NCT03376919

Brief Summary

The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho prosthesis to improve the mobility and the quality of life in transfemoral amputees . This research focusses on the physical and mental effort needed in locomotion-related tasks and human robot interaction in transfemoral amputees using a novel active prosthesis. This is an international project and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings. In this first clinical study, 16 patients with unilateral trans-femoral amputation, 8 at the Vrije Universiteit Brussel Department Human Physiology Research group (VUB-MFYS) and 8 at the Don Gnocchi Foundation, center of Florence.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

November 27, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

Same day

First QC Date

November 27, 2017

Last Update Submit

December 22, 2017

Conditions

Lower Limb Amputation Above Knee (Injury)

Keywords

wearable roboticsUnilateral Lower Limb Amputationgait efficiency

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure

    oxygen uptake (ml.kg)/carbondioxide production (ml.kg)

    through 6 minutes

Secondary Outcomes (11)

  • 6-Minute Walk Test (6MWT)

    through 6 minutes

  • Timed Up & Go test

    through 14 seconds

  • Sit to stand test

    through 5 minutes

  • Slope walking

    through 5 minutes

  • Borg scale-ratings of perceived exertion

    minute 6

  • +6 more secondary outcomes

Study Arms (1)

CLs++

EXPERIMENTAL

CLs ++ gait training

Device: CLs++ gait training

Interventions

CLs++ gait trainingDEVICE

CLs++ gait training

CLs++

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral trans-femoral amputees both sex age: 30 - 80 yrs Functional K-level 1-4

You may not qualify if:

  • Severe comorbidity (hemiplegia, degenerative nervous system diseases, severe hip or knee arthrosis,chronic heart failure, chronic obstructive pulmonary, hip or knee replacement, severe sensory deficit
  • Pain of the stump/socket poor fitting
  • Inability to walk (safely) on a treadmill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 19, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

January 1, 2021

Last Updated

December 27, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share