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Proof-of-concept study of automatic ankle exercise to prevent deep venous thrombosis of lower limbs in patients with severe neurological coma

Proof-of-concept study of automatic ankle exercise to prevent deep venous thrombosis of lower limbs in patients with severe neurological coma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096736
Enrollment
Unknown
Registered
2025-02-05
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Deep venous thrombosis of lower extremity in patients with severe neurological coma

Interventions

Intervention group 1:Elastic socks (24h wear) + ankle automatic activity meter treatment twice a day, intervention for 2 weeks, interval >=4 hours, 30min each time
Control group:24h Wear stretch socks
Intervention group 2:Intervention group 2: elastic socks (24h wear) + ankle automatic activity meter treatment 4 times a day for 2 weeks, intervention interval >=4 hours,

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1?age >=18 years old, gender unlimited, new to the NICU basically no active limb movement patients; 2? 5<=GCS<=9 score and ultrasound examination excluded patients who had been resuscitation after surgery or who did not need surgery within 2 weeks; 3? Patients who are expected to remain hospitalized in NICU within 2 weeks; 4?the lower limbs are sound, no structural abnormalities caused by amputation or other reasons or other factors affecting joint activity; 5?Patients whose legal representatives voluntarily agree to participate in this study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Those who meet one of the following conditions are not eligible for inclusion:1?Patients with severe disease and unstable hemodynamics; 2? lower extremity limb deformity or joint structural disease affect passive activity; 3?Patients admitted to hospital have been clearly diagnosed with severe coagulation dysfunction or even diagnosed with DVT; 4?Participants in any other clinical trial within 1 month before baseline; 5?The researcher believes that it is inappropriate to participate in this study; 6?Patients who received anticoagulation or antiplate therapy within 1 week before and after enrollment.

Design outcomes

Primary

MeasureTime frame
Lower extremity venous thrombosis rate;

Secondary

MeasureTime frame
Number of thrombotic vein branches formed within 2 weeks;Change rate of D-Dimer within 2 weeks;Creatine kinase change rate over 2 weeks;

Countries

China

Contacts

Public ContactNa Wang

Xuanwu Hospital Capital Medical University

wangna163_com@126.com+86 13811391616

Outcome results

None listed

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