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

Lower Limb Amputation Below Knee (Injury) Clinical Trial

— HumanIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818410
• Other study ID #: EC-2023-089
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Vrije Universiteit Brussel
• Contact: Kevin De Pauw
• Phone: +32 (0)2 629 27 53
• Email: Kevin.De.Pauw[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation Below Knee (Injury)

Intervention

Device:
• Prosthetic device (Lunaris)
Participants with an amputation will conduct experiments with the prosthetic device

Other:
• No prosthetic device
Able-bodied individuals will conduct experiments to enable comparison with the participants with amputation

Device:
• Prosthetic device (Sach foot)
Participants with an amputation will conduct experiments with the prosthetic device

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (21)

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Sci Rep. 2018 Nov 22;8(1):17434. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain neuroplasticity	Brain scan: diffusion-weighted imaging	Change over 24 weeks
Secondary	Performance	time (seconds) to complete L-test	Change over 12 weeks
Secondary	Performance	time (seconds) to complete dual-L test	Change over 12 weeks
Secondary	Performance	time (seconds) to complete slope walking test	Change over 12 weeks
Secondary	Performance	time (seconds) to complete stair climbing test	Change over 12 weeks
Secondary	Performance	Accuracy of the dual-L-test in percent	Change over 12 weeks
Secondary	Biomechanical	Continious relative phase thigh [calculated from the hip & knee joint angles and velocities]	Change over 12 weeks
Secondary	Biomechanical	Continious relative phase knee-ankle calculated from the knee-ankle joint angles and velocities (Lamb et al, 2014)	Change over 12 weeks
Secondary	Performance	Distance covered during the 6-minute walk test	Change over 12 weeks
Secondary	Psychological	Score on the prosthetic evaluation questionnaire	Change over 12 weeks
Secondary	Psychological	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
Secondary	Psychological	Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion)	Change over 12 weeks
Secondary	Psychological	Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload )	Change over 12 weeks