The Efficacy of the Cyberlegs Xleg During Daily Activities in People With a Unilateral Lower Limb Amputation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Vrije Universiteit Brussel
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Psychological outcome measure
Study Overview
Brief Summary
The aim of the project is to evaluate the efficacy of the Cyberlegs X-leg in people with a unilateral transfemoral (above the knee joint) and transtibial (under the knee joint) amputation. De Cyberlegs X-leg is in continuation of the development of the Cyberlegs gamma-prototype (B.U.N. 143201732970; FAMHP reference number: 80M0725). The Cyberlegs X-leg is a motorized prosthesis which replaces the amputated part of the leg. Our hypothesis is that people with a lower limb amputation perform daily activities (e.g. walking, stair climbing, sit to stand, et cetera) easier, more comfortable and more efficient with the X-leg compared to their current prosthesis. Assessments will be based on a holistic approach in which biomechanical, physiological and psychological parameters are determined.
Detailed Description
Study design A crossover study and a case study design.
Subjects Number of subjects 14 participants will be recruited for this study.
Inclusion criteria Age:18 - 80 year Gender: men and women Level of amputation: unilateral transfemoral or transtibial Completed the rehabilitation program Functional Medicare Classification K-level 2-4
Exclusion criteria Comorbidity (hemiplegia or neurological diseases) Stump pain or bad fit of the socket
Procedures Recruitment process Experiments will take place at the research group Human Physiology and Sports Physiotherapy of campus Etterbeek from the Vrije Universiteit Brussel (Belgium). Participants will be recruited via clinical rehabilitation centers, such as V!GO (Wetteren or Pellenberg, Belgium), Jessa hospital (Hasselt, Belgium) or via advertisement and flyers. All participants will be providing written and oral information about the experimental protocol, potential risks and benefits before giving informed consent to participate in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Level of amputation: unilateral transfemoral or transtibial
- •Completed the rehabilitation program
- •Functional Medicare Classification K-level 2-4
Exclusion Criteria
- •Comorbidity (hemiplegia or neurological diseases)
- •Stump pain or bad fit of the socket
Arms & Interventions
Crossover
Performing a sit to stand with the Cyberlegs Xleg and comparing with their current prosthesis.
Intervention: Cyberlegs Xleg (Device)
Case study
Comparing the cyberlegs xleg with other devices.
Intervention: Cyberlegs Xleg (Device)
Outcomes
Primary Outcomes
Psychological outcome measure
Time Frame: 1 year
rating of perceived exertion (arbitrary valu between 0 and 10)
Physical performance determinant
Time Frame: 1 year
duration of the different tests (sec) measured with a chronometer.
Biomechanical outcome measure
Time Frame: 1 year
joint angels (degrees) of flexion and extension of the knee and ankle joint.
Electrohysiological outcome measure
Time Frame: 1 year
heart rate (bpm)
Physiological outcome measure
Time Frame: 1 year
oxygen uptake (ml/min)
Secondary Outcomes
No secondary outcomes reported
Investigators
Jo Ghillebert
PhD candidate
Vrije Universiteit Brussel