StrokeNCT03465267
Comparisons of Two Types of Armeo Robot for Upper Extremities
A study testing Armeo power and Armeo spring in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Armeo power and Armeo spring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 31 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic patients secondary to first cerebrovascular accidents
- Onset ≥ 3 months
- 26 ≤ Fugl-Meyer Assessment score ≤ 50
- 3 ≤ Shoulder or elbow MRC scale ≤ 4
- Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+
- Cognitively intact enough to understand and follow the instructions from the investigator
Who cannot join
- History of surgery of affected upper limb
- Fracture of affected upper limb
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Rehabilitation Center
Seoul, 142884
Joon-Ho Shin, MS
Joon-Ho Shin, MS
About this study
Official title: Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial
Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function
Read the detailed description
The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist.
Thus the results from this study might suggest usefulness of motorized robot.
- Conditions
- Stroke
- Being tested
- Armeo power, Armeo spring
- Keywords
- stroke, upper extremity rehabilitation robot, stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo powerDevice
Intervention with Armeo power rehabilitation robot for upper extremity (made by Hocoma), which provide assistive force.
The intervention was done 4 weeks, 5 times/week, 30 minutes/day.
Armeo springDevice
Intervention with Armeo spring rehabilitation robot for upper extremity (made by Hocoma), which is operated only by participants, without any assistive force from robot.
The intervention was done 4 weeks, 5 times/week, 30 minutes/day.
| Study group | Role | What they receive |
|---|---|---|
| Armeo power | Experimental | Armeo power robot for upper extremity Receives: Device: Armeo power |
| Armeo spring | Experimental | Armeo spring robot for upper extremity Receives: Device: Armeo spring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Wolf motor function test
Change of Wolf motor function test
Measured: change from baseline at 4 weeks
Secondary outcomes (11)
Fugl-Meyer Assessment
Fugl-Meyer Assessment
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale
Stroke impact scale (Health-related quality of life measurements in stroke patients)
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Motor activity log
Motor activity log
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Mean velocity of upper extremity during reaching task
Curvature of the magnetic sensor trajectory (Kinematics of upper extremity)during reaching task
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Curvature of upper extremity during reaching task
Curvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jerk of upper extremity during reaching task
Jerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
% maximal voluntary contraction of upper extremity muscles during reaching task
surface EMG of upper extremity during reaching task
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Behavioral activation system/behavioral inhibition system scale
Behavioral activation system subscale, behavioral inhibition system subscale
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression index
Beck depression index
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
Intrinsic motivation inventory
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
Stroke rehabilitation motivation scale
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, MS, Principal investigator, National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465267
- Sponsor's protocol ID
- NRC-2017-01-007
- Status last verified
- Mar 2018
- First submitted
- 1 Mar 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JH, Park G, Kim HY, Lee JY, Ham Y, Hwang D, Kwon S, Shin JH. A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study. J Neuroeng Rehabil. 2020 Oct 19;17(1):137. doi: 10.1186/s12984-020-00763-6.
PubMed 33076952
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03465267
- Acronym / sponsor ID
- NRC-2017-01-007
- Conditions
- Stroke
- Keywords
- stroke, upper extremity rehabilitation robot, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 14 Mar 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.
Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function
Detailed description
The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist.
Thus the results from this study might suggest usefulness of motorized robot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armeo power | Experimental | Device: Armeo powerArmeo power robot for upper extremity |
| Armeo spring | Experimental | Device: Armeo springArmeo spring robot for upper extremity |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hemiplegic patients secondary to first cerebrovascular accidents
- Onset ≥ 3 months
- 26 ≤ Fugl-Meyer Assessment score ≤ 50
- 3 ≤ Shoulder or elbow MRC scale ≤ 4
- Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+
Key exclusion criteria (2 listed)
- History of surgery of affected upper limb
- Fracture of affected upper limb
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 |
|---|---|---|
| Armeo powerIntervention with Armeo power rehabilitation robot for upper extremity (made by Hocoma), which provide assistive force. The intervention was done 4 weeks, 5 times/week, 30 minutes/day. | Device | Armeo power |
| Armeo springIntervention with Armeo spring rehabilitation robot for upper extremity (made by Hocoma), which is operated only by participants, without any assistive force from robot. The intervention was done 4 weeks, 5 times/week, 30 minutes/day. | Device | Armeo spring |
Primary outcome
Change of Wolf motor function test
Time frame: change from baseline at 4 weeks
Change of Wolf motor function test
11 secondary outcomes
Fugl-Meyer Assessment
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Motor activity log
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Mean velocity of upper extremity during reaching task
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Curvature of upper extremity during reaching task
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jerk of upper extremity during reaching task
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
% maximal voluntary contraction of upper extremity muscles during reaching task
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Behavioral activation system/behavioral inhibition system scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression index
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Derived from this study: PubMed 33076952Park JH, Park G, Kim HY, Lee JY, Ham Y, Hwang D, Kwon S, Shin JH. A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study. J Neuroeng Rehabil. 2020 Oct 19;17(1):137. doi: 10.1186/s12984-020-00763-6.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Joon-Ho Shin, MS principal investigator
National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armeo power and Armeo spring in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Mar 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon-Ho Shin, MS (82-2-901-1884, asfreelyas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Wolf motor function test (time frame: change from baseline at 4 weeks). 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 NCT03465267, 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 14 Mar 2018.