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Amputation clinical trials

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NCT ID: NCT06168396 Recruiting - Amputation Clinical Trials

Somatosensation Device Trial

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.

NCT ID: NCT06167330 Recruiting - Amputation Clinical Trials

TITAN Trial: Reducing Phantom Limb Pain in People With Amputations

TITAN
Start date: December 18, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effectiveness of two rehabilitation programs for individuals who have undergone amputations and are experiencing phantom limb pain. The main question it aims to answer is: - In individuals who have undergone amputations and are experiencing phantom limb pain, what is the effectiveness of a progressive rehabilitation program compared to a treatment program consisting of transcutaneous electrical nerve stimulation and cranial electrical stimulation on reducing pain intensity and pain interference? A total of 208 participants will be randomized into two groups: progressive rehabilitation program and stimulation devices. The progressive rehabilitation program includes pain science education, sensory training, and left/right judgements, imagined movements and mirror therapy. The treatment program for the group receiving the stimulation devices includes transcutaneous electrical nerve stimulation and cranial electrical stimulation. Both interventions will be delivered via eight, up to 1-hour telehealth sessions. Outcome measures will be assessed at baseline and weeks 12, 24 and 52.

NCT ID: NCT06160882 Recruiting - Amputation Clinical Trials

Powered Prosthesis for Use With TF Osseointegration Recipients

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate functional mobility, control, and user satisfaction from persons who have an amputation above the knee and have received osseo-integration (OI) and targeted muscle reinnervation (TMR) surgery, while walking with a powered knee and ankle prosthesis.

NCT ID: NCT06138977 Recruiting - Amputation Clinical Trials

Controlling Locomotion Over Continuously Varying Activities for Agile Powered Prosthetic Legs

Start date: December 6, 2023
Phase: N/A
Study type: Interventional

The overall goal of this project is to model human joint biomechanics over continuously-varying locomotion to enable adaptive control of powered above-knee prostheses. The central hypothesis of this project is that variable joint impedance can be parameterized by a continuous model based on measurable quantities called phase and task variables. This project will use machine learning to identify variable impedance functions from able-bodied data including joint perturbation responses across the phase/task space to bias the solution toward biological values.

NCT ID: NCT06031922 Recruiting - Amputation Clinical Trials

Effectiveness and Cost-effectiveness of Lower Limb Prostheses

Start date: June 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to investigate the effectiveness of NMPKs versus MPKs in persons with an LLA in the standard healthcare system in the Netherlands taking all levels of the ICF model into account. Our main aim is to assess the effect of MPK use compared to NMPK use on walking distance, as this is one of the most used outcome variables in literature and thus enables comparison with previous studies. Our secondary aim is to investigate the effect of NMPKs versus MPKs on all ICF-levels: body structures and function, activities and participation. Participants will be seen four times in a year. During these measurement moments they will: - Perform two physical tests - Fill out a set of questionnaires - Wear an activity tracker for one week

NCT ID: NCT05989113 Recruiting - Amputation Clinical Trials

Psychometric Qualities IPAQ-SF

QUAPSY
Start date: May 3, 2023
Phase:
Study type: Observational

This is an observational, prospective multicentric study designed to develop medical knowledge. The aim of the study is to validate the IPAQ-SF questionnaire in a population of lower limb amputee patients. The questionnaire is administered twice to each patient, once during the consultation and again when they return home. Patients also undergo a 6-minute walk test.

NCT ID: NCT05975970 Recruiting - Amputation Clinical Trials

A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days. These individuals will be randomized to Group A (Control Group using conventional motor imagery exercises) and Group B (who will train with the MyoTrain AR system pre-prosthetically). The investigators will test the following hypothesis: Pre-prosthetic training with the MyoTrain AR system, as compared to the current standard of care with conventional motor imagery exercises, results in improved subsequent control stability with the prosthesis. Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will repeat the functional assessment. Participants will then receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo a battery of validated, clinical assessments.

NCT ID: NCT05955378 Recruiting - Amputation Clinical Trials

Assessing the DSR Ankle

Start date: July 15, 2023
Phase: N/A
Study type: Interventional

This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle. The DSR ankle is a new design to support a person while they walk on both even and uneven ground, as well as with bending the ankle for safe foot clearance while a person takes a step. In particular, in this study we are interested in seeing how this type of new device may benefit people who are rated as a K2-level ambulator.

NCT ID: NCT05925712 Recruiting - Amputation Clinical Trials

Aerofit Post Market Investigation

Start date: June 6, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.

NCT ID: NCT05888428 Recruiting - Amputation Clinical Trials

Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss

Start date: February 2, 2024
Phase: N/A
Study type: Interventional

The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system). The investigators will test three hypotheses: 1. The use of MyoTrain results in skills transference to control of the final prosthesis 2. The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures 3. The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.