StrokeNCT03841695
The Therapeutic Effect of the Hand Robot on Stroke Patients Upper-lime Rehabilitation of Stroke Patients
A study testing RMTC finger-hand robot (Mirror Hand) and Conventional OT in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
In the present study, the RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The participants will be randomized assigned to treatment group (TG, robot assisted treatment) and control group (CG, conventional treatment). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- RMTC finger-hand robot (Mirror Hand) and Conventional OT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Dec 2018to 30 Apr 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Modified Ashworth Scale, MAS≦2
- Brunnstrom Recovery Stage of Arm≧2
- Mini-Mental State Examination; MMSE≧24
- aged from 20-90 years
- first stroke ≧1 month
Who cannot join
- poor cognitive ability (such as moderate to severe dementia, etc.) or mental illness (such as convulsions)
- wrist musculoskeletal system disease (such as fractures, tendon rupture, etc.) can not withstand external forces
- skin disorders (such as pressure sores, trauma, cellulitis, etc.)
- cerebellar stroke
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital at Taoyuan
Taoyuan City, Taoyuan, 333
About this study
Official title: The Therapeutic Effect of the Rehabotics Medical Technology Corporation (RMTC) Finger-hand Robot on Upper-limb Rehabilitation of Stroke Patients
In the present study, the RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The participants will be randomized assigned to treatment group (TG, robot assisted treatment) and control group (CG, conventional treatment). In the experimental group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box \& block test、Brunnstrom recovery Stage, and motor activity log (MAL).
Read the detailed description
Clinical reports indicated the functional recovery of the distal part of upper limb in stroke patient needs time period longer than other body parts, and there is a limitation in the efficiency of conventional treatment on the distal part of upper limb. Robot assisted rehabilitation is a novel application in treatment. Rehabilitation robot is able to assist patients move the affected side through external power to achieve a repeated exercising and further evoke the motor function. In the present study, the wearable RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The patient (post stroke>1 month) age from 20-90 years old with Modified Ashworth Scale ≦2, Brunnstrom Recovery Stage of Arm ≧ 2, Mini-Mental State Examination ≧24 will be included as our participation. The participants will be randomized assigned to treatment group (TG, robot assisted treatment, n=30) and control group (CG, conventional treatment, n=30). In the treatment group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system, the patient will also receive additional conventional treatment. In the control group, the patient will receive 100 minutes conventional treatment. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box \& block test、Brunnstrom recovery Stage, and motor activity log (MAL). The investigators will follow up the patient at the 3rd and 6th month after complete trial.
- Conditions
- Stroke
- Being tested
- RMTC finger-hand robot (Mirror Hand), Conventional OT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMTC finger-hand robot (Mirror Hand)Device
The robotic hand will apply on the patient's affected hand and the sensor glove will apply on the patient's un-affected hand, the patient can manipulate their affected hand by their un-affected hand and do the task oriented bimanual training.
Conventional OTOther
The focus of occupational therapy is to help individuals achieve health, well-being, and participation in life through engagement in activities (American Occupational Therapy Association [AOTA], 2014). For stroke rehabilitation, occupational therapy includes retraining in self-care skills, addressing ongoing deficits such as weakness, sensory loss, and cognitive impairments that limit engagement in activities of daily living, and training in community reintegration and modifying tasks or environments.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Experimental group received Robot Assisted Training (RMTC finger-hand robot (Mirror Hand)) and traditional occupation therapy (Conventional OT) for 1 hour and forty minutes. Receives: Device: RMTC finger-hand robot (Mirror Hand); Other: Conventional OT |
| Control Group | Active comparator | Control group received traditional occupation therapy (Conventional OT) for 1 hour and forty minutes. Receives: Other: Conventional OT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fugl-Meyer Assessment (FMA-Upper limb)
Fugl-Meyer assessment is an stroke specific index for estimating the performance of motor function, Total scores of FMA-Upper limb ranged from 0-66.
Measured: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Secondary outcomes (5)
Change of Modified Ashworth Scale (MAS)
The MAS is an index for estimating the muscle spasticity, minimal is MAS=0 and maximal is MAS=4.
Measured: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Action Research Arm Test (ARAT)
The ARAT is a measurement for evaluating the alteration of upper limb's motor function. Total scores of ARAT ranged from 0-57.
Measured: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Brunnstrom Recovery Stage (BRS)
The BRS is a measurement tool for estimating the motor recovery consist of 6 sequential stages.
Measured: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Box & Block Test (BBT)
The BBT is a measurement for test the unilateral gross manual dexterity. The number of blocks transferred from one compartment of a box to another in 1-minute is counted.
Measured: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Motor Activity Log (MAL)
The MAL is obtained by an interview for stroke patients to assess the use of their affected limb in the daily life, scaled from 0-5.
Measured: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start21 Dec 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841695
- Sponsor's protocol ID
- 201800703A3C601
- Status last verified
- Apr 2022
- First submitted
- 20 Dec 2018
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
PubMed 6932734Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
PubMed 3160243CARROLL D. A QUANTITATIVE TEST OF UPPER EXTREMITY FUNCTION. J Chronic Dis. 1965 May;18:479-91. doi: 10.1016/0021-9681(65)90030-5. No abstract available.
PubMed 14293031Crow JL, Lincoln NB, Nouri FM, De Weerdt W. The effectiveness of EMG biofeedback in the treatment of arm function after stroke. Int Disabil Stud. 1989 Oct-Dec;11(4):155-60. doi: 10.3109/03790798909166667.
PubMed 2701823Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
PubMed 7333761
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of the Rehabotics Medical Technology Corporation (RMTC) Finger-hand Robot on Upper-limb Rehabilitation of Stroke Patients
- ClinicalTrials.gov ID
- NCT03841695
- Acronym / sponsor ID
- 201800703A3C601
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Feb 2019 (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.
In the present study, the RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The participants will be randomized assigned to treatment group (TG, robot assisted treatment) and control group (CG, conventional treatment). In the experimental group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box \& block test、Brunnstrom recovery Stage, and motor activity log (MAL).
Detailed description
Clinical reports indicated the functional recovery of the distal part of upper limb in stroke patient needs time period longer than other body parts, and there is a limitation in the efficiency of conventional treatment on the distal part of upper limb. Robot assisted rehabilitation is a novel application in treatment. Rehabilitation robot is able to assist patients move the affected side through external power to achieve a repeated exercising and further evoke the motor function. In the present study, the wearable RMTC finger-hand robot and combined with the mechanism of neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The patient (post stroke>1 month) age from 20-90 years old with Modified Ashworth Scale ≦2, Brunnstrom Recovery Stage of Arm ≧ 2, Mini-Mental State Examination ≧24 will be included as our participation. The participants will be randomized assigned to treatment group (TG, robot assisted treatment, n=30) and control group (CG, conventional treatment, n=30). In the treatment group, task oriented bi-manual training will be applied using the unaffected hand to guide the affected hand by RMTC robot system, the patient will also receive additional conventional treatment. In the control group, the patient will receive 100 minutes conventional treatment. The investigators will estimate the motor function of distal part of upper-limb before and after treatments. The results will be compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test (ARAT), Box \& block test、Brunnstrom recovery Stage, and motor activity log (MAL). The investigators will follow up the patient at the 3rd and 6th month after complete trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: RMTC finger-hand robot (Mirror Hand), Other: Conventional OTExperimental group received Robot Assisted Training (RMTC finger-hand robot (Mirror Hand)) and traditional occupation therapy (Conventional OT) for 1 hour and forty minutes. |
| Control Group | Active comparator | Other: Conventional OTControl group received traditional occupation therapy (Conventional OT) for 1 hour and forty minutes. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Modified Ashworth Scale, MAS≦2
- Brunnstrom Recovery Stage of Arm≧2
- Mini-Mental State Examination; MMSE≧24
- aged from 20-90 years
- first stroke ≧1 month
Key exclusion criteria (4 listed)
- poor cognitive ability (such as moderate to severe dementia, etc.) or mental illness (such as convulsions)
- wrist musculoskeletal system disease (such as fractures, tendon rupture, etc.) can not withstand external forces
- skin disorders (such as pressure sores, trauma, cellulitis, etc.)
- cerebellar stroke
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 |
|---|---|---|
| RMTC finger-hand robot (Mirror Hand)The robotic hand will apply on the patient's affected hand and the sensor glove will apply on the patient's un-affected hand, the patient can manipulate their affected hand by their un-affected hand and do the task oriented bimanual training. | Device | Treatment Group |
| Conventional OTThe focus of occupational therapy is to help individuals achieve health, well-being, and participation in life through engagement in activities (American Occupational Therapy Association [AOTA], 2014). For stroke rehabilitation, occupational therapy includes retraining in self-care skills, addressing ongoing deficits such as weakness, sensory loss, and cognitive impairments that limit engagement in activities of daily living, and training in community reintegration and modifying tasks or environments. | Other | Control Group, Treatment Group |
Primary outcome
Change of Fugl-Meyer Assessment (FMA-Upper limb)
Time frame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Fugl-Meyer assessment is an stroke specific index for estimating the performance of motor function, Total scores of FMA-Upper limb ranged from 0-66.
5 secondary outcomes
Change of Modified Ashworth Scale (MAS)
Time frame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Action Research Arm Test (ARAT)
Time frame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Brunnstrom Recovery Stage (BRS)
Time frame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Box & Block Test (BBT)
Time frame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
Change of Motor Activity Log (MAL)
Time frame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)
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 27 May 2022.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 6932734Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
- Background: PubMed 3160243Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
- Background: PubMed 14293031CARROLL D. A QUANTITATIVE TEST OF UPPER EXTREMITY FUNCTION. J Chronic Dis. 1965 May;18:479-91. doi: 10.1016/0021-9681(65)90030-5. No abstract available.
- Background: PubMed 2701823Crow JL, Lincoln NB, Nouri FM, De Weerdt W. The effectiveness of EMG biofeedback in the treatment of arm function after stroke. Int Disabil Stud. 1989 Oct-Dec;11(4):155-60. doi: 10.3109/03790798909166667.
- Background: PubMed 7333761Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
- 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.
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 RMTC finger-hand robot (Mirror Hand) and Conventional OT in people with Stroke, run by Chang Gung Memorial 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 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 27 May 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 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?
Change of Fugl-Meyer Assessment (FMA-Upper limb) (time frame: Measurement will be performed at pre-treatment (0 months), treatment completion (post-treatment, an average of 4 weeks), 1 and 3 months (follow-up)). 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 NCT03841695, which also lists 6 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 27 May 2022.