Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

August 27, 2014 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change of Fugl-Meyer Assessment
Time Frame: Fugl-Meyer Assessment change from baseline at 8 weeks
Fugl-Meyer Assessment change from baseline at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
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
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
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
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Painless range of motion of elbow and shoulder joint
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
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
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Associated reaction rating scale
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
surface electromyography data from bilateral upper extremities
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
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
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
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
baseline, 5ays of Inmotion, 20 days of Inmotion
Fugl-Meyer Assessment
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Stroke impact scale
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Beck's depression index
Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
Satisfaction about the intervention
Time Frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Adverse event
Time Frame: From baseline to 12 weeks from the baseline
From baseline to 12 weeks from the baseline
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
baseline, 5days after Inmotion, 20 days after Inmotion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Rehabilitation Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRC-2014-01-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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