NCT04129853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

October 11, 2019

Last Update Submit

May 26, 2020

Conditions

Lower Limb Amputation Above Knee (Injury)

Keywords

Wearable roboticsUnilateral Lower Limb Amputation

Outcome Measures

Primary Outcomes (23)

  • Physical performance determinant

    duration of the different tests (sec) measured with a chronometer.

    1 year

  • Physical performance determinant

    number of stands during the sit to stand test (number)

    1 year

  • Physical performance determinant

    normal walking speed (m/sec)

    1 year

  • Biomechanical outcome measure

    joint angels (degrees) of flexion and extension of the knee and ankle joint.

    1 year

  • Biomechanical outcome measure

    pressure plots of both the amputated and sound foot (N/m²)

    1 year

  • Biomechanical outcome measure

    cadence during the hallway walking test (steps/mine)

    1 year

  • Biomechanical outcome measure

    step width (cm)

    1 year

  • Biomechanical outcome measure

    step length (cm)

    1 year

  • Biomechanical outcome measure

    swing phases in % of gait cycle

    1 year

  • Biomechanical outcome measure

    stance phases in % of gait cycle

    1 year

  • Electrohysiological outcome measure

    heart rate (bpm)

    1 year

  • Physiological outcome measure

    oxygen uptake (ml/min)

    1 year

  • Physiological outcome measure

    carbon dioxide production (ml/min)

    1 year

  • Physiological outcome measure

    ventilation (L/min)

    1 year

  • Electrohysiological outcome measure

    electrocardiogram

    1 year

  • Electrohysiological outcome measure

    skin temperature (degees celcius)

    1 year

  • Electrohysiological outcome measure

    muscle activity during different movements (% of the MVC)

    1 year

  • Psychological outcome measure

    rating of perceived exertion (arbitrary valu between 0 and 10)

    1 year

  • Psychological outcome measure

    the visual analogue scale (arbitrary value between 0 (worse) and 10 (best))

    1 year

  • Psychological outcome measure

    the EuroQol-5D

    1 year

  • Psychological outcome measure

    the mini-mental state examination (arbitrary value beween 0 and 30)

    1 year

  • Psychological outcome measure

    the prosthetic evaluation questionnaire

    1 year

  • Psychological outcome measure

    the system usability scale

    1 year

Study Arms (2)

Crossover

EXPERIMENTAL

Performing a sit to stand with the Cyberlegs Xleg and comparing with their current prosthesis.

Device: Cyberlegs Xleg

Case study

EXPERIMENTAL

Comparing the cyberlegs xleg with other devices.

Device: Cyberlegs Xleg

Interventions

Cyberlegs XlegDEVICE

Sit to stand, Stair Climbing, Slope walking, L-test, Hallway walking with the current vs. cyberlegs xleg and cyberlegs vs power knee

Case studyCrossover

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Level of amputation: unilateral transfemoral or transtibial
  • Completed the rehabilitation program
  • Functional Medicare Classification K-level 2-4

You may not qualify if:

  • Comorbidity (hemiplegia or neurological diseases)
  • Stump pain or bad fit of the socket

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Jo Ghillebert, msc

CONTACT

0494902770jo.ghillebert@vub.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 17, 2019

Study Start

January 2, 2020

Primary Completion

August 1, 2020

Study Completion

December 31, 2020

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)