Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

Stroke Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228863
• Other study ID #: NRC-2014-01-005
• Status: Recruiting
• Phase: Phase 4
• First received: August 23, 2014
• Last updated: August 27, 2014
• Start date: March 2014

Study information

• Verified date: August 2014
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin, MS
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity
• Stroke

Intervention

Other:
• Early Inmotion and Botox
Concomitant use of Inmotion and Botox from the baseline
• Botox, then Inmotion
At baseline Botox injection and 4 weeks after Inmotion
• Inmotion, then Botox
Inmotion from the baseline, then Botox injection at 4 weeks after baseline
• Late Inmotion and Botox
No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Fugl-Meyer Assessment		Fugl-Meyer Assessment change from baseline at 8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Medical research council scale of elbow and shoulder joint strength		baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	Painless range of motion of elbow and shoulder joint		baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	numeric rating scale of pain of elbow and shoulder joint		baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	Associated reaction rating scale		baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	surface electromyography data from bilateral upper extremities		baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	Behavioral activation system/behavioral inhition system scale	In terms of motivation	baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	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	No
Secondary	Fugl-Meyer Assessment		Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline	No
Secondary	Stroke impact scale		baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	Beck's depression index		baseline, 4 weeks, 8 weeks, and 12 weeks from baseline	No
Secondary	Satisfaction about the intervention		baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline	No
Secondary	Adverse event		From baseline to 12 weeks from the baseline	Yes
Secondary	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.	No

External Links

•   Site of the present study