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

NCT05818410 | Recruiting

• 1 other identifier: EC-2023-089
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lower Limb Amputation Below Knee (Injury)

Outcome Measures

Primary Outcomes (1)

• Brain neuroplasticity

  Brain scan: diffusion-weighted imaging

  Change over 24 weeks

Secondary Outcomes (12)

• Performance

  Change over 12 weeks

• Performance

  Change over 12 weeks

• Performance

  Change over 12 weeks

• Performance

  Change over 12 weeks

• Performance

  Change over 12 weeks

Study Arms (3)

New prosthesis

EXPERIMENTAL

20 participants will be fitted with the Lunaris foot and follow the protocol

Device: Prosthetic device (Lunaris)

Standard prosthesis

ACTIVE COMPARATOR

20 participants will be fitted with the SACH foot and follow the protocol

Device: Prosthetic device (Sach foot)

Control group of able-bodied individuals

OTHER

20 able-bodied individuals will be recruited to enable comparison with both groups of participants with lower limb amputation

Other: No prosthetic device

Interventions

Prosthetic device (Lunaris) DEVICE

Participants with an amputation will conduct experiments with the prosthetic device

New prosthesis

No prosthetic device OTHER

Able-bodied individuals will conduct experiments to enable comparison with the participants with amputation

Control group of able-bodied individuals

Prosthetic device (Sach foot) DEVICE

Participants with an amputation will conduct experiments with the prosthetic device

Standard prosthesis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

RECRUITING

Related Publications (23)

• Cox PD, Frengopoulos CA, Hunter SW, Sealy CM, Deathe AB, Payne MWC. Impact of Course Configuration on 6-Minute Walk Test Performance of People with Lower Extremity Amputations. Physiother Can. 2017;69(3):197-203. doi: 10.3138/ptc.2016-24.

  PMID: 30275635 BACKGROUND

• Howard CL, Wallace C, Perry B, Stokic DS. Comparison of mobility and user satisfaction between a microprocessor knee and a standard prosthetic knee: a summary of seven single-subject trials. Int J Rehabil Res. 2018 Mar;41(1):63-73. doi: 10.1097/MRR.0000000000000267.

  PMID: 29293160 BACKGROUND

• Windrich M, Grimmer M, Christ O, Rinderknecht S, Beckerle P. Active lower limb prosthetics: a systematic review of design issues and solutions. Biomed Eng Online. 2016 Dec 19;15(Suppl 3):140. doi: 10.1186/s12938-016-0284-9.

  PMID: 28105948 BACKGROUND

• Russell Esposito E, Aldridge Whitehead JM, Wilken JM. Step-to-step transition work during level and inclined walking using passive and powered ankle-foot prostheses. Prosthet Orthot Int. 2016 Jun;40(3):311-9. doi: 10.1177/0309364614564021. Epub 2015 Jan 27.

  PMID: 25628378 BACKGROUND

• Molina-Rueda F, Navarro-Fernandez C, Cuesta-Gomez A, Alguacil-Diego IM, Molero-Sanchez A, Carratala-Tejada M. Neuroplasticity Modifications Following a Lower-Limb Amputation: A Systematic Review. PM R. 2019 Dec;11(12):1326-1334. doi: 10.1002/pmrj.12167. Epub 2019 Jun 18.

  PMID: 30989836 BACKGROUND

• Boone DA, Coleman KL. Use of the Prosthesis Evaluation Questionnaire (PEQ). JPO: Journal of Prosthetics and Orthotics. 2006;18(6).

  BACKGROUND

• Ozer S, Young J, Champ C, Burke M. A systematic review of the diagnostic test accuracy of brief cognitive tests to detect amnestic mild cognitive impairment. Int J Geriatr Psychiatry. 2016 Nov;31(11):1139-1150. doi: 10.1002/gps.4444. Epub 2016 Feb 18.

  PMID: 26891238 BACKGROUND

• Rogge AK, Roder B, Zech A, Hotting K. Exercise-induced neuroplasticity: Balance training increases cortical thickness in visual and vestibular cortical regions. Neuroimage. 2018 Oct 1;179:471-479. doi: 10.1016/j.neuroimage.2018.06.065. Epub 2018 Jun 26.

  PMID: 29959048 BACKGROUND

• Rogge AK, Roder B, Zech A, Nagel V, Hollander K, Braumann KM, Hotting K. Balance training improves memory and spatial cognition in healthy adults. Sci Rep. 2017 Jul 18;7(1):5661. doi: 10.1038/s41598-017-06071-9.

  PMID: 28720898 BACKGROUND

• Mahon CE, Hendershot BD. Biomechanical accommodation to walking with an ankle-foot prosthesis: An exploratory analysis of novice users with transtibial limb loss within the first year of ambulation. Prosthet Orthot Int. 2022 Oct 1;46(5):452-458. doi: 10.1097/PXR.0000000000000124. Epub 2022 Mar 25.

  PMID: 35333820 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

• Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.

  PMID: 2062970 BACKGROUND

• Hart SG, Staveland LE. Development of NASA-TLX (Task Load Index): Results of Empirical and Theoretical Research. In: Hancock PA, Meshkati N, editors. Advances in Psychology. 52: North-Holland; 1988. p. 139-83.

  BACKGROUND

• Agrawal V, Gailey RS, Gaunaurd IA, O'Toole C, Finnieston A, Tolchin R. Comparison of four different categories of prosthetic feet during ramp ambulation in unilateral transtibial amputees. Prosthet Orthot Int. 2015 Oct;39(5):380-9. doi: 10.1177/0309364614536762. Epub 2014 Jun 12.

  PMID: 24925671 BACKGROUND

• Schmalz T, Blumentritt S, Marx B. Biomechanical analysis of stair ambulation in lower limb amputees. Gait Posture. 2007 Feb;25(2):267-78. doi: 10.1016/j.gaitpost.2006.04.008. Epub 2006 May 24.

  PMID: 16725325 BACKGROUND

• Hunter SW, Frengopoulos C, Holmes J, Viana R, Payne MW. Determining Reliability of a Dual-Task Functional Mobility Protocol for Individuals With Lower Extremity Amputation. Arch Phys Med Rehabil. 2018 Apr;99(4):707-712. doi: 10.1016/j.apmr.2017.12.008. Epub 2018 Jan 6.

  PMID: 29317224 BACKGROUND

• Cho YS, Jang SH, Cho JS, Kim MJ, Lee HD, Lee SY, Moon SB. Evaluation of Validity and Reliability of Inertial Measurement Unit-Based Gait Analysis Systems. Ann Rehabil Med. 2018 Dec;42(6):872-883. doi: 10.5535/arm.2018.42.6.872. Epub 2018 Dec 28.

  PMID: 30613081 BACKGROUND

• Kong XZ, Liu Z, Huang L, Wang X, Yang Z, Zhou G, Zhen Z, Liu J. Mapping Individual Brain Networks Using Statistical Similarity in Regional Morphology from MRI. PLoS One. 2015 Nov 4;10(11):e0141840. doi: 10.1371/journal.pone.0141840. eCollection 2015.

  PMID: 26536598 BACKGROUND

• Tzourio-Mazoyer N, Landeau B, Papathanassiou D, Crivello F, Etard O, Delcroix N, Mazoyer B, Joliot M. Automated anatomical labeling of activations in SPM using a macroscopic anatomical parcellation of the MNI MRI single-subject brain. Neuroimage. 2002 Jan;15(1):273-89. doi: 10.1006/nimg.2001.0978.

  PMID: 11771995 BACKGROUND

• Peterson SM, Ferris DP. Group-level cortical and muscular connectivity during perturbations to walking and standing balance. Neuroimage. 2019 Sep;198:93-103. doi: 10.1016/j.neuroimage.2019.05.038. Epub 2019 May 18.

  PMID: 31112786 BACKGROUND

• Lamb PF, Stockl M. On the use of continuous relative phase: Review of current approaches and outline for a new standard. Clin Biomech (Bristol). 2014 May;29(5):484-93. doi: 10.1016/j.clinbiomech.2014.03.008. Epub 2014 Mar 26.

  PMID: 24726779 BACKGROUND

• Aledda S, Galeoto G, Fabbrini G, Lucibello L, Tofani M, Conte A, Berardi A. A systematic review of the psychometric properties of Quebec user evaluation of satisfaction with assistive technology (QUEST). Disabil Rehabil Assist Technol. 2024 May;19(4):1228-1235. doi: 10.1080/17483107.2022.2161648. Epub 2023 Jan 16.

  PMID: 36645802 BACKGROUND

• Lathouwers E, Tassignon B, Maricot A, Radwan A, Naeyaert M, Raeymaekers H, Van Schuerbeek P, Sunaert S, De Mey J, De Pauw K. Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss. PLoS One. 2024 Mar 21;19(3):e0299869. doi: 10.1371/journal.pone.0299869. eCollection 2024.

  PMID: 38512879 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Artificial Limbs

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment; Orthopedic Equipment

Study Officials

• Kevin De Pauw

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin De Pauw

CONTACT

+32 (0)2 629 27 53; Kevin.De.Pauw@vub.be

Elke Lathouwers

CONTACT

+32 (0)2 629 27 06; Elke.Lathouwers@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: April 18, 2023
• Study Start: January 16, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)