Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
17 de junio de 2026 actualizado por: University of Illinois at Chicago
Improving Muscle Strength and Function After Lower Limb Amputation
The goal of this clinical trial is to learn if ischemic conditioning and neuromuscular electrical stimulation improves muscle strength and walking behavior in those with limb loss. The main questions this trial aims to answer are:
Does neuromuscular electrical stimulation improve muscle strength and gait behavior in people who have a leg amputation?
Does neuromuscular electrical stimulation boost the effects of ischemic conditioning on muscle strength and gait behavior in people who have a leg amputation?
Researchers will compare the effects of neuromuscular electrical stimulation to ischemic conditioning to see if there are any significant differences between the impacts of each intervention. Also, researchers will use both interventions together to see if the interventions can boost each other's positive impacts on walking and function in people with leg amputation.
Participants will:
- Do ischemic conditioning OR neuromuscular electrical stimulation OR both interventions at home every other day for 2 weeks
- Visit the laboratory before and after completing interventions for the tests
- Visit the laboratory one week after the post intervention visit for follow-up tests
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
24
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nikou Nikoumanesh
- Número de teléfono: 857-919-4211
- Correo electrónico: nniko@uic.edu
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60607
- University of Illinois Chicago
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Older than 18 years old
- History of unilateral transfemoral or transtibial amputation
- Able to ambulate independently without the use of aids (i.e., walking cane)
- Able to walk at least 6 minutes continuously without stopping.
- Has a safe residuum with no open wounds on either the residual or intact limb
- Has a prosthetic limb with materials that are sound and safe to withstand the mobility requirements of the study
Exclusion Criteria:
- Younger than 18 years old
- Inability to give informed consent
- Neurological disorder such as multiple sclerosis that affects gait
- Currently pregnant (or intend to become pregnant while participating in study)
- Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg)
- History of uncontrolled hypertension
- History of heart failure
- Implanted electrical device such as a pacemaker or defibrillator
- Head injury within the previous 6 months
- Seizure disorder
- History of thrombosis
- History of sickle cell trait
- History of genetic disease that impacts gait (e.g. cerebral palsy, muscular dystrophy).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Ischemic Conditioning
|
A blood pressure cuff will be used for ischemic conditioning, which is a non-invasive intervention that involves episodes of muscle ischemia (restriction of blood flow) followed by reperfusion (restoration of blood flow).
|
|
Experimental: Neuromuscular Electrical Stimulation
|
Neuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions.
|
|
Experimental: Neuromuscular Electrical Stimulation + Ischemic Conditioning
|
A blood pressure cuff will be used for ischemic conditioning, which is a non-invasive intervention that involves episodes of muscle ischemia (restriction of blood flow) followed by reperfusion (restoration of blood flow).
Neuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in the self-selected gait speed (m/s) at week 3 and 4
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk at their self-selected gait speed (m/s) for 6 minutes on a split-belt treadmill at the 1st, 9th, and 10th visits.
The change in gait speed from the first visit will be calculated by SPSS v. 31.0
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Change from baseline in the hip's isometric muscle strength (N.m/kg) using a handheld dynamometer at the 3rd and 4th weeks.
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be positioned supine on a treatment table with a neutral position (legs shoulder-width apart) and will hold their arms by their chest.
The handheld dynamometer will be placed at 20 centimeters distal to the greater trochanter.
For participants with shorter residual limbs, the lever arm will be adjusted, and the handheld dynamometer will be placed on the distal side of the residual limb.
Participants will be asked to perform three maximal contractions for 3 to 5 seconds with a 1-minute rest interval for each limb.
The highest score of the three maximal contractions will be used for analysis.
During all strength measurements, verbal encouragement will be given.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in gait kinematics (angle) through gait motion analysis at 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits.
The changes in gait kinematics (angle) at the ankle, knee, hip joints, and trunk will be analyzed using waveform analysis from the first visit.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in gait kinetics (N.m) through gait motion analysis at 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits.
The changes in gait kinetics (N.m) at the ankle, knee, hip joints, and trunk will be analyzed using waveform analysis from the first visit.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes from baseline in daily mobility tasks (%) using the Prosthetic Limb Users Survey of Mobility short form at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
-Prosthetic Limb Users Survey of Mobility short form is a validated, patient-reported outcome measure used to assess the mobility of adults with lower limb amputations.
It takes about 2 minutes to complete and is widely.
Responses are converted into a standardized T-score.
A score of 50 represents the average mobility of a prosthetic limb user.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in average number of daily steps using an activity monitor at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will wear an activity monitor to assess daily steps.
We will compare the average daily steps before and after receiving the assigned interventions.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the mean seated systolic and diastolic blood pressure (mmHg) at 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
|
Changes from baseline in walking economy (mlO₂ /kg.min) at 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk while wearing a silicone face mask at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits.
Changes in walking economy (ml O₂/kg/min) will be analyzed by assessing the amount of oxygen used (ml O₂), normalized for both body weight (kg) and walking duration (min).
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the carotid-femoral pulse wave velocity (m/s) at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to lay supine on a treatment table for 15 minutes so that blood pressure and cardiac function are similar to basal resting condition for repeatability and to minimize noise.
Central blood pressure and arterial stiffness will be measured using the SphygmoCor.
Carotid-femoral pulse wave velocity is a measure of the time for the arterial pulse to circulate from the carotid to the femoral artery and is considered the gold standard for arterial stiffness measure.
We will measure waveforms on the same side as the intact limb.
All measurements will be made in duplicate and averaged, or triplicate if the difference between two measures is greater than 0.5m/s.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in socket comfort score (out f 10) at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
The Prosthetic Socket Fit Comfort Score is a validated, 11-point self-report scale (ranging from 0 to 10) used by individuals with amputations and their prosthetists to measure and track the comfort of an artificial limb.
O represents the most uncomfortable socket fit, and 10 represents the most comfortable socket fit.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in quality of life (%) using Nottingham Health Profile at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Nottingham Health Profile is a patient-reported questionnaire designed to measure subjective, health-related quality of life.
It takes about 5 minutes to complete and requires simple "yes" or "no" answers.
Scores are calculated using a weighted algorithm and range from 0 (no distress) to 100 (maximum distress).
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the Activities-specific Balance Confidence Scale (%) at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
The Activities-specific Balance Confidence Scale: For each of the specified activities, participants will indicate the level of confidence in doing the activity without losing their balance or becoming unsteady by choosing one of the percentage points on the scale from 0% (No Confidence) to 100% (Completely Confident)
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in Oswestry Low Back Pain (%) at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Oswestry Low Back Pain is widely considered the "gold standard" for measuring how lower back or leg pain impacts a patient's daily functional abilities.
This test consists of 10 sections evaluating different aspects of daily living.
For each category, the participant will select the single statement that best describes their situation.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the average sedentary time (s) using an activity monitor at the 3rd and 4th weeks
Periodo de tiempo: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will wear an activity monitor to calculate the sedentary time (s) per day.
We will compare the average sedentary time before and after receiving the assigned interventions.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
30 de agosto de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
4 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
24 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2026_0262
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .