StrokeNCT03104881

Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

A study testing 3D exoskeleton type robot and 2D end-effector type robot in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: 3D exoskeleton type robot and 2D end-effector type robot
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSouth Korea
Study dates: Apr 2015to Mar 2017
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 18 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
8 ≤ Fugl-Meyer Assessment score ≤ 30
Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
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

National Rehabilitation Center
Seoul, Seoul, 142884

Other trials in South Korea

About this study

Official title: Comparisons of Two Types of Rehabilitation Robot for Upper Extremities: 3 Dimension Exoskeleton Type Upper Extremity Robot vs. 2 Dimension End-effector Type Robot): Randomized Controlled Trial

Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)

Conditions: Stroke
Being tested: 3D exoskeleton type robot, 2D end-effector type robot
Keywords: stroke
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3D exoskeleton type robotDevice
3 dimension exoskeleton type upper extremity robot
2D end-effector type robotDevice
2 dimension end-effector type upper extremity robot

Study groups in NCT03104881
Study group	Role	What they receive
3D exoskeleton type robot	Experimental	3 dimension exoskeleton type upper extremity robot Receives: Device: 3D exoskeleton type robot
2D end-effector type robot	Experimental	2 dimension end-effector type upper extremity robot Receives: Device: 2D end-effector type robot

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Fugl-Meyer Assessment
Measured: Fugl-Meyer Assessment change from baseline at 4 weeks
Wolf motor function test
Measured: Fugl-Meyer Assessment change from baseline at 4 weeks

Secondary outcomes (16)

Wolf motor function test
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Motor status score
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
medical research council scale of upper extremity
Measured: baseline
Modified Ashworth scale of upeer extremity
Measured: baseline
Pain of upper extremity
Pain complaints from participants
Measured: from baseline to 4 weeks after baseline
Stroke impact scale
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Smoothness
Kinematics from Inmotion2 during point-to-point
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Reach Error
Kinematics from Inmotion2 during point-to-point
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Path Error
Kinematics from Inmotion2 during point-to-point
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Mean velocity
Kinematics from Inmotion2 during point-to-point
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Maximum velocity
Kinematics from Inmotion2 during point-to-point
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Cricle size
Kinematics from Inmotion2 during circle drawing
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Cricle independence
Kinematics from Inmotion2 during circle drawing
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Intrinsic motivation inventory
Measured: 4 weeks after baseline
stroke rehabilitation motivation scale
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Beck depression index
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Mar 2017

First posted7 Apr 2017
Study startApr 2015
Primary completionMar 2017
Study completionMar 2017

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.
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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03104881
Sponsor's protocol ID: NRC-2015-01-005
Status last verified: Apr 2017
First submitted: 23 Oct 2016
Last updated: 12 Apr 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparisons of Two Types of Rehabilitation Robot for Upper Extremities: 3 Dimension Exoskeleton Type Upper Extremity Robot vs. 2 Dimension End-effector Type Robot): Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03104881
Acronym / sponsor ID: NRC-2015-01-005
Conditions: Stroke
Keywords: stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: National Rehabilitation Center, Seoul, KoreaOther government
Study start: Apr 2015
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 7 Apr 2017 (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.

Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
3D exoskeleton type robot	Experimental	Device: 3D exoskeleton type robot3 dimension exoskeleton type upper extremity robot
2D end-effector type robot	Experimental	Device: 2D end-effector type robot2 dimension end-effector type upper extremity robot

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Hemiplegic patients secondary to first cerebrovascular accidents
Onset ≥ 3 months
8 ≤ Fugl-Meyer Assessment score ≤ 30
Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
Cognitively intact enough to understand and follow the instructions from the investigator

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
3D exoskeleton type robot3 dimension exoskeleton type upper extremity robot	Device	3D exoskeleton type robot
2D end-effector type robot2 dimension end-effector type upper extremity robot	Device	2D end-effector type robot

Primary outcome

Change of Fugl-Meyer Assessment
Time frame: Fugl-Meyer Assessment change from baseline at 4 weeks
Wolf motor function test
Time frame: Fugl-Meyer Assessment change from baseline at 4 weeks

16 secondary outcomes

Wolf motor function test
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Motor status score
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
medical research council scale of upper extremity
Time frame: baseline
Modified Ashworth scale of upeer extremity
Time frame: baseline
Pain of upper extremity
Time frame: from baseline to 4 weeks after baseline
Stroke impact scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Smoothness
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Reach Error
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Path Error
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Mean velocity
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Maximum velocity
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Cricle size
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Cricle independence
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Intrinsic motivation inventory
Time frame: 4 weeks after baseline
stroke rehabilitation motivation scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Beck depression index
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

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 12 Apr 2017.
Site of the present studyLink provided by the sponsor.

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.

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 3D exoskeleton type robot and 2D end-effector type robot 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 5 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: finished, as of the sponsor's last update on 12 Apr 2017. 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?

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 (time frame: Fugl-Meyer Assessment change from baseline at 4 weeks). 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 NCT03104881.

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 12 Apr 2017.