Healthy VolunteersNCT03979235
Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation
An observational study of Healthy Volunteers and Motor Deficits, run by National Research Center for Rehabilitation Technical Aids at 1 site in China.
Trial summary
Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Motor Deficits, Dysphagia
- What is being tested?
- Motor function assessment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruiting with advertising
Who may be able to join
- no history of psychological/psychotic problems, no history of important diseases.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Research Center for Rehabilitation Technical Aids
Beijing, 100176
PX Wei, Dr., 86-10-58122921, pengxuwei@gmail.com
About this study
Official title: Developing Clinic-oriented Quantitative Effectiveness Evaluation and Individualized Therapeutic Programs of Rehabilitation
Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation
Read the detailed description
Using robotics, sensors, sEMG or other methods to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation
- Conditions
- Healthy Volunteers, Motor Deficits, Dysphagia
- Being tested
- Motor function assessment
- Medical subject headings
- Neurologic Manifestations, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor function assessmentDiagnostic test
perform motor function assessment by using scales, sEMG, and inertia sensors
| Study group | Role | What they receive |
|---|---|---|
| Heahlthy people | perform motor function assessment by using scales, sEMG, and inertia sensors Receives: Diagnostic Test: Motor function assessment | |
| People with motor deficits | perform motor function assessment by using scales, sEMG, and inertia sensors Receives: Diagnostic Test: Motor function assessment | |
| Patients with dysphagia | perform motor function assessment by using scales, sEMG, and inertia sensors Receives: Diagnostic Test: Motor function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function assessment
Fugl-Meyer Assessment
Measured: Change from Baseline scores at 1 month
Secondary outcomes (2)
surface EMG
high-density surface EMG
Measured: Change from Baseline status at 1 month
Kinematics test
Using inertia sensors to assess kinematics during movement
Measured: Change from Baseline status at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start5 Jun 2019
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Rehabilitation Technical Aids
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pengxu Wei, National Research Center for Rehabilitation Technical Aids
- Investigators
- PX Wei, PhD, Principal investigator, National Research Center for Rehabilitation Technical Aids
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979235
- Sponsor's protocol ID
- 20180104
- Status last verified
- May 2025
- First submitted
- 5 Jun 2019
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Clinic-oriented Quantitative Effectiveness Evaluation and Individualized Therapeutic Programs of Rehabilitation
- ClinicalTrials.gov ID
- NCT03979235
- Acronym / sponsor ID
- 20180104
- Conditions
- Healthy Volunteers, Motor Deficits, Dysphagia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Research Center for Rehabilitation Technical AidsUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation
Detailed description
Using robotics, sensors, sEMG or other methods to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heahlthy people | – | Diagnostic Test: Motor function assessmentperform motor function assessment by using scales, sEMG, and inertia sensors |
| People with motor deficits | – | Diagnostic Test: Motor function assessmentperform motor function assessment by using scales, sEMG, and inertia sensors |
| Patients with dysphagia | – | Diagnostic Test: Motor function assessmentperform motor function assessment by using scales, sEMG, and inertia sensors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruiting with advertising
Key inclusion criteria (1 listed)
- no history of psychological/psychotic problems, no history of important diseases.
Key exclusion criteria (5 listed)
- history of psychological/psychotic problems
- patients with motor function impairment such as post stroke hemiplegia.
- cognitively or physically unable to cooperate with the examiner to finish the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor function assessmentperform motor function assessment by using scales, sEMG, and inertia sensors | Diagnostic test | Heahlthy people, Patients with dysphagia, People with motor deficits |
Primary outcome
Motor function assessment
Time frame: Change from Baseline scores at 1 month
Fugl-Meyer Assessment
2 secondary outcomes
surface EMG
Time frame: Change from Baseline status at 1 month
Kinematics test
Time frame: Change from Baseline status at 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PX Wei, PhD principal investigator
National Research Center for Rehabilitation Technical Aids
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Motor Deficits, run by National Research Center for Rehabilitation Technical Aids at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LT Wang, PhD (86-10-58122882, suhonglun@nrcrta.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function assessment (time frame: Change from Baseline scores at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.