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出境医 / 临床实验 / Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation

Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation

Study Description
Brief Summary:
Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and Individualized programs of rehabilitation

Condition or disease Intervention/treatment
Healthy Volunteers Motor Deficits Dysphagia Diagnostic Test: Motor function assessment

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Clinic-oriented Quantitative Effectiveness Evaluation and Individualized Therapeutic Programs of Rehabilitation
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Heahlthy people
perform motor function assessment by using scales, sEMG, and inertia sensors
 Diagnostic Test: Motor function assessment
perform motor function assessment by using scales, sEMG, and inertia sensors
People with motor deficits
perform motor function assessment by using scales, sEMG, and inertia sensors
 Diagnostic Test: Motor function assessment
perform motor function assessment by using scales, sEMG, and inertia sensors
Patients with dysphagia
perform motor function assessment by using scales, sEMG, and inertia sensors
 Diagnostic Test: Motor function assessment
perform motor function assessment by using scales, sEMG, and inertia sensors
Outcome Measures
Primary Outcome Measures :
  1. Motor function assessment [ Time Frame: Change from Baseline scores at 1 month ]
    Fugl-Meyer Assessment


Secondary Outcome Measures :
  1. surface EMG [ Time Frame: Change from Baseline status at 1 month ]
    high-density surface EMG

  2. Kinematics test [ Time Frame: Change from Baseline status at 1 month ]
    Using inertia sensors to assess kinematics during movement


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Recruiting with advertising
Criteria

Inclusion Criteria (for healthy people):

  • no history of psychological/psychotic problems, no history of important diseases.

Exclusion Criteria (for healthy people):

  • history of psychological/psychotic problems

Inclusion Criteria (for patients with motor deficits or dysphagia):

  • patients with motor function impairment such as post stroke hemiplegia.

Exclusion Criteria (for patients with motor deficits or dysphagia):

  • cognitively or physically unable to cooperate with the examiner to finish the test
Contacts and Locations

Contacts
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Contact: HL Su, Dr 86-10-58122882 suhonglun@nrcrta.cn
Contact: PX Wei, Dr 86-10-58122921 pengxuwei@gmail.com

Locations
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China
National Research Center for Rehabilitation Technical Aids Recruiting
Beijing, China, 100176
Contact: PX Wei, Dr.    86-10-58122921    pengxuwei@gmail.com   
Sponsors and Collaborators
National Research Center for Rehabilitation Technical Aids
Tracking Information
First Submitted Date June 5, 2019
First Posted Date June 7, 2019
Last Update Posted Date September 10, 2020
Actual Study Start Date June 5, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019) 		Motor function assessment [ Time Frame: Change from Baseline scores at 1 month ]
Fugl-Meyer Assessment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 6, 2019)
  • surface EMG [ Time Frame: Change from Baseline status at 1 month ]
    high-density surface EMG
  • Kinematics test [ Time Frame: Change from Baseline status at 1 month ]
    Using inertia sensors to assess kinematics during movement
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation
Official Title Developing Clinic-oriented Quantitative Effectiveness Evaluation and Individualized Therapeutic Programs of Rehabilitation
Brief Summary Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and Individualized programs of rehabilitation
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Recruiting with advertising
Condition
  • Healthy Volunteers
  • Motor Deficits
  • Dysphagia
Intervention Diagnostic Test: Motor function assessment
perform motor function assessment by using scales, sEMG, and inertia sensors
Study Groups/Cohorts
  • Heahlthy people
    perform motor function assessment by using scales, sEMG, and inertia sensors
    Intervention: Diagnostic Test: Motor function assessment
  • People with motor deficits
    perform motor function assessment by using scales, sEMG, and inertia sensors
    Intervention: Diagnostic Test: Motor function assessment
  • Patients with dysphagia
    perform motor function assessment by using scales, sEMG, and inertia sensors
    Intervention: Diagnostic Test: Motor function assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 6, 2019) 		40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria (for healthy people):

  • no history of psychological/psychotic problems, no history of important diseases.

Exclusion Criteria (for healthy people):

  • history of psychological/psychotic problems

Inclusion Criteria (for patients with motor deficits or dysphagia):

  • patients with motor function impairment such as post stroke hemiplegia.

Exclusion Criteria (for patients with motor deficits or dysphagia):

  • cognitively or physically unable to cooperate with the examiner to finish the test
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: HL Su, Dr 86-10-58122882 suhonglun@nrcrta.cn
Contact: PX Wei, Dr 86-10-58122921 pengxuwei@gmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03979235
Other Study ID Numbers 20180104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Pengxu Wei, National Research Center for Rehabilitation Technical Aids
Study Sponsor National Research Center for Rehabilitation Technical Aids
Collaborators Not Provided
Investigators Not Provided
PRS Account National Research Center for Rehabilitation Technical Aids
Verification Date September 2020

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