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Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Inmotion and Botox | Experimental | Concomitant use of Inmotion and botulinum toxin from the baseline |
|
| Botox, then Inmotion | Active Comparator | Inmotion training 4 weeks after botulinum toxin injection |
|
| Inmotion, then Botox | Active Comparator | From the baseline Inmotion, then Botox injection at 4 weeks after baseline |
|
| Late Inmotion and Botox | Active Comparator | No intervention, then Inmotion and Botox injection at 4 weeks from the baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Inmotion and Botox | Other | Concomitant use of Inmotion and Botox from the baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fugl-Meyer Assessment | Fugl-Meyer Assessment change from baseline at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic data | Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline |
| Spasticity of elbow and shoulder joint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joon-Ho Shin, MS | Contact | 82-2-901-1884 | asfreelyas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Joon-Ho Shin, MS | National Rehabilitation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Rehabilitation Center | Recruiting | Seoul | Seoul | 142884 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40050906 | Derived | 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. |
| Label | URL |
|---|---|
| Site of the present study | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botox, then Inmotion | Other | At baseline Botox injection and 4 weeks after Inmotion |
|
| Inmotion, then Botox | Other | Inmotion from the baseline, then Botox injection at 4 weeks after baseline |
|
| Late Inmotion and Botox | Other | No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection |
|
Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint
| baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| Medical research council scale of elbow and shoulder joint strength | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| Painless range of motion of elbow and shoulder joint | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| numeric rating scale of pain of elbow and shoulder joint | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| Associated reaction rating scale | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| surface electromyography data from bilateral upper extremities | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| Behavioral activation system/behavioral inhition system scale | In terms of motivation | 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 | baseline, 5ays of Inmotion, 20 days of Inmotion |
| Fugl-Meyer Assessment | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline |
| Stroke impact scale | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| Beck's depression index | baseline, 4 weeks, 8 weeks, and 12 weeks from baseline |
| Satisfaction about the intervention | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline |
| Adverse event | 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 | baseline, 5days after Inmotion, 20 days after Inmotion. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |