Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss (HumanIT)

August 16, 2023 updated by: Kevin De Pauw, Vrije Universiteit Brussel
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The researchers will investigate the beneficial effect of a passive prosthetic ankle (Lunaris®) on functional physical performance, brain neuroplasticity and movement patterns compared to conventional prosthetic feet and able-bodied individuals.

The clinical trial will comprise four test days for participants with a lower limb amputation and two days for the control group of able-bodied individuals.

The able-bodied individuals will undergo an MRI scan at the University Hospital Brussels (dpt. Radiology and Magnetic Resonance) and perform functional performance tests.

Participants with a lower limb amputation will start the clinical trial upon the start of their rehabilitation. At week 0, when initiating the rehabilitation, participants will undergo a baseline MRI scan at the University Hospital Brussels (dpt. Radiology and Magnetic Resonance). Then, they will be allocated to the intervention arms (Lunaris® or the SACH foot®) and will conduct their rehabilitation to learn to walk with a prosthesis. At the end of the rehabilitation, after 12 weeks, participants will perform baseline functional performance tests, fill out the prosthetic evaluation questionnaire (PEQ) measuring the quality of life. Between weeks 12 and 24 of the clinical trial (i.e. intervention period), participants will perform their daily activities with the allocated prosthesis. During weeks 12 - 24, trying out new prosthetic devices will be allowed within the group of individuals wearing the SACH foot® as this is considered the usual care. At the end of this period (after week 24), the post-test assessment will take place and participants will undergo the same MRI and functional performance tests and fill out the PEQ as during the baseline assessments to evaluate the changes that occurred. The 12-week intervention period is chosen based on a study examining the effect of 12 weeks of balance training in healthy and older adults on neuroplasticity and the accommodation time to walking with a new prosthesis.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Unilateral transtibial (below knee) amputation
  • Healthy subject
  • Medicare Functional Classification Level: K3-4

Exclusion Criteria:

  • Any neurological disease
  • Upper limb or bilateral amputation
  • Osso-integration
  • Metal implants
  • Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New prosthesis
20 participants will be fitted with the Lunaris foot and follow the protocol
Device: Prosthetic device (Lunaris)
Participants with an amputation will conduct experiments with the prosthetic device
Active Comparator: Standard prosthesis
20 participants will be fitted with the SACH foot and follow the protocol
Device: Prosthetic device (Sach foot)
Participants with an amputation will conduct experiments with the prosthetic device
Other: Control group of able-bodied individuals
20 able-bodied individuals will be recruited to enable comparison with both groups of participants with lower limb amputation
Other: No prosthetic device
Able-bodied individuals will conduct experiments to enable comparison with the participants with amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain neuroplasticity
Time Frame: Change over 24 weeks
Brain scan: diffusion-weighted imaging
Change over 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance
Time Frame: Change over 12 weeks
time (seconds) to complete L-test
Change over 12 weeks
Performance
Time Frame: Change over 12 weeks
time (seconds) to complete dual-L test
Change over 12 weeks
Performance
Time Frame: Change over 12 weeks
time (seconds) to complete slope walking test
Change over 12 weeks
Performance
Time Frame: Change over 12 weeks
time (seconds) to complete stair climbing test
Change over 12 weeks
Performance
Time Frame: Change over 12 weeks
Accuracy of the dual-L-test in percent
Change over 12 weeks
Biomechanical
Time Frame: Change over 12 weeks
Continious relative phase thigh [calculated from the hip & knee joint angles and velocities]
Change over 12 weeks
Biomechanical
Time Frame: Change over 12 weeks
Continious relative phase knee-ankle calculated from the knee-ankle joint angles and velocities (Lamb et al, 2014)
Change over 12 weeks
Performance
Time Frame: Change over 12 weeks
Distance covered during the 6-minute walk test
Change over 12 weeks
Psychological
Time Frame: Change over 12 weeks
Score on the prosthetic evaluation questionnaire
Change over 12 weeks
Psychological
Time Frame: Change over 12 weeks
Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks
Change over 12 weeks
Psychological
Time Frame: Change over 12 weeks
Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion)
Change over 12 weeks
Psychological
Time Frame: Change over 12 weeks
Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload )
Change over 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Investigators

  • Principal Investigator: Kevin De Pauw, Vrije Universiteit Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EC-2023-089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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