Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04727047
Status:
RECRUITING
Last Update Posted:
2023-05-12
First Post:
2020-10-15
Brief Title:
NMES for Achilles Tendon Rupture
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Neuromuscular Electrical Stimulation for Achilles Tendon Rupture Rehabilitation
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The majority of patients suffering an Achilles tendon rupture develop long term functional deficits in the affected leg The goal of the proposed study is to evaluate a new rehabilitation protocol using Neuromuscular Electrical Stimulation NMES for reducing muscle atrophy and improving tendon properties If proven beneficial the proposed protocol can be easily adopted and incorporated as part of routine care for Achilles tendon rupture
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None