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

Обзор

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

Подробное описание

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. Additionally, participants will be asked to fill out the Quebec User Evaluation of Satisfaction with Assistive Technology. 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.

Вмешательства

• Устройство Prosthetic device (Lunaris)
  Participants with an amputation will conduct experiments with the prosthetic device
• Другое No prosthetic device
  Able-bodied individuals will conduct experiments to enable comparison with the participants with amputation
• Устройство Prosthetic device (Sach foot)
  Participants with an amputation will conduct experiments with the prosthetic device

Первичные конечные точки

• Brain neuroplasticity [Срок оценки: Change over 24 weeks]

Вторичные конечные точки (12)

• Performance [Срок оценки: Change over 12 weeks]
• Performance [Срок оценки: Change over 12 weeks]
• Performance [Срок оценки: Change over 12 weeks]
• Performance [Срок оценки: Change over 12 weeks]
• Performance [Срок оценки: Change over 12 weeks]
• Biomechanical [Срок оценки: Change over 12 weeks]
• Biomechanical [Срок оценки: Change over 12 weeks]
• Performance [Срок оценки: Change over 12 weeks]
• Psychological [Срок оценки: Change over 12 weeks]
• Psychological [Срок оценки: Change over 12 weeks]
• Psychological [Срок оценки: Change over 12 weeks]
• Psychological [Срок оценки: Change over 12 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 1 центр

• Vrije Universiteit Brussel — Brussels

Публикации

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

Идентификаторы

NCT: NCT05818410 · EC-2023-089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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