in a seated position.
- Wolf Motor Function Test: This test was created to evaluate the motor ability of the upper extremity (19). The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The total score is used for the functional ability of the patients. The two items of muscle strength evaluation were not used in this study.
- Trunk Impairment Scale: This scale evaluates static and dynamic sitting balance and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. The test-retest and inter-rater reliability coefficients of the scale have been shown to be 0.85-0.99 (21).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled (One group received Robotic Rehabilitation, other group received conventional rehabilitation)
| Arm | Type | Receives |
|---|---|---|
| Robotic Rehabilitation Group | Experimental | Device: Robot-Assissted TherapyThe standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward, and push-ups with a Swiss Ball. This group received a robotic rehabilitation program for the upper extremity with a Houston Bionics ExoRehab X brand/model device. This device has no motor force of repulsion or attraction. Patients initiate and maintain their movements during the exercise. The device supports the patient's active movement and allows extensive movement repetition. Before starting robotic rehabilitation, the patient was seated upright on the platform. The games were projected onto a 43-inch television screen. The exercise program was planned to include upper extremity movements in all directions. |
| Conventional Rehabilitation Group | Active comparator | Procedure: Conventional RehabilitationThe standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. During this period, lower extremity rehabilitation was added if needed in addition to trunk rehabilitation. Exercises for the lower extremities were applied according to the patient's individual needs. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward and sideways, and push-ups with a Swiss Ball. CR applied after the ITR program consisted of an individualized rehabilitation program for the upper extremities. These rehabilitation programs generally included activities for functional purposes (dressing, object manipulation, reaching, cup holding, range of motion, strengthening, weight-bearing, etc.). The treatment program was applied five days a week for six weeks, with the session duration limited to 60 minutes. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-85 years and having had a stroke in the last six months,
- Mini-Mental State Assessment score >20,
- Able to sit safely,
- No neglect issue,
- Fugl-Meyer Upper Extremity Assessment score <58.
Key exclusion criteria (4 listed)
- Modified Ashworth Scale >2,
- Severe reduction in visual acuity,
- Participation in another rehabilitation program,
- Subluxation or pain in the shoulder region.
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-Assissted TherapyHouston Bionics ExoRehab X brand/model device was used for improving the upper extremity in subacute stroke. | Device | Robotic Rehabilitation Group |
| Conventional RehabilitationIt is an upper extremity rehabilitation program prepared in line with individual needs. | Procedure or surgery | Conventional Rehabilitation Group |
Primary outcome
Fugl-Meyer Upper Extremity Assessment:
Time frame: At the baseline
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.
Fugl-Meyer Upper Extremity Assessment:
Time frame: At the end of the 6th week
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.
5 secondary outcomes
Demographic Data Form
Time frame: At the baseline
- Wolf Motor Function Test:
Time frame: At the baseline
- Wolf Motor Function Test:
Time frame: At the end of the 6th week
Trunk Impairment Scale
Time frame: At the baseline
Trunk Impairment Scale
Time frame: At the end of the 6th week
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 3 Oct 2022.
- Derived from this study: PubMed 36897464Senocak E, Korkut E, Akturk A, Ozer AY. Is the robotic rehabilitation that is added to intensive body rehabilitation effective for maximization of upper extremity motor recovery following a stroke? A randomized controlled study. Neurol Sci. 2023 Aug;44(8):2835-2843. doi: 10.1007/s10072-023-06739-3. Epub 2023 Mar 10.
- Individual participant dataSharing planned: Undecided
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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.
Aysel Yildiz Ozer, PhD study director
Marmara University
Adem Aktürk, PhD principal investigator
Gelişim University
Elif Korkut, PhD principal investigator
Bağcılar Education and Research Hospital
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-Assissted Therapy and Conventional Rehabilitation in people with Stroke, run by Emresenocak 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 5 inclusion and 4 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 3 Oct 2022. 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 Assessment: (time frame: At the baseline). 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?
On the ClinicalTrials.gov record for NCT05559385, which also lists 1 linked publication.
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 3 Oct 2022.