Spasticity, Stroke
Conditions
Keywords
Stroke, Spasticity
Brief summary
Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.
Interventions
OTHEREarly Inmotion and Botox
Concomitant use of Inmotion and Botox from the baseline
OTHERBotox, then Inmotion
At baseline Botox injection and 4 weeks after Inmotion
OTHERInmotion, then Botox
Inmotion from the baseline, then Botox injection at 4 weeks after baseline
OTHERLate Inmotion and Botox
No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection
Sponsors
National Rehabilitation Center, Seoul, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* History of surgery of affected upper limb * Fracture of affected upper limb * Recent history of botulinum toxin injection within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Fugl-Meyer Assessment | Fugl-Meyer Assessment change from baseline at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spasticity of elbow and shoulder joint | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline | Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint |
| 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 | baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline | In terms of motivation |
| Kinematic data | Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline | Kinematic data from motion analysis (Vicon) Kinematic data from 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 | baseline, 5days after Inmotion, 20 days after Inmotion. | 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 |
| Controlled Oral Word Association Test | baseline, 5ays of Inmotion, 20 days of Inmotion | 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 |
Countries
South Korea
Contacts
Primary ContactJoon-Ho Shin, MS
Outcome results
None listed