Clinical trial NCT02228863: Upper Extremity Rehabilitation Using Robot and Botulinum Toxin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Spasticity
Keywords: Stroke
Spasticity
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2014-08-29
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Fugl-Meyer Assessment
timeFrame: Fugl-Meyer Assessment change from baseline at 8 weeks
Secondary outcomes:
measure: Kinematic data
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
measure: Spasticity of elbow and shoulder joint
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Medical research council scale of elbow and shoulder joint strength
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Painless range of motion of elbow and shoulder joint
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: numeric rating scale of pain of elbow and shoulder joint
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Associated reaction rating scale
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: surface electromyography data from bilateral upper extremities
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Behavioral activation system/behavioral inhition system scale
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Controlled Oral Word Association Test
timeFrame: baseline, 5ays of Inmotion, 20 days of Inmotion
measure: Fugl-Meyer Assessment
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
measure: Stroke impact scale
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Beck's depression index
timeFrame: baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
measure: Satisfaction about the intervention
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Adverse event
timeFrame: From baseline to 12 weeks from the baseline
measure: Digit span test
timeFrame: baseline, 5days after Inmotion, 20 days after Inmotion.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin, MS
role: PRINCIPAL_INVESTIGATOR
References: