StrokePhase 4NCT02228863
Upper Extremity Rehabilitation Using Robot and Botulinum Toxin
A Phase 4 study testing Early Inmotion and Botox, Botox, then Inmotion and Inmotion, then Botox in people with Stroke and Spasticity, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spasticity
- What is being tested?
- Early Inmotion and Botox, Botox, then Inmotion and Inmotion, then Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Feb 2017
- Phase
- Phase 4
- 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
- Shoulder or Elbow flexor spasticity above or 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
- Recent history of botulinum toxin injection within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Rehabilitation Center
Seoul, Seoul, 142884
Joon-Ho Shin, MS, 82-901-1884, asfreelyas@gmail.com
Joon-Ho Shin, MS
About this study
Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.
- Conditions
- Stroke, Spasticity
- Being tested
- Early Inmotion and Botox, Botox, then Inmotion, Inmotion, then Botox, Late Inmotion and Botox
- Keywords
- Stroke, Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Inmotion and BotoxOther
Concomitant use of Inmotion and Botox from the baseline
Botox, then InmotionOther
At baseline Botox injection and 4 weeks after Inmotion
Inmotion, then BotoxOther
Inmotion from the baseline, then Botox injection at 4 weeks after baseline
Late Inmotion and BotoxOther
No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection
| Study group | Role | What they receive |
|---|---|---|
| Early Inmotion and Botox | Experimental | Concomitant use of Inmotion and botulinum toxin from the baseline Receives: Other: Early Inmotion and Botox |
| Botox, then Inmotion | Active comparator | Inmotion training 4 weeks after botulinum toxin injection Receives: Other: Botox, then Inmotion |
| Inmotion, then Botox | Active comparator | From the baseline Inmotion, then Botox injection at 4 weeks after baseline Receives: Other: Inmotion, then Botox |
| Late Inmotion and Botox | Active comparator | No intervention, then Inmotion and Botox injection at 4 weeks from the baseline Receives: Other: Late Inmotion and Botox |
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 8 weeks
Secondary outcomes (15)
Kinematic data
Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Spasticity of elbow and shoulder joint
Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Medical research council scale of elbow and shoulder joint strength
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Painless range of motion of elbow and shoulder joint
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
numeric rating scale of pain of elbow and shoulder joint
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Associated reaction rating scale
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
surface electromyography data from bilateral upper extremities
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Behavioral activation system/behavioral inhition system scale
In terms of motivation
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Controlled Oral Word Association Test
Controlled Oral Word Association Test during baseline, 5 days of Inmotion, 20 days of Inmotion.
The test was done at rest and with Inmotion trial
Measured: baseline, 5ays of Inmotion, 20 days of Inmotion
Fugl-Meyer Assessment
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Stroke impact scale
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Beck's depression index
Measured: baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
Satisfaction about the intervention
Measured: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Adverse event
Measured: From baseline to 12 weeks from the baseline
Digit span test
Digit span test(forward, backward) during baseline, 5 days of Inmotion, 20 days of Inmotion.
The test was done at rest and with Inmotion trial
Measured: baseline, 5days after Inmotion, 20 days after Inmotion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2017 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 348 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
- NCT02228863
- Sponsor's protocol ID
- NRC-2014-01-005
- Status last verified
- Aug 2014
- First submitted
- 23 Aug 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shin JH, Park G, Kim H, Cho DY, Kwon S. Combined effects and timing of robotic training and botulinum toxin on upper limb spasticity and motor function: a single-blinded randomized controlled pilot study. J Neuroeng Rehabil. 2025 Mar 6;22(1):50. doi: 10.1186/s12984-025-01584-1.
PubMed 40050906
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Rehabilitation Using Robot and Botulinum Toxin
- ClinicalTrials.gov ID
- NCT02228863
- Acronym / sponsor ID
- NRC-2014-01-005
- Conditions
- Stroke, Spasticity
- Keywords
- Stroke, Spasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- Mar 2014
- Primary completion
- Feb 2017 (estimated)
- First posted
- 29 Aug 2014 (estimated)
- 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.
Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early Inmotion and Botox | Experimental | Other: Early Inmotion and BotoxConcomitant use of Inmotion and botulinum toxin from the baseline |
| Botox, then Inmotion | Active comparator | Other: Botox, then InmotionInmotion training 4 weeks after botulinum toxin injection |
| Inmotion, then Botox | Active comparator | Other: Inmotion, then BotoxFrom the baseline Inmotion, then Botox injection at 4 weeks after baseline |
| Late Inmotion and Botox | Active comparator | Other: Late Inmotion and BotoxNo intervention, then Inmotion and Botox injection at 4 weeks from the baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemiplegic patients secondary to first cerebrovascular accidents
- Shoulder or Elbow flexor spasticity above or modified ashworth scale 1+
- Cognitively intact enough to understand and follow the instructions from the investigator
Key exclusion criteria (3 listed)
- History of surgery of affected upper limb
- Fracture of affected upper limb
- Recent history of botulinum toxin injection within 6 months
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 |
|---|---|---|
| Early Inmotion and BotoxConcomitant use of Inmotion and Botox from the baseline | Other | Early Inmotion and Botox |
| Botox, then InmotionAt baseline Botox injection and 4 weeks after Inmotion | Other | Botox, then Inmotion |
| Inmotion, then BotoxInmotion from the baseline, then Botox injection at 4 weeks after baseline | Other | Inmotion, then Botox |
| Late Inmotion and BotoxNo intervention until 4 weeks from the baseline. Then Inmotion and Botox injection | Other | Late Inmotion and Botox |
Primary outcome
Change of Fugl-Meyer Assessment
Time frame: Fugl-Meyer Assessment change from baseline at 8 weeks
15 secondary outcomes
Kinematic data
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Spasticity of elbow and shoulder joint
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Medical research council scale of elbow and shoulder joint strength
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Painless range of motion of elbow and shoulder joint
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
numeric rating scale of pain of elbow and shoulder joint
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Associated reaction rating scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
surface electromyography data from bilateral upper extremities
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Behavioral activation system/behavioral inhition system scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Controlled Oral Word Association Test
Time frame: baseline, 5ays of Inmotion, 20 days of Inmotion
Fugl-Meyer Assessment
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Stroke impact scale
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Beck's depression index
Time frame: baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
Satisfaction about the intervention
Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Adverse event
Time frame: From baseline to 12 weeks from the baseline
Digit span test
Time frame: baseline, 5days after Inmotion, 20 days after Inmotion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Derived from this study: PubMed 40050906Shin JH, Park G, Kim H, Cho DY, Kwon S. Combined effects and timing of robotic training and botulinum toxin on upper limb spasticity and motor function: a single-blinded randomized controlled pilot study. J Neuroeng Rehabil. 2025 Mar 6;22(1):50. doi: 10.1186/s12984-025-01584-1.
- Site of the present studyLink provided by the sponsor.
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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.
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 Phase 4 study testing Early Inmotion and Botox, Botox, then Inmotion and Inmotion, then Botox in people with Stroke and Spasticity, 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 3 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: status not confirmed, as of the sponsor's last update on 29 Aug 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fugl-Meyer Assessment (time frame: Fugl-Meyer Assessment change from baseline at 8 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 NCT02228863, 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 29 Aug 2014.