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

Vrije Universiteit Brussel

Status: Enrolling

Conditions: Lower Limb Amputation Below Knee (Injury)

Treatments: Other: No prosthetic device; Device: Prosthetic device (Lunaris); Device: Prosthetic device (Sach foot)

Study type: Interventional

Funder types: Other

Identifiers

NCT05818410

EC-2023-089

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

New prosthesis

Experimental group

Description:

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

Treatment:

Device: Prosthetic device (Lunaris)

Standard prosthesis

Active Comparator group

Description:

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

Treatment:

Device: Prosthetic device (Sach foot)

Control group of able-bodied individuals

Other group

Description:

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

Treatment:

Other: No prosthetic device