StrokeNCT03392493
Robot-assisted Hand Rehabilitation for Patients With Stroke
A study testing Robot-assisted hand rehabilitation and Standard treatment in people with Stroke, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke rehabilitation. Although the treatment effects were supported in studies, there are still limitations in clinical intervention. The study will use the robot-assisted hand rehabilitation with a Gloreha device. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-assisted hand rehabilitation and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2018to 30 Jun 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke with hemiplegia
- Chronicity > 3 months
- Could understand the instructions
- Brunnstrom stageⅡ-Ⅴ
- Sensory impairment (Revision of the Nottingham Sensory Assessment-Tatile< 2; Kinaesthetic < 3)
- Modified Ashworth Scale < 3
Who cannot join
- Age younger than 20 and older than75 years
- Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
- Individuals with other medical symptoms that can affect movement
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Taipei
About this study
Official title: The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke rehabilitation. Although the treatment effects were supported in studies, there are still limitations in clinical intervention. The study will use the robot-assisted hand rehabilitation with a Gloreha device. Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA), Modified Barthel Index. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
Read the detailed description
Many stroke survivors suffered problems with the upper extremity, such as paresis, synergy movement, hypertonicity, jag movement, sensory deficit. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg,work, driving). For individuals with more severe paresis, the potential for recovery of upper extremity function is greatly reduced. Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility compared with dose-matched conventional upper limb exercise therapies. Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on sensory, motor, and ADL ability for patients with stroke.
Materials and Methods: Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA) for hand evaluations, Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
- Conditions
- Stroke
- Being tested
- Robot-assisted hand rehabilitation, Standard treatment
- Keywords
- Stroke, Robotic rehabilitation, Hand function, Activities of Daily Living
- 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 hand rehabilitationBehavioural
Robot-assisted hand rehabilitation: 20 minute of worm-up exercise and 40 minute of robot-assisted hand exercise. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task and robot-assisted task.
Standard treatmentBehavioural
Standard treatment only group: 60 min standard treatment. 20 minute of worm-up exercise and 40 minute of traditional occupational therapy. Traditional occupational therapy include spasticity-reducing activity, bilateral hands activity and hand training task.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week) Receives: Behavioral: Robot-assisted hand rehabilitation; Behavioral: Standard treatment |
| Group B | Active comparator | In the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week) Receives: Behavioral: Robot-assisted hand rehabilitation; Behavioral: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment：Upper Limb section
Upper Limb motor function
Measured: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary outcomes (6)
Box and block test
Upper Limb motor function
Measured: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus
Grip strength
Measured: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Dynanometer
Grip strength
Measured: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Semmes-Weinstein hand monofilament
Light touch
Measured: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Revision of the Nottingham Sensory Assessment
Proprioception
Measured: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Modified barthel index
Activity of daily live ability
Measured: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)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
- Crossover
- Model description
- AB or BA
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jui chi Lin, master, Study chair, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392493
- Sponsor's protocol ID
- TMU-JIRB N201704068
- Status last verified
- Jun 2018
- First submitted
- 24 Aug 2017
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hatano S. Experience from a multicentre stroke register: a preliminary report. Bull World Health Organ. 1976;54(5):541-53.
PubMed 1088404Carod-Artal J, Egido JA, Gonzalez JL, Varela de Seijas E. Quality of life among stroke survivors evaluated 1 year after stroke: experience of a stroke unit. Stroke. 2000 Dec;31(12):2995-3000. doi: 10.1161/01.str.31.12.2995.
PubMed 11108762Chiu L, Shyu WC, Liu YH. Comparisons of the cost-effectiveness among hospital chronic care, nursing home placement, home nursing care and family care for severe stroke patients. J Adv Nurs. 2001 Feb;33(3):380-6. doi: 10.1046/j.1365-2648.2001.01703.x.
PubMed 11251725Nordin N, Xie SQ, Wunsche B. Assessment of movement quality in robot- assisted upper limb rehabilitation after stroke: a review. J Neuroeng Rehabil. 2014 Sep 12;11:137. doi: 10.1186/1743-0003-11-137.
PubMed 25217124Jang SH. The recovery of walking in stroke patients: a review. Int J Rehabil Res. 2010 Dec;33(4):285-9. doi: 10.1097/MRR.0b013e32833f0500.
PubMed 20805757Kopp B, Kunkel A, Muhlnickel W, Villringer K, Taub E, Flor H. Plasticity in the motor system related to therapy-induced improvement of movement after stroke. Neuroreport. 1999 Mar 17;10(4):807-10. doi: 10.1097/00001756-199903170-00026.
PubMed 10208552Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
PubMed 25012864Correction to: Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e78. doi: 10.1161/STR.0000000000000120. No abstract available.
PubMed 28115727Susanto EA, Tong RK, Ockenfeld C, Ho NS. Efficacy of robot-assisted fingers training in chronic stroke survivors: a pilot randomized-controlled trial. J Neuroeng Rehabil. 2015 Apr 25;12:42. doi: 10.1186/s12984-015-0033-5.
PubMed 25906983Sivan M, O'Connor RJ, Makower S, Levesley M, Bhakta B. Systematic review of outcome measures used in the evaluation of robot-assisted upper limb exercise in stroke. J Rehabil Med. 2011 Feb;43(3):181-9. doi: 10.2340/16501977-0674.
PubMed 21305232Varalta V, Picelli A, Fonte C, Montemezzi G, La Marchina E, Smania N. Effects of contralesional robot-assisted hand training in patients with unilateral spatial neglect following stroke: a case series study. J Neuroeng Rehabil. 2014 Dec 5;11:160. doi: 10.1186/1743-0003-11-160.
PubMed 25476507Sgaggio, E., Joint and functional benefits of a robotic glove for post-stroke patients. publication pending, 2015.
Pětioký, J. Robot-assisted therapy integrated with virtual reality for rehabilitation of hand function after stroke: a clinical case study. in the 20th ESPRM Congress 2016.
Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.
PubMed 27056250Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.
PubMed 22696362
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
- ClinicalTrials.gov ID
- NCT03392493
- Acronym / sponsor ID
- TMU-JIRB N201704068
- Conditions
- Stroke
- Keywords
- Stroke, Robotic rehabilitation, Hand function, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Jan 2018 (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.
Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke rehabilitation. Although the treatment effects were supported in studies, there are still limitations in clinical intervention. The study will use the robot-assisted hand rehabilitation with a Gloreha device. Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA), Modified Barthel Index. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
Detailed description
Many stroke survivors suffered problems with the upper extremity, such as paresis, synergy movement, hypertonicity, jag movement, sensory deficit. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg,work, driving). For individuals with more severe paresis, the potential for recovery of upper extremity function is greatly reduced. Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility compared with dose-matched conventional upper limb exercise therapies. Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on sensory, motor, and ADL ability for patients with stroke.
Materials and Methods: Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA) for hand evaluations, Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- AB or BA
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Robot-assisted hand rehabilitation, Behavioral: Standard treatmentIn the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week) |
| Group B | Active comparator | Behavioral: Robot-assisted hand rehabilitation, Behavioral: Standard treatmentIn the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First stroke with hemiplegia
- Chronicity > 3 months
- Could understand the instructions
- Brunnstrom stageⅡ-Ⅴ
- Sensory impairment (Revision of the Nottingham Sensory Assessment-Tatile< 2; Kinaesthetic < 3)
Key exclusion criteria (3 listed)
- Age younger than 20 and older than75 years
- Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
- Individuals with other medical symptoms that can affect movement
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 hand rehabilitationRobot-assisted hand rehabilitation: 20 minute of worm-up exercise and 40 minute of robot-assisted hand exercise. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task and robot-assisted task. | Behavioural | Group A, Group B |
| Standard treatmentStandard treatment only group: 60 min standard treatment. 20 minute of worm-up exercise and 40 minute of traditional occupational therapy. Traditional occupational therapy include spasticity-reducing activity, bilateral hands activity and hand training task. | Behavioural | Group A, Group B |
Primary outcome
Fugl-Meyer Assessment：Upper Limb section
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Upper Limb motor function
6 secondary outcomes
Box and block test
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Dynanometer
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Semmes-Weinstein hand monofilament
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Revision of the Nottingham Sensory Assessment
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Modified barthel index
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
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 Dec 2018.
- Background: PubMed 1088404Hatano S. Experience from a multicentre stroke register: a preliminary report. Bull World Health Organ. 1976;54(5):541-53.
- Background: PubMed 11108762Carod-Artal J, Egido JA, Gonzalez JL, Varela de Seijas E. Quality of life among stroke survivors evaluated 1 year after stroke: experience of a stroke unit. Stroke. 2000 Dec;31(12):2995-3000. doi: 10.1161/01.str.31.12.2995.
- Background: PubMed 11251725Chiu L, Shyu WC, Liu YH. Comparisons of the cost-effectiveness among hospital chronic care, nursing home placement, home nursing care and family care for severe stroke patients. J Adv Nurs. 2001 Feb;33(3):380-6. doi: 10.1046/j.1365-2648.2001.01703.x.
- Background: PubMed 25217124Nordin N, Xie SQ, Wunsche B. Assessment of movement quality in robot- assisted upper limb rehabilitation after stroke: a review. J Neuroeng Rehabil. 2014 Sep 12;11:137. doi: 10.1186/1743-0003-11-137.
- Background: PubMed 20805757Jang SH. The recovery of walking in stroke patients: a review. Int J Rehabil Res. 2010 Dec;33(4):285-9. doi: 10.1097/MRR.0b013e32833f0500.
- Background: PubMed 10208552Kopp B, Kunkel A, Muhlnickel W, Villringer K, Taub E, Flor H. Plasticity in the motor system related to therapy-induced improvement of movement after stroke. Neuroreport. 1999 Mar 17;10(4):807-10. doi: 10.1097/00001756-199903170-00026.
- Background: PubMed 25012864Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
- Background: PubMed 28115727Correction to: Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e78. doi: 10.1161/STR.0000000000000120. No abstract available.
- Background: PubMed 25906983Susanto EA, Tong RK, Ockenfeld C, Ho NS. Efficacy of robot-assisted fingers training in chronic stroke survivors: a pilot randomized-controlled trial. J Neuroeng Rehabil. 2015 Apr 25;12:42. doi: 10.1186/s12984-015-0033-5.
- Background: PubMed 21305232Sivan M, O'Connor RJ, Makower S, Levesley M, Bhakta B. Systematic review of outcome measures used in the evaluation of robot-assisted upper limb exercise in stroke. J Rehabil Med. 2011 Feb;43(3):181-9. doi: 10.2340/16501977-0674.
- Background: PubMed 25476507Varalta V, Picelli A, Fonte C, Montemezzi G, La Marchina E, Smania N. Effects of contralesional robot-assisted hand training in patients with unilateral spatial neglect following stroke: a case series study. J Neuroeng Rehabil. 2014 Dec 5;11:160. doi: 10.1186/1743-0003-11-160.
- BackgroundSgaggio, E., Joint and functional benefits of a robotic glove for post-stroke patients. publication pending, 2015.
- 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.
Jui chi Lin, master study chair
Taipei Medical University, Taiwan, R.O.C.
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 hand rehabilitation and Standard treatment in people with Stroke, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 3 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 Dec 2018. 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 Taiwan. 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 Assessment：Upper Limb section (time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month). 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 NCT03392493, which also lists 54 linked publications.
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 Dec 2018.