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Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

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ClinicalTrials.gov Identifier: NCT02228863
Recruitment Status : Unknown
Verified August 2014 by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea.
Recruitment status was:  Recruiting
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

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.

Condition or disease Intervention/treatment Phase
Stroke Spasticity Other: Early Inmotion and Botox Other: Botox, then Inmotion Other: Inmotion, then Botox Other: Late Inmotion and Botox Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Early Inmotion and Botox
Concomitant use of Inmotion and botulinum toxin from the baseline
Other: Early Inmotion and Botox
Concomitant use of Inmotion and Botox from the baseline

Active Comparator: Botox, then Inmotion
Inmotion training 4 weeks after botulinum toxin injection
Other: Botox, then Inmotion
At baseline Botox injection and 4 weeks after Inmotion

Active Comparator: Inmotion, then Botox
From the baseline Inmotion, then Botox injection at 4 weeks after baseline
Other: Inmotion, then Botox
Inmotion from the baseline, then Botox injection at 4 weeks after baseline

Active Comparator: Late Inmotion and Botox
No intervention, then Inmotion and Botox injection at 4 weeks from the baseline
Other: Late Inmotion and Botox
No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection




Primary Outcome Measures :
  1. Change of Fugl-Meyer Assessment [ Time Frame: Fugl-Meyer Assessment change from baseline at 8 weeks ]

Secondary Outcome Measures :
  1. Kinematic data [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline ]
    Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion

  2. Spasticity of elbow and shoulder joint [ Time Frame: 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

  3. 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 ]
  4. Painless range of motion of elbow and shoulder joint [ Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
  5. 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 ]
  6. Associated reaction rating scale [ Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
  7. surface electromyography data from bilateral upper extremities [ Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
  8. Behavioral activation system/behavioral inhition system scale [ Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
    In terms of motivation

  9. Controlled Oral Word Association Test [ Time Frame: 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


  10. Fugl-Meyer Assessment [ Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline ]
  11. Stroke impact scale [ Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
  12. Beck's depression index [ Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks from baseline ]
  13. Satisfaction about the intervention [ Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
  14. Adverse event [ Time Frame: From baseline to 12 weeks from the baseline ]
  15. Digit span test [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228863


Contacts
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Contact: Joon-Ho Shin, MS 82-2-901-1884 asfreelyas@gmail.com

Locations
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Korea, Republic of
National Rehabilitation Center Recruiting
Seoul, Korea, Republic of, 142884
Contact: Joon-Ho Shin, MS    82-901-1884    asfreelyas@gmail.com   
Principal Investigator: Joon-Ho Shin, MS         
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Investigators
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Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center

Additional Information:
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Responsible Party: Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT02228863     History of Changes
Other Study ID Numbers: NRC-2014-01-005
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
Stroke
Spasticity

Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents