Coronavirus DiseaseNCT05922865
The Effect of Smart Sensor Combined With APP for Individualized Precise Exercise Training in Long Covid-19
A study testing KNEESUP smart knee assistive device + KNEESUP care APP and Healthy consulation in people with Coronavirus Disease and COVID-19, run by Shang-Lin Chiang at 1 site in Taiwan.
Trial summary
The coronavirus (COVID -19) has rapidly turned into a global pandemic. For patients diagnosed with COVID-19, it caused severe damage in the upper respiratory system and systemic complications, including the cardiovascular, mental, nervous, and musculoskeletal system. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease, COVID-19, Long Covid-19
- What is being tested?
- KNEESUP smart knee assistive device + KNEESUP care APP and Healthy consulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jul 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- symptoms last at least one month after recovery
- without physical impairment
- understood verbal or non-verbal communication
- normal cognitive function
- were willing to participate in the study and accept random allocation
Who cannot join
- diagnosed with transient ischemic attack or stroke
- had neuromuscular injury or surgery in the lower limbs in the past six months
- had heart rhythm regulator
- hospitalized during training
- had aggravated symptoms due to infection again
- had participated in other clinical trials or received other alternative treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tri-service General Hospital, National Defence Medical Center, Taipei, Taiwan
The coronavirus (COVID -19) has rapidly turned into a global pandemic. For patients diagnosed with COVID-19, it caused severe damage in the upper respiratory system and systemic complications, including the cardiovascular, mental, nervous, and musculoskeletal system. Previous research has indicated that these subsequent sequelae can reduce quality of life. (A. W. Wong et al., 2020) Studies have indicated that exercise training is beneficial to improve blood pressure, reduce cardiovascular factors, reduce complications, and relieve depression (J. Galloza et al., 2017) However, the current international research on the benefits of exercise rehabilitation and the improvement of quality of life in patients who have been infected with COVID-19 is still lacking. Under the international epidemic, it is pointed out that the importance of telerehabilitation has also been advocated worldwide. Previous systematic review indicated that no matter it is nervous, muscular or cardiac system disease, the efficacy of telerehabilitation is superior to face-to-face rehabilitation. The purpose of this study is to compare the effect between the intervention of KNEESUP smart knee assistive device, and the health education in routine outpatient after diagnosis of Long Covid-19.
Read the detailed description
The purpose of KNEESUP measuring equipment used in this research is to improve the recovery rate and reduce the sequelae after treatment. KNEESUP connects the subjects and researchers through technologies such as IoT and AI. The evaluation of the rehabilitation results can be presented as a data chart, and the treatment effects are also clearly presented.
For the subject, the subject puts on KNEESUP knee pads in a long sitting position, bends the knees about 30 degrees, aligns the position of the knee pad circle with the bone, and uses the strap on the lower side, upper side, and the knee pads. After wearing, press and hold the sensor on the outer side of the knee pad for 3 seconds, and then open the mobile app. After the hardware setting and connection are completed, the evaluation and exercise can begin.
- Conditions
- Coronavirus Disease, COVID-19, Long Covid-19, Telerehabilitation
- Being tested
- KNEESUP smart knee assistive device + KNEESUP care APP, Healthy consulation
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KNEESUP smart knee assistive device + KNEESUP care APPDevice
In KNEESUP smart knee assistive device + KNEESUP care APP group, participants used the KNEESUP intelligent knee assistive device. Participants wore a knee brace with a sensor module on one side of the leg, the sensor could connect with the KNEESUP care APP which were installed in participant's mobile phone. The APP was designed with an individualized exercise program and the knee brace sensor could detect the action moment of the participants during exercise. This equipment could help the participants to achieve professional-level home rehabilitation.
Healthy consulationBehavioural
In Healthy consulation group, participants received routine outpatient health education.
| Study group | Role | What they receive |
|---|---|---|
| KNEESUP smart knee assistive device + KNEESUP care APP | Experimental | The participants with KNEESUP smart knee assistive device and KNEESUP care APP do exercise training at home. Receives: Device: KNEESUP smart knee assistive device + KNEESUP care APP |
| Health consultation | Placebo comparator | The participants with healthy consultation do exercise training at home. Receives: Behavioral: Healthy consulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity (VO2 max in ml/kg/min )
Maximal VO2 during testing, also means aerobic capacity
Measured: baseline, 12 weeks
Anaerobic Threshold (mL/kg/min)
Anaerobic Threshold (AT) refers to the exercise intensity at which lactate begins to accumulate in the blood at a faster rate than it can be removed. It represents a transition point between predominantly aerobic metabolism (using oxygen) and increased anaerobic metabolism (without sufficient oxygen).
Measured: baseline, 12 weeks
Working load in watt
Maximal Working load during testing
Measured: baseline, 12 weeks
Breathing reserve (ml/kg/min)
A measure used during cardiopulmonary exercise testing (CPET) to assess how much of a person's maximum ventilatory capacity is unused at peak exercise. It reflects the difference between the maximum voluntary ventilation (MVV) and the minute ventilation (VE) reached during exercise.
Measured: baseline, 12 weeks
Rest Heart rate in beat/min
Resting heart rate during exercise testing
Measured: baseline, 12 weeks
O2 pulse in ml/beat
It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.
Measured: baseline, 12 weeks
Systolic blood pressure in mm Hg
The resting blood pressure during exercise testing
Measured: baseline, 12 weeks
Diastolic blood pressure in mm Hg
The resting blood pressure during exercise testing
Measured: baseline, 12 weeks
VE/VCO2 slope
The ventilation/ perfusion abnormalities (VE/VCO2) is measured by graded exercise testing.The change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.
Measured: baseline, 12 weeks
Heart rate recovery
The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery.
The change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of < 12 or 22 beats per minute in 1- or 2- min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.
Measured: baseline, 12 weeks
FVC (L/min)
The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.
Measured: baseline, 12 weeks
FEV1 (L/min)
The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV1 was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1 indicates better lung function.
Measured: baseline, 12 weeks
FEV1/FVC (%)
The measured FEV1 is divided by the measured FVC. he change in FEV1/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.
Measured: baseline, 12 weeks
Gait: Step length (m) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Gait: Speed (m/s) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Gait: Cadence (steps per minute) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Gait: Left gait cycle (sec) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Gait: Right gait cycle (sec) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Gait: Turn around time (sec) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Gait: Stand up time (sec) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Gait: Total walking time (sec) through Time Up and Go Test
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Measured: baseline, 12 weeks
Long COVID symptoms
A simple checklist to record Long COVID symptoms. Symptoms that persisted or were newly developed after acute infection were documented as sequelae. Symptoms included fatigue, shortness of breath, cognitive dysfunction (referred to as "brain fog"), chest pain, cough, dizziness, headache, sleep disturbances, palpitations, depression/anxiety, and olfactory dysfunction.
Measured: baseline, 12 weeks
Secondary outcomes (5)
Quality of life (scores)
The Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) with good validity and reliability includes the globally standardized WHOQOL-BREF with 26 items and an additional two locally developed items, making a total of 28 items. It consists of two single-facet items measuring overall quality of life and general health and four domains, including physical (7 items), psychological (6 items), social (4 items), and environmental (9 items) domains. The two additional items are being respected/accepted facet in the social domain and eating/food facet in the environment domain, respectively. The participants rated all items on a scale of 1-5, with higher scores reflecting a greater quality of life. Domain scores were derived by multiplying the mean of the facet scores within each domain by a scaling factor of 4, resulting in potential domain scores ranging from 4 to 20.
Measured: baseline, 12 weeks
Sleeping Quality (scores)
Symptoms of sleeping quality will be assessed using Pittsburgh Sleeping Index. The content is aimed at the sleep conditions of the subjects, including seven items including personal self-evaluation of sleep quality, sleep latency, sleep hours, sleep efficiency, sleep disturbance, drug use and daytime dysfunction. Each item is calculated by the Likert four-point method, 0-3 points, the total score ranges from 0-21 points, and the higher the score, the worse the sleep quality. (MORGAN, DALLOSSO, EBRAHIM, ARIE, \& Fentem, 1988; Tang Zhenqing et al., 2014).
Measured: baseline, 12 weeks
Body composition: Body weight (kg)
The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.
Measured: baseline, 12 weeks
Body composition: Body fat (%)
The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.
Measured: baseline, 12 weeks
Body composition: Lean mass weight (kg)
The InBody device is a bioelectrical impedance analysis (BIA) system designed to assess body composition in a non-invasive, rapid, and reliable manner. It quantifies key components such as skeletal muscle mass, body fat mass, total body water, and visceral fat area.
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start11 Jul 2023
- Primary completion27 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shang-Lin Chiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shang-Lin Chiang, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922865
- Sponsor's protocol ID
- smart knee assistive device
- Status last verified
- Apr 2025
- First submitted
- 26 Jun 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tri-service General Hospital, National Defence Medical Center, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT05922865
- Acronym / sponsor ID
- smart knee assistive device
- Conditions
- Coronavirus Disease, COVID-19, Long Covid-19, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shang-Lin ChiangUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 28 Jun 2023 (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.
The coronavirus (COVID -19) has rapidly turned into a global pandemic. For patients diagnosed with COVID-19, it caused severe damage in the upper respiratory system and systemic complications, including the cardiovascular, mental, nervous, and musculoskeletal system. Previous research has indicated that these subsequent sequelae can reduce quality of life. (A. W. Wong et al., 2020) Studies have indicated that exercise training is beneficial to improve blood pressure, reduce cardiovascular factors, reduce complications, and relieve depression (J. Galloza et al., 2017) However, the current international research on the benefits of exercise rehabilitation and the improvement of quality of life in patients who have been infected with COVID-19 is still lacking. Under the international epidemic, it is pointed out that the importance of telerehabilitation has also been advocated worldwide. Previous systematic review indicated that no matter it is nervous, muscular or cardiac system disease, the efficacy of telerehabilitation is superior to face-to-face rehabilitation. The purpose of this study is to compare the effect between the intervention of KNEESUP smart knee assistive device, and the health education in routine outpatient after diagnosis of Long Covid-19.
Detailed description
The purpose of KNEESUP measuring equipment used in this research is to improve the recovery rate and reduce the sequelae after treatment. KNEESUP connects the subjects and researchers through technologies such as IoT and AI. The evaluation of the rehabilitation results can be presented as a data chart, and the treatment effects are also clearly presented.
For the subject, the subject puts on KNEESUP knee pads in a long sitting position, bends the knees about 30 degrees, aligns the position of the knee pad circle with the bone, and uses the strap on the lower side, upper side, and the knee pads. After wearing, press and hold the sensor on the outer side of the knee pad for 3 seconds, and then open the mobile app. After the hardware setting and connection are completed, the evaluation and exercise can begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KNEESUP smart knee assistive device + KNEESUP care APP | Experimental | Device: KNEESUP smart knee assistive device + KNEESUP care APPThe participants with KNEESUP smart knee assistive device and KNEESUP care APP do exercise training at home. |
| Health consultation | Placebo comparator | Behavioral: Healthy consulationThe participants with healthy consultation do exercise training at home. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- symptoms last at least one month after recovery
- without physical impairment
- understood verbal or non-verbal communication
- normal cognitive function
- were willing to participate in the study and accept random allocation
Key exclusion criteria (6 listed)
- diagnosed with transient ischemic attack or stroke
- had neuromuscular injury or surgery in the lower limbs in the past six months
- had heart rhythm regulator
- hospitalized during training
- had aggravated symptoms due to infection again
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 |
|---|---|---|
| KNEESUP smart knee assistive device + KNEESUP care APPIn KNEESUP smart knee assistive device + KNEESUP care APP group, participants used the KNEESUP intelligent knee assistive device. Participants wore a knee brace with a sensor module on one side of the leg, the sensor could connect with the KNEESUP care APP which were installed in participant's mobile phone. The APP was designed with an individualized exercise program and the knee brace sensor could detect the action moment of the participants during exercise. This equipment could help the participants to achieve professional-level home rehabilitation. | Device | KNEESUP smart knee assistive device + KNEESUP care APP |
| Healthy consulationIn Healthy consulation group, participants received routine outpatient health education. | Behavioural | Health consultation |
Primary outcome
Aerobic capacity (VO2 max in ml/kg/min )
Time frame: baseline, 12 weeks
Maximal VO2 during testing, also means aerobic capacity
Anaerobic Threshold (mL/kg/min)
Time frame: baseline, 12 weeks
Anaerobic Threshold (AT) refers to the exercise intensity at which lactate begins to accumulate in the blood at a faster rate than it can be removed. It represents a transition point between predominantly aerobic metabolism (using oxygen) and increased anaerobic metabolism (without sufficient oxygen).
Working load in watt
Time frame: baseline, 12 weeks
Maximal Working load during testing
Breathing reserve (ml/kg/min)
Time frame: baseline, 12 weeks
A measure used during cardiopulmonary exercise testing (CPET) to assess how much of a person's maximum ventilatory capacity is unused at peak exercise. It reflects the difference between the maximum voluntary ventilation (MVV) and the minute ventilation (VE) reached during exercise.
Rest Heart rate in beat/min
Time frame: baseline, 12 weeks
Resting heart rate during exercise testing
O2 pulse in ml/beat
Time frame: baseline, 12 weeks
It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.
Systolic blood pressure in mm Hg
Time frame: baseline, 12 weeks
The resting blood pressure during exercise testing
Diastolic blood pressure in mm Hg
Time frame: baseline, 12 weeks
The resting blood pressure during exercise testing
VE/VCO2 slope
Time frame: baseline, 12 weeks
The ventilation/ perfusion abnormalities (VE/VCO2) is measured by graded exercise testing.The change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.
Heart rate recovery
Time frame: baseline, 12 weeks
The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery. The change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of < 12 or 22 beats per minute in 1- or 2- min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.
FVC (L/min)
Time frame: baseline, 12 weeks
The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.
FEV1 (L/min)
Time frame: baseline, 12 weeks
The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV1 was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1 indicates better lung function.
FEV1/FVC (%)
Time frame: baseline, 12 weeks
The measured FEV1 is divided by the measured FVC. he change in FEV1/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV1/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.
Gait: Step length (m) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Gait: Speed (m/s) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Gait: Cadence (steps per minute) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Gait: Left gait cycle (sec) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Gait: Right gait cycle (sec) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Gait: Turn around time (sec) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Gait: Stand up time (sec) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Gait: Total walking time (sec) through Time Up and Go Test
Time frame: baseline, 12 weeks
Analysis software was evaluated using METASENS. Begin by having the participants sit back in a standard arm chair and identify a 3 meters line on the floor. Participants walk forward three meters at the usual speed, turn around and return to the chair before sitting down. The METASENS evaluation analysis software calculates the step length (m), speed (m/s), cadence (steps per minute), left/right gait cycle (sec), left/right knee flexion angle (deg), left/right foot contact extension angle (deg), turn around time (sec), stand up time (sec), total walking time (sec).
Long COVID symptoms
Time frame: baseline, 12 weeks
A simple checklist to record Long COVID symptoms. Symptoms that persisted or were newly developed after acute infection were documented as sequelae. Symptoms included fatigue, shortness of breath, cognitive dysfunction (referred to as "brain fog"), chest pain, cough, dizziness, headache, sleep disturbances, palpitations, depression/anxiety, and olfactory dysfunction.
5 secondary outcomes
Quality of life (scores)
Time frame: baseline, 12 weeks
Sleeping Quality (scores)
Time frame: baseline, 12 weeks
Body composition: Body weight (kg)
Time frame: baseline, 12 weeks
Body composition: Body fat (%)
Time frame: baseline, 12 weeks
Body composition: Lean mass weight (kg)
Time frame: baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Long COVID, COVID-19 (SARS-CoV-2 Infection)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KNEESUP smart knee assistive device + KNEESUP care APP and Healthy consulation in people with Coronavirus Disease and COVID-19, run by Shang-Lin Chiang at 1 site in Taiwan.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Apr 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (VO2 max in ml/kg/min ) (time frame: baseline, 12 weeks). The study lists 22 primary outcomes in all. 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 27 Apr 2025.