Overseen ByKyle Leister, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sara Peterson-Snyder
No Placebo Group
Trial Summary
What is the purpose of this trial?The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss. Maintaining a healthy, pain-free residual limb is a primary concern for prosthesis users.
Amputees commonly experience muscle deficits leading to mobility issues, poor prosthetic fit, and chronic pain. Neuromuscular electrical stimulation (NMES) is a potential intervention that activates muscles with low-level electrical stimulation, improving strength, function, and reducing pain. The study seeks to understand NMES's effects on muscle parameters and pain to develop evidence-based interventions for amputees.
Twenty participants with transtibial amputations will undergo an 8-week NMES training program. Ultrasound imaging will assess muscle thickness, cross-sectional area, and composition changes. The study aims to enhance mobility, prosthetic fit, and overall well-being of amputees, addressing challenges and reducing healthcare burdens.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does NMES treatment for amputation differ from other treatments?
NMES (Neuromuscular Electrical Stimulation) is unique because it uses electrical impulses to stimulate muscle contractions, which can help maintain muscle function and prevent atrophy (muscle wasting) in amputees. This approach is different from traditional treatments that focus on surgical techniques and prosthetic fittings, as it directly targets muscle health and function.
12345Eligibility Criteria
This trial is for individuals who have undergone transtibial amputation and are looking to improve muscle mass, function, and reduce pain in their residual limbs. Participants should be willing to undergo an 8-week NMES training program.Inclusion Criteria
My BMI is 35 or less.
I am 18 years old or older.
I have one leg amputated below the knee.
My current pain level is 3 or higher on a pain scale.
I passed a sensitivity test on my amputated limb for electrical stimulation.
My limbs move and function normally.
Exclusion Criteria
I have had a stroke or nerve damage in my leg.
I have severe diabetes or cannot feel my skin.
I have open wounds or ulcers on my amputated limb.
Participant Groups
The study tests the effectiveness of Neuromuscular Electrical Stimulation (NMES) using the Chattanooga Continuum Device on rebuilding muscle mass and reducing pain in people with below-knee amputations.
1Treatment groups
Experimental Treatment
Group I: NMESExperimental Treatment1 Intervention
All participants will undergo an 8-week Neuromuscular Electrical Stimulation (NMES) intervention using a portable NMES device at home. Participants will use the device on their residual limb to stimulate specific muscle groups (vastus medialis oblique, tibialis anterior, and gastrocnemius muscles). Electrode placement, stimulation intensity, and session frequency will be standardized and tailored to each participant to achieve strong but tolerable muscle contractions.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Cranberry Township BuildingPittsburgh, PA
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Who is running the clinical trial?
Sara Peterson-SnyderLead Sponsor
References
Preservation of the functional above knee stump following hip disarticulation by means of an Austin-Moore prosthesis. [2005]Patients can be provided with a functional above-knee amputation stump when the tumor is not resectable. In order to do this and still remove the entire upper end of the femur a small Austin-Moore prosthesis with drill holes is inserted and enclosed in long anterior and posterior flaps. Muscle attachments are sutured into the distal stem to obtain the balance between abduction and extension of a functional stump.
Recent advances in lower extremity amputations and prosthetics for the combat injured patient. [2022]Blast-related extremity trauma represents a serious challenge because of the extent of bone and soft tissue damage. Fragmentation and blast injuries account for 56% of all injuries produced within the Iraqi and Afghan theaters where, as of July 2009, 723 combatants have sustained lower extremity limb loss. If limb salvage is not practical, or fails, then amputation should be considered. Amputation can be a reliable means toward pain relief and improvement of function. Optimizing functional outcome is paramount when deciding on definitive amputation level. Preservation of joint function improves limb biomechanics in many cases. Increased limb length also allows for the benefits associated with articular and distal limb proprioception. Amputees with improved lower extremity function also usually exhibit less energy consumption. Function and length are generally directly correlated, whereas energy consumption and length are inversely related. This article discusses the surgical principles of lower extremity amputation and postoperative management of amputees, and the various prosthetic options available.
[Minor amputations: a maxi task : Part 2: From transmetatarsal amputation to hindfoot amputation]. [2022]The definitive aim of a minor amputation is limited resection with retention of feet and legs resulting in a completely loadable extremity, in contrast to the lower leg stump. A shift in the amputation level in the sense of a shortening is inevitably accompanied by a reduction in the stand area, an increase in axial pressure and a disruption of muscle equilibrium in the extent of movement of the rest of the foot. This knowledge forms the central issue for further treatment of minor amputations in addition to the subtle treatment of the skin of the sole for coverage of a tension-free tip of the stump. Advantageous are longitudinal partial amputations of the forefoot and midfoot.
Does closed incision negative wound pressure therapy in non-traumatic major lower-extremity amputations improve survival rates? [2022]Closed incision negative pressure wound therapy (CINPWT) has been shown to be clinically effective compared with the traditional gauze dressing, reducing surgical site infections and wound complications. We evaluated the effect of CINPWT compared with gauze dressing on the need for revision surgery and survival after non-traumatic major lower amputation. We included 309 patients undergoing 403 major lower amputations in a retrospective study from January 1, 2010 to November 23, 2017. A total of 139 patients received CINPWT, and 170 patients received stump bandage. There was no statistically significant difference between the two groups regarding the need for revision surgery (P = .45). Fourteen stump bandage patients and 15 CINPWT patients died in hospital (P = .57). One year after amputation, 55 CINPWT patients and 66 stump bandage patients had died (P = .82). Survival probabilities adjusted for age and gender 2 years after amputation were .52 (.43-.61) and .49 (.42-.58), respectively, and 3 years after amputation were .36 (.25-.50) and .39 (.32-.47), respectively. We also found no significant difference in the need for revision surgery in survival probabilities up till 3 years after amputation between patients treated with CINPWT and patients treated with gauze bandage postoperatively.
Below-knee amputation: a modern approach. [2022]Immediate and long-term results of 113 below-knee amputations in 103 patients are presented to justify a comprehensive program of management that includes an objective method for determining amputation level with xenon 133 clearance, precise surgical technic, immediate postoperative prosthesis, and an aggressive program of rehabilitaion. Prediction of healing of the last 30 below-knee amputations was 100% successful, showing the value of 133Xe clearance for determination of amputation level. Zero per cent thirty-day mortality and 100% prosthetic rehabilitation of patients on below-knee prostheses justifies the use of immediate postoperative prosthesis. Long-term follow-up of our patients demonstrates that the five year survival rate of diabetic patients is poor (39%) compared with the nondiabetic amputee (75%) who approached the survival of the normal, age-adjusted male population (85%). The fact that 75% of patients were alive after five years and were still independently ambulatory on their prostheses is final testimony to the value of the program.