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

Sponsor
Vrije Universiteit Brussel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05818410
Collaborator
(none)
60
Enrollment
3
Arms
19.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.

Condition or Disease Intervention/Treatment Phase
  • Device: Prosthetic device (Lunaris)
  • Other: No prosthetic device
  • Device: Prosthetic device (Sach foot)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
Anticipated Study Start Date :
May 31, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Brain neuroplasticity [Change over 24 weeks]

    Brain scan: diffusion-weighted imaging

Secondary Outcome Measures

  1. Performance [Change over 12 weeks]

    time (seconds) to complete L-test

  2. Performance [Change over 12 weeks]

    time (seconds) to complete dual-L test

  3. Performance [Change over 12 weeks]

    time (seconds) to complete slope walking test

  4. Performance [Change over 12 weeks]

    time (seconds) to complete stair climbing test

  5. Performance [Change over 12 weeks]

    Accuracy of the dual-L-test in percent

  6. Biomechanical [Change over 12 weeks]

    Continious relative phase thigh [calculated from the hip & knee joint angles and velocities]

  7. Biomechanical [Change over 12 weeks]

    Continious relative phase knee-ankle calculated from the knee-ankle joint angles and velocities (Lamb et al, 2014)

  8. Performance [Change over 12 weeks]

    Distance covered during the 6-minute walk test

  9. Psychological [Change over 12 weeks]

    Score on the prosthetic evaluation questionnaire

  10. Psychological [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

  11. Psychological [Change over 12 weeks]

    Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion)

  12. Psychological [Change over 12 weeks]

    Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload )

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  • Vascular cause of amputation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vrije Universiteit Brussel

Investigators

  • Principal Investigator: Kevin De Pauw, Vrije Universiteit Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kevin De Pauw, Prof. Dr., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT05818410
Other Study ID Numbers:
  • EC-2023-089
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 18, 2023