Skip to content

FAM study

Validation of the PTC vision 4100 device for diagnosing and monitoring neuromuscular conditions and disorders in adults

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TCC-10000959
Enrollment
Unknown
Registered
2010-05-30
Start date
2010-02-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diagnosed knee problems (OA).

Interventions

Group A:Normal subjects baseline FAM assessments without i
Group B:Patiens with knee problems, FAM, biomarkers
Group C:Male and female athletes, change of FAM, muscle st
:Male and female athletes, change of FAM, muscle st

Sponsors

Sichuan Chinese Medical University, The Sports Medicine Hospital, Chengdu Sport University, Sichuan Provincial
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for normative data1. Male/Female, Chinese, aged 20 to 70 years; 2. Apparently healthy and ambulatory with no history of chronical diseases; 3. Understands the procedures of the study as demonstrated by granting Informed Consent. Exclusion Criteria for normative data1. The subject is mentally or legally incapacitated, or otherwise unable to give informed consent.2. The subject is 70 years of age.3. The subject has received any of the following medications (dosages provided as appropriate) in the last 6 months:a. Fluoride (>1 mg/day)b. Estrogen (including topical creams but excluding oral contraceptives)c. SERMS (selective estrogen receptor modulators)d. Progestins (excluding oral contraceptives)e. GnRH Agonistsf. Bisphosphonatesg. Anabolic Steroidh. Calcitonini. Thyroid hormone (must be at stable dose for 12 months).j. Glucocorticoid (either oral or inhaled)k. Calcium (>1500 mg/day)l. Vitamin D (>800 IU/day)4. The subject has experienced any atraumatic fracture.5. The subject has rheumatoid arthritis.6. The subject has osteoarthritis which significantly limits activity.7. The subject has chronic liver, kidney or endocrine disease (including but not limited to insulin-dependent diabetes, Cushing’s disease, Addison’s disease).8. The subject has cancer currently or within last 5 years, with the exception of superficial basal or squamous cell carcinoma of the skin which has been completely resected. (Individuals who have had cancer but survived 5 or more years are eligible.)9. The subject has severe ischemic heart disease, cardiac failure or pulmonary failure.10. The subject has a history of any illness or trauma that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.11. The subject is or has been pregnant within the last 6 months. The subject is or has been breastfeeding within the last 4 months. 12. The subject has anatomy unsuitable for electric assessment. 13. The subject has been immobilized for >1 month within the last year.Inclusion Criteria for efficacy study1. Male/Female, Chinese, aged 20 to 70 years2. Patients with knee problems and objective findings diagnosed by conventional methods.3. Understands the procedures of the study as demonstrated by granting Informed Consent.Inclusion Criteria for recovery after training1. Male/Female, Chinese, aged 20 to 30 years2. Apparently healthy and ambulatory with no history of chronical diseases and as compactive althlets.3. Understands the procedures of the study as demonstrated by granting Informed Consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for normative data 1. The subject is mentally or legally incapacitated, or otherwise unable to give informed consent; 2. The subject is 70 years of age; 3. The subject has received any of the following medications (dosages provided as appropriate) in the last 6 months: a. Fluoride (>1 mg/day); b. Estrogen (including topical creams but excluding oral contraceptives); c. SERMS (selective estrogen receptor modulators); d. Progestins (excluding oral contraceptives); e. GnRH Agonists; f. Bisphosphonates; g. Anabolic Steroid; h. Calcitonin; i. Thyroid hormone (must be at stable dose for 12 months); j. Glucocorticoid (either oral or inhaled); k. Calcium (>1500 mg/day); l. Vitamin D (>800 IU/day); 4. The subject has experienced any atraumatic fracture; 5. The subject has rheumatoid arthritis; 6. The subject has osteoarthritis which significantly limits activity; 7. The subject has chronic liver, kidney or endocrine disease (including but not limited to insulin-dependent diabetes, Cushing's disease, Addison's disease); 8. The subject has cancer currently or within last 5 years, with the exception of superficial basal or squamous cell carcinoma of the skin which has been completely resected. (Individuals who have had cancer but survived 5 or more years are eligible.); 9. The subject has severe ischemic heart disease, cardiac failure or pulmonary failure; 10. The subject has a history of any illness or trauma that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject; 11. The subject is or has been pregnant within the last 6 months. The subject is or has been breastfeeding within the last 4 months; 12. The subject has anatomy unsuitable for electric assessment; 13. The subject has been immobilized for >1 month within the last year; Exclusion Criteria for efficacy study 1.The subject is mentally or legally incapacitated, or otherwise unable to give informed consent; 2. The subject is 70 years of age; 4. The subject has rheumatoid arthritis; 5. The subject has chronic liver, kidney or endocrine disease (including but not limited to insulin-dependent diabetes, Cushing's disease, Addison's disease); 6. The subject has severe ischemic heart disease, cardiac failure or pulmonary failure; 7. The subject has chronic imbalance of eletrolytes of blood; 8. The subject has cancer currently or within last 5 years, with the exception of superficial basal or squamous cell carcinoma of the skin which has been completely resected. (Individuals who have had cancer but survived 5 or more years are eligible.); 9. The subject has a history of any illness or trauma that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject; 10. The subject is or has been pregnant within the last 6 months. The subject is or has been breastfeeding within the last 4 months; 11. The subject has anatomy unsuitable for electric assessment; 12. The subject has been immobilized for >1 month within the last year; Exclusion Criteria for recovery after training: 1. The subject is mentally or legally incapacitated, or otherwise unable to give informed consent; 2. The subject is 30 years of age; 1. The subject has received any of the following medications (dosages provided as appropriate) in the last 6 months: a. Fluoride (>1 mg/day); b. Estrogen (including topical creams but excludin

Design outcomes

Primary

MeasureTime frame
FAM (bio-electric interferential current;

Secondary

MeasureTime frame
MVC/EM;

Countries

China

Contacts

Public ContactSulin Cheng
sulin.cheng@jyu.fi+358 14 2602091

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026