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Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

Primary Purpose

Stroke, Spasticity

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Early Inmotion and Botox
Botox, then Inmotion
Inmotion, then Botox
Late Inmotion and Botox
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Spasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Early Inmotion and Botox

Botox, then Inmotion

Inmotion, then Botox

Late Inmotion and Botox

Arm Description

Concomitant use of Inmotion and botulinum toxin from the baseline

Inmotion training 4 weeks after botulinum toxin injection

From the baseline Inmotion, then Botox injection at 4 weeks after baseline

No intervention, then Inmotion and Botox injection at 4 weeks from the baseline

Outcomes

Primary Outcome Measures

Change of Fugl-Meyer Assessment

Secondary Outcome Measures

Kinematic data
Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion
Spasticity of elbow and shoulder joint
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
Painless range of motion of elbow and shoulder joint
numeric rating scale of pain of elbow and shoulder joint
Associated reaction rating scale
surface electromyography data from bilateral upper extremities
Behavioral activation system/behavioral inhition system scale
In terms of motivation
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
Fugl-Meyer Assessment
Stroke impact scale
Beck's depression index
Satisfaction about the intervention
Adverse event
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

Full Information

First Posted
August 23, 2014
Last Updated
August 27, 2014
Sponsor
National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02228863
Brief Title
Upper Extremity Rehabilitation Using Robot and Botulinum Toxin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity
Keywords
Stroke, Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Inmotion and Botox
Arm Type
Experimental
Arm Description
Concomitant use of Inmotion and botulinum toxin from the baseline
Arm Title
Botox, then Inmotion
Arm Type
Active Comparator
Arm Description
Inmotion training 4 weeks after botulinum toxin injection
Arm Title
Inmotion, then Botox
Arm Type
Active Comparator
Arm Description
From the baseline Inmotion, then Botox injection at 4 weeks after baseline
Arm Title
Late Inmotion and Botox
Arm Type
Active Comparator
Arm Description
No intervention, then Inmotion and Botox injection at 4 weeks from the baseline
Intervention Type
Other
Intervention Name(s)
Early Inmotion and Botox
Intervention Description
Concomitant use of Inmotion and Botox from the baseline
Intervention Type
Other
Intervention Name(s)
Botox, then Inmotion
Intervention Description
At baseline Botox injection and 4 weeks after Inmotion
Intervention Type
Other
Intervention Name(s)
Inmotion, then Botox
Intervention Description
Inmotion from the baseline, then Botox injection at 4 weeks after baseline
Intervention Type
Other
Intervention Name(s)
Late Inmotion and Botox
Intervention Description
No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection
Primary Outcome Measure Information:
Title
Change of Fugl-Meyer Assessment
Time Frame
Fugl-Meyer Assessment change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Kinematic data
Description
Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Spasticity of elbow and shoulder joint
Description
Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Medical research council scale of elbow and shoulder joint strength
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Painless range of motion of elbow and shoulder joint
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
numeric rating scale of pain of elbow and shoulder joint
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Associated reaction rating scale
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
surface electromyography data from bilateral upper extremities
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Behavioral activation system/behavioral inhition system scale
Description
In terms of motivation
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Controlled Oral Word Association Test
Description
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
Time Frame
baseline, 5ays of Inmotion, 20 days of Inmotion
Title
Fugl-Meyer Assessment
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Title
Stroke impact scale
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Beck's depression index
Time Frame
baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
Title
Satisfaction about the intervention
Time Frame
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Adverse event
Time Frame
From baseline to 12 weeks from the baseline
Title
Digit span test
Description
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
Time Frame
baseline, 5days after Inmotion, 20 days after Inmotion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon-Ho Shin, MS
Phone
82-2-901-1884
Email
asfreelyas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
Phone
82-901-1884
Email
asfreelyas@gmail.com
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS

12. IPD Sharing Statement

Links:
URL
http://nrc.go.kr
Description
Site of the present study

Learn more about this trial

Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

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