Lower Limb Amputation Below Knee (Injury)HumanITNCT05818410
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
A study testing Prosthetic device (Lunaris), No prosthetic device and Prosthetic device (Sach foot) in people with Lower Limb Amputation Below Knee (Injury), run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Prosthetic device (Lunaris), No prosthetic device and Prosthetic device (Sach foot)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jan 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral transtibial (below knee) amputation
- Healthy subject
- Medicare Functional Classification Level: K3-4
Who cannot join
- Any neurological disease
- Upper limb or bilateral amputation
- Osso-integration
- Metal implants
- Diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Vrije Universiteit Brussel
Brussels, 1050
Elke Lathouwers, elke.lathouwers@vub.be
About this study
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.
Read the 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. 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.
- Being tested
- Prosthetic device (Lunaris), No prosthetic device, Prosthetic device (Sach foot)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic device (Lunaris)Device
Participants with an amputation will conduct experiments with the prosthetic device
No prosthetic deviceOther
Able-bodied individuals will conduct experiments to enable comparison with the participants with amputation
Prosthetic device (Sach foot)Device
Participants with an amputation will conduct experiments with the prosthetic device
| Study group | Role | What they receive |
|---|---|---|
| New prosthesis | Experimental | 20 participants will be fitted with the Lunaris foot and follow the protocol Receives: Device: Prosthetic device (Lunaris) |
| Standard prosthesis | Active comparator | 20 participants will be fitted with the SACH foot and follow the protocol Receives: 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 Receives: Other: No prosthetic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain neuroplasticity
Brain scan: diffusion-weighted imaging
Measured: Change over 24 weeks
Secondary outcomes (12)
Performance
time (seconds) to complete L-test
Measured: Change over 12 weeks
Performance
time (seconds) to complete dual-L test
Measured: Change over 12 weeks
Performance
time (seconds) to complete slope walking test
Measured: Change over 12 weeks
Performance
time (seconds) to complete stair climbing test
Measured: Change over 12 weeks
Performance
Accuracy of the dual-L-test in percent
Measured: Change over 12 weeks
Biomechanical
Continious relative phase thigh [calculated from the hip \& knee joint angles and velocities]
Measured: Change over 12 weeks
Biomechanical
Continious relative phase knee-ankle calculated from the knee-ankle joint angles and velocities (Lamb et al, 2014)
Measured: Change over 12 weeks
Performance
Distance covered during the 6-minute walk test
Measured: Change over 12 weeks
Psychological
Score on the prosthetic evaluation questionnaire
Measured: Change over 12 weeks
Psychological
Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks
Measured: Change over 12 weeks
Psychological
Borg rating of perceived exertion (score: 6 = No exertion at all , 20 = Maximal exertion)
Measured: Change over 12 weeks
Psychological
Perceived workload: Nasa-Task Load Index (score: 0 = minimal workload, 100 = Maximal perceived workload )
Measured: Change over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start16 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin De Pauw, Vrije Universiteit Brussel
- Investigators
- Kevin De Pauw, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818410
- Sponsor's protocol ID
- EC-2023-089
- Acronym
- HumanIT
- Status last verified
- Feb 2025
- First submitted
- 14 Dec 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30275635Howard 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.
PubMed 29293160Windrich 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.
PubMed 28105948Russell 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.
PubMed 25628378Molina-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.
PubMed 30989836Boone 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.
PubMed 26891238Rogge 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.
PubMed 29959048Rogge 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.
PubMed 28720898Mahon 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.
PubMed 35333820Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Lee 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.
PubMed 2062970Hart 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.
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.
PubMed 24925671Schmalz 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.
PubMed 16725325
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
- ClinicalTrials.gov ID
- NCT05818410
- Acronym / sponsor ID
- HumanIT / EC-2023-089
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.
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. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New prosthesis | Experimental | Device: Prosthetic device (Lunaris)20 participants will be fitted with the Lunaris foot and follow the protocol |
| Standard prosthesis | Active comparator | Device: Prosthetic device (Sach foot)20 participants will be fitted with the SACH foot and follow the protocol |
| Control group of able-bodied individuals | Other | Other: No prosthetic device20 able-bodied individuals will be recruited to enable comparison with both groups of participants with lower limb amputation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral transtibial (below knee) amputation
- Healthy subject
- Medicare Functional Classification Level: K3-4
Key exclusion criteria (5 listed)
- Any neurological disease
- Upper limb or bilateral amputation
- Osso-integration
- Metal implants
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic device (Lunaris)Participants with an amputation will conduct experiments with the prosthetic device | Device | New prosthesis |
| No prosthetic deviceAble-bodied individuals will conduct experiments to enable comparison with the participants with amputation | Other | Control group of able-bodied individuals |
| Prosthetic device (Sach foot)Participants with an amputation will conduct experiments with the prosthetic device | Device | Standard prosthesis |
Primary outcome
Brain neuroplasticity
Time frame: Change over 24 weeks
Brain scan: diffusion-weighted imaging
12 secondary outcomes
Performance
Time frame: Change over 12 weeks
Performance
Time frame: Change over 12 weeks
Performance
Time frame: Change over 12 weeks
Performance
Time frame: Change over 12 weeks
Performance
Time frame: Change over 12 weeks
Biomechanical
Time frame: Change over 12 weeks
Biomechanical
Time frame: Change over 12 weeks
Performance
Time frame: Change over 12 weeks
Psychological
Time frame: Change over 12 weeks
Psychological
Time frame: Change over 12 weeks
Psychological
Time frame: Change over 12 weeks
Psychological
Time frame: Change over 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 30275635Cox 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.
- Background: PubMed 29293160Howard 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.
- Background: PubMed 28105948Windrich 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.
- Background: PubMed 25628378Russell 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.
- Background: PubMed 30989836Molina-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.
- BackgroundBoone DA, Coleman KL. Use of the Prosthesis Evaluation Questionnaire (PEQ). JPO: Journal of Prosthetics and Orthotics. 2006;18(6).
- Background: PubMed 26891238Ozer 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.
- Background: PubMed 29959048Rogge 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.
- Background: PubMed 28720898Rogge 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.
- Background: PubMed 35333820Mahon 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.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 2062970Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin De Pauw principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic device (Lunaris), No prosthetic device and Prosthetic device (Sach foot) in people with Lower Limb Amputation Below Knee (Injury), run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin De Pauw (+32 (0)2 629 27 53, Kevin.De.Pauw@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain neuroplasticity (time frame: Change over 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818410, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.