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

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

Detailed Description
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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.

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

Conditions
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Lower Limb Amputation Below Knee (Injury)

Intervention / Treatment
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* Device: Prosthetic device (Lunaris)
* Other: No prosthetic device
* Device: Prosthetic device (Sach foot)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New prosthesis<br>20 participants will be fitted with the Lunaris foot and follow the protocol | Device: Prosthetic device (Lunaris)<br>* Participants with an amputation will conduct experiments with the prosthetic device<br>|
| Active Comparator: Standard prosthesis<br>20 participants will be fitted with the SACH foot and follow the protocol | Device: Prosthetic device (Sach foot)<br>* Participants with an amputation will conduct experiments with the prosthetic device<br>|
| Other: Control group of able-bodied individuals<br>20 able-bodied individuals will be recruited to enable comparison with both groups of participants with lower limb amputation | Other: No prosthetic device<br>* Able-bodied individuals will conduct experiments to enable comparison with the participants with amputation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain neuroplasticity | Brain scan: diffusion-weighted imaging | Change over 24 weeks | 

Secondary Outcome Measures

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