- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05396404
Empirical Mode Decomposition and Decision Tree in Sarcopenia
Using Empirical Mode Decomposition and Decision Tree to Extract the Balance and Gait Features and Classification in Sarcopenia
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- aged from 40 - 90
- DXA test performed
- blood sample tests were performed
Exclusion Criteria:
- stroke history
- amputation
- cancer related disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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observation
all subject data were retrieved from databank which is stored in the e-medical chart system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
center of pressure (COP)
Time Frame: baseline: subject was enrolled
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Use computerized dynography to measure the postural sway displacement, velocity (etc., mm, mm/sec)
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baseline: subject was enrolled
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walking speed
Time Frame: baseline: subject was enrolled
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6m, patients can walk with foot orthosis and assistive devices
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baseline: subject was enrolled
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grip force
Time Frame: baseline: subject was enrolled
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Use a grip force meter (kg) to test both hands for test 3 times
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baseline: subject was enrolled
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step time
Time Frame: baseline: subject was enrolled
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Use computerized dynography to measure spatial gait parameter: step time (ms)
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baseline: subject was enrolled
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stance time
Time Frame: baseline: subject was enrolled
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Use computerized dynography to measure spatial gait parameter: stance time (ms)
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baseline: subject was enrolled
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swing time
Time Frame: baseline: subject was enrolled
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Use computerized dynography to measure spatial gait parameter: swing time (ms)
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baseline: subject was enrolled
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step / stance length
Time Frame: baseline: subject was enrolled
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Use computerized dynography to measure spatial gait parameter: step / stance distance (mm)
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baseline: subject was enrolled
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muscle thickness
Time Frame: baseline: subject was enrolled
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Use ultrasound to assess muscles morphological parameter: thickness (mm).
Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
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baseline: subject was enrolled
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international Quality of Life Assessment Short Form -36 (SF-36)
Time Frame: baseline: subject was enrolled
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including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions. Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
baseline: subject was enrolled
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amplitude of Muscle activity
Time Frame: baseline: subject was enrolled
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use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters.
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baseline: subject was enrolled
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Fear of fall scale
Time Frame: baseline: subject was enrolled
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A 15-item self-report questionnaire for measuring fear of falling.
Each item is rated on a Likert-type scale from 1 (strongly disagree) to 4 (strongly agree).
The total possible score ranges from 15-60, with higher scores indicating greater fear of falling.
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baseline: subject was enrolled
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Bone density
Time Frame: baseline: subject was enrolled
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A bone density test, DEXA, measures the mineral content of the bones in certain areas of the skeleton.
A DEXA scan is a type of medical imaging test.
It uses very low levels of x-rays to measure how dense participants' bones are.
DEXA stands for "dual-energy X-ray absorptiometry."
The bone density area includes: Hip and Spine
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baseline: subject was enrolled
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Body composition
Time Frame: baseline: subject was enrolled
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Dual energy x-ray absorptiometry (DEXA) measures bone mineral content (BMC), fat-free mass (FFM).
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baseline: subject was enrolled
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
concentration of CRP (C-Reactive Protein)
Time Frame: baseline: subject was enrolled
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The concentration of CRP in the blood test.
CRP is used mainly as a marker of inflammation.
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baseline: subject was enrolled
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concentration of ALB (Serum albumin)
Time Frame: baseline: subject was enrolled
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The concentration of ALB in the blood test.
Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.
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baseline: subject was enrolled
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concentration of Glomerular Filtration Rate (GFR)
Time Frame: baseline: subject was enrolled
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The concentration of GFR in the blood test.
The glomerular filtration rate is the best test to measure the patient's level of kidney function and determine the stage of kidney disease.
It can calculate it from the results of the blood creatinine test.
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baseline: subject was enrolled
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concentration of Hemoglobin (Hb)
Time Frame: baseline: subject was enrolled
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The concentration of Hb in the blood test.
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baseline: subject was enrolled
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concentration of Glucose SPOT
Time Frame: baseline: subject was enrolled
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The concentration of Glucose SPOT in the blood test.
TheSpot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation
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baseline: subject was enrolled
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concentration of Cholesterol
Time Frame: baseline: subject was enrolled
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The concentration of Cholesterol in the blood test.
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baseline: subject was enrolled
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concentration of Triglyceride
Time Frame: baseline: subject was enrolled
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The concentration of Triglyceride in the blood test.
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baseline: subject was enrolled
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concentration of Transferrin
Time Frame: baseline: subject was enrolled
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The concentration of Transferrin in the blood test.
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baseline: subject was enrolled
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Berg balance test (BBS)
Time Frame: baseline: subject was enrolled
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including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores. The item scores are summed, minimum score =0, maximum score = 56 |
baseline: subject was enrolled
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Body Mass Index (BMI)
Time Frame: baseline: subject was enrolled
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(body weight) kg/(height) m*(height)m
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baseline: subject was enrolled
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Mini-mental state examination (MMSE)
Time Frame: baseline: subject was enrolled
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It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. |
baseline: subject was enrolled
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calf muscle circumference
Time Frame: baseline: subject was enrolled
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Use ruler to measure the bilateral calf muscle circumference, It is an anthropometric parameter commonly used in clinical practice.
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baseline: subject was enrolled
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Timed up and go
Time Frame: baseline: subject was enrolled
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To determine fall risk and measure the progress of balance, sit to stand and walking.
Patients wear their regular footwear and can use a walking aid, if needed.
The patient starts in a seated position.
The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.
The time stops when the patient is seated.
To document if the assistive device used.
Stopwatch to record the whole task duration.
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baseline: subject was enrolled
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: TASEN WEI, MD, Changhua Christian Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCH IRB 211235
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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