Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601088
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Achilles Tendon Rupture - Intervention With Electrical Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Acute Achilles Tendon Rupture - Intervention With Neuromuscular Electrical Stimulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C-NMES-ATR
Brief Summary:
Acute Achilles tendon rupture ATR is an injury that is commonly associated with complications such as blood clotting muscle loss and tendon lengthening all of which affect the long-term outcome and return to sports These complication are related to the treatment of ATR with lower leg immobilization in a boot
The investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation C-NMES during leg immobilization after ATR can 1 reduce blood clots 2 lower the degree of muscle loss 3 decrease tendon lengthening and 4 improve long-term outcome
The investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation C-NMES during leg immobilization after ATR can 1 reduce blood clots 2 lower the degree of muscle loss 3 decrease tendon lengthening and 4 improve long-term outcome
Detailed Description:
The participants will be divided by chance into two separate groups that compare standard treatment control group with C-NMES in addition to standard treatment intervention group
A total of 220 patients with diagnosed ATR will be included The control group will be treated according to the standard regimen with a lower leg immobilization in a stable orthosis during eight weeks The intervention group will during the eight weeks lower limb immobilization receive an additional intervention with C-NMES underneath the orthosis
The total number of blood clots venous thromboembolism incidence up to mobilization is defined as deep venous thrombosis leg blood clots assessed by screening duplex ultrasound or pulmonary embolism lung blood clots Calf muscle loss tendon length and weight-bearing will be studied at two and eight weeks At six weeks and 12 months validated self-reported function ATRS and self-reported health return to sports calf muscle function and tendon length will be recorded for comparison between the two treatment groups Secondary outcomes are coagulation factors healing biomarkers and cardiovascular biomarkers
The results of this study should contribute to an improved treatment regimen after ATR that allows for a safer and quicker return to activity and sports Adjuvant NMES can readily be implemented in daily healthcare to lower complication risks improve healing reduce healthcare costs and improve return to sports
A total of 220 patients with diagnosed ATR will be included The control group will be treated according to the standard regimen with a lower leg immobilization in a stable orthosis during eight weeks The intervention group will during the eight weeks lower limb immobilization receive an additional intervention with C-NMES underneath the orthosis
The total number of blood clots venous thromboembolism incidence up to mobilization is defined as deep venous thrombosis leg blood clots assessed by screening duplex ultrasound or pulmonary embolism lung blood clots Calf muscle loss tendon length and weight-bearing will be studied at two and eight weeks At six weeks and 12 months validated self-reported function ATRS and self-reported health return to sports calf muscle function and tendon length will be recorded for comparison between the two treatment groups Secondary outcomes are coagulation factors healing biomarkers and cardiovascular biomarkers
The results of this study should contribute to an improved treatment regimen after ATR that allows for a safer and quicker return to activity and sports Adjuvant NMES can readily be implemented in daily healthcare to lower complication risks improve healing reduce healthcare costs and improve return to sports
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None