Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

Study Overview
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Brief Summary
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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.

Conditions
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Stroke, Spasticity

Intervention / Treatment
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* Other: Early Inmotion and Botox
* Other: Botox, then Inmotion
* Other: Inmotion, then Botox
* Other: Late Inmotion and Botox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Inmotion and Botox<br>Concomitant use of Inmotion and botulinum toxin from the baseline | Other: Early Inmotion and Botox<br>* Concomitant use of Inmotion and Botox from the baseline<br>|
| Active Comparator: Botox, then Inmotion<br>Inmotion training 4 weeks after botulinum toxin injection | Other: Botox, then Inmotion<br>* At baseline Botox injection and 4 weeks after Inmotion<br>|
| Active Comparator: Inmotion, then Botox<br>From the baseline Inmotion, then Botox injection at 4 weeks after baseline | Other: Inmotion, then Botox<br>* Inmotion from the baseline, then Botox injection at 4 weeks after baseline<br>|
| Active Comparator: Late Inmotion and Botox<br>No intervention, then Inmotion and Botox injection at 4 weeks from the baseline | Other: Late Inmotion and Botox<br>* No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fugl-Meyer Assessment |  | Fugl-Meyer Assessment change from baseline at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Spasticity