NMES for Achilles Tendon Rupture
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|ClinicalTrials.gov Identifier: NCT04727047|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2021
Last Update Posted : March 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendon Rupture||Device: neuromuscular electrical stimulation||Not Applicable|
Achilles Tendon Ruptures (ATR) are common and permanently affect the function of the lower leg. Regardless of treatment approach the majority of patients develop long term functional deficits, which include decreased plantar flexion strength, lower heel-rise height, and altered gait patterns. It is believed that tendon lengthening and calf muscle atrophy, which develop during the first few weeks of recovery, are major factors contributing to these functional deficits. The initial development of atrophy is likely caused by reduced loading and muscle activity of the affected leg. However, long-term atrophy may be related to tendon elongation. On the other hand, tendon elongation initially rises during the first few weeks of unloading and slowly reduces, but not completely, when loading is resumed. However, atrophied calf muscles may not provide sufficient loading for optimal tendon recovery. Therefore, there seems to be vicious spiral between tendon elongation and muscle atrophy.
The objective of this study is to develop a neuromuscular electrical stimulation (NMES) rehabilitation protocol for Achilles tendon ruptures. Our preliminary data has shown that force applied to the tendon can be modulated using electrical intensity and pad placement. Therefore, NMES can produce significant contraction in the calf muscles and induce controllable, low-magnitude, cyclic loading to the tendon; which cannot be achieved with voluntary muscle contractions. This approach can potentially overcome limitations of the current rehabilitation protocols.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Neuromuscular Electrical Stimulation for Achilles Tendon Rupture Rehabilitation|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Neuromuscular Electrical Stimulation
Neuromuscular electrical stimulation will be applied to the calf muscles. The level of stimulation will be increased weekly from 10 to 30 mA during the first 6 weeks after surgery.
In addition, patients will follow standard therapy for Achilles tendon repair.
Device: neuromuscular electrical stimulation
All subjects will receive standard rehabilitation for Achilles tendon repair. In addition, neuromuscular electrical stimulation will be applied to the calf muscles of the injured leg. The stimulation volume, the electrode placement and the intensity of the stimulation will be selected based on the mechanical strength of healing Achilles tendon. The intervention will be applied for 6 weeks after repair.
No Intervention: Control
Patients will follow standard therapy for Achilles tendon repair.
- Ability to perform a single heel rise [ Time Frame: Week 12 ]The ability of patients to perform a single heel rise using the injured will be tested.
- Tendon length [ Time Frame: Week 6 and12 ]Length from the tendon insertion to the myotendinous junction
- Tendon cross-sectional area [ Time Frame: Week 6, 12 ]Area of the tendon measured via ultrasound imaging at the rupture location
- Gastrocnemius muscle cross-sectional area [ Time Frame: Week 1, 6, 12 ]Area of the tendon measured via ultrasound imaging at the rupture location
- Soleus muscle cross-sectional area [ Time Frame: Week 1, 6, 12 ]Area of the tendon measured via ultrasound imaging at the rupture location
- Foot and Ankle Outcome Score (FAOS) [ Time Frame: Week 6, 12 ]Score that assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and foot/ankle related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
- Achilles Total Rupture Score [ Time Frame: Week 6, 12 ]It consists of ten items evaluating aspects of symptoms and function. Each item has scores ranging between 0 and 10 on a Likert scale. The instrument therefore has a maximum score of 100, which corresponds to no symptoms and full function.
- Tampa Scale for Kinesiophobia (TSK) [ Time Frame: Week 6, 12 ]Questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727047
|Contact: Daniel Cortesemail@example.com|
|Contact: Andrea Horne||(717) firstname.lastname@example.org|