Instrumental Analysis of Walking in People With Osseointegrated Prostheses for Lower Extremity Amputation: Comparative Evaluation With Traditional Socket Prostheses

NCT ID: NCT04934839

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2024-12-31

Brief Summary

The currently accepted standard for rehabilitation and mobility following amputation is a socket-mounted prosthesis. Osseointegration is an alternative method that has gradually gained greater acceptance in the last 30 years. It is defined as a procedure in which a metal implant is directly anchored to the residual bone, attached to a prosthetic limb using a transcutaneous connector.

The advantages of osseointegrated prostheses over conventional socket prostheses include stable fixation, significant increases in walking ability, range of motion and control of the prosthesis, and health-related quality of life. Moreover, bodyweight distribution results more similar to physiological conditions.

No formal consensus exists for osseointegration surgery. However, based on the positive clinical experience, surgeons currently indicate this surgery for those patients who show poor tolerance of socket prostheses.

The present study investigates neuro-physiologic and mechanical parameters of walking and balance in patients with lower limb amputation and osseointegrated prostheses and in matched patients with traditional socket prostheses to highlight strengths and weaknesses of the alternative technique with respect to the present standard of care.

The primary endpoint is the investigation of the neurologic and mechanic adaptation in terms of a) kinematic and dynamic segmental analysis of walking and transfer of the body center of mass during walking; b) capacity to retain balance in response to different conditions of oscillation, tilt, and translation of a posturographic platform.

The secondary endpoint is investigating of adaptation to walking on a split-belt treadmill mounted on force sensors with the belts running at different velocities.

We hypothesize that:

• the deficit in joint power of the prosthetic limb is associated with a phenomenon of "learned non-use" both in balance and during gait. This behavior looks automatic and unconscious. It consists of the under recruitment of the impaired side as a form of unconscious protection, which is adopted when the contralateral side may be exploited to carry out the function;
• the joint power provided by the prosthetic limb may increase both by increasing treadmill velocity and by walking in split-belt modality with the prosthetic limb on the faster belt;
• an "after-effect" will be evidenced after the split-belt walking test when the two belts will return to the same velocity; patients with osseointegrated prostheses and patients with socket prostheses may show different behaviors in the adaptation to split-belt walking and the following post-adaptation, as a result of the residual proprioception of the amputated limb.

Results from the present study will allow:

• the identification of the possible advantages in walking and balance symmetry in patients with osseointegrated prostheses with respect to patients with socket prostheses;
• the estimate of the sample size for future experimental protocols and new rehabilitative programs.

Conditions

Lower Extremity Amputation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with osseointegrated prostheses

Patients with an osseointegrated prosthesis following a lower limb amputation

Group Type: EXPERIMENTAL

Test of standing balance (Equitest System). Test of walking in tied and split conditions on a force-sensorized split-belt treadmill.

Intervention Type: DIAGNOSTIC_TEST

Tests of standing balance will be performed using the EquiTest System posturographic platform. Individuals will be requested to perform three tasks within the EquiTest battery: Sensory Organization test, Motor Control test backward/forward, Adaptation Test upward/downward.

Gait analysis will be performed on a force sensorized split-belt treadmill. Participants will walk at increasing velocities from 0.2 m/s to the highest sustainable velocity in tied-belt condition. Velocity will be increased by 0.1 m/s every 20 consecutive strides.

During gait analysis in the split-belt condition, participants will walk for 30 seconds with both belts at 0.4 m/s. Then, the velocity of the belt under the prosthetic limb will be increased to 1.2 m/s. After 6 minutes, the velocity of the faster belt will be restored at 0.4 m/s for 6 more minutes. Different combinations of velocities could be tested based on the patients' characteristics, maintaining a ratio of 3:1 between the velocities of the 2 belts.

Patients with socket prostheses

Patients with a socket-mounted prosthesis following a lower limb amputation

Group Type: EXPERIMENTAL

Test of standing balance (Equitest System). Test of walking in tied and split conditions on a force-sensorized split-belt treadmill.

Intervention Type: DIAGNOSTIC_TEST

Tests of standing balance will be performed using the EquiTest System posturographic platform. Individuals will be requested to perform three tasks within the EquiTest battery: Sensory Organization test, Motor Control test backward/forward, Adaptation Test upward/downward.

Gait analysis will be performed on a force sensorized split-belt treadmill. Participants will walk at increasing velocities from 0.2 m/s to the highest sustainable velocity in tied-belt condition. Velocity will be increased by 0.1 m/s every 20 consecutive strides.

During gait analysis in the split-belt condition, participants will walk for 30 seconds with both belts at 0.4 m/s. Then, the velocity of the belt under the prosthetic limb will be increased to 1.2 m/s. After 6 minutes, the velocity of the faster belt will be restored at 0.4 m/s for 6 more minutes. Different combinations of velocities could be tested based on the patients' characteristics, maintaining a ratio of 3:1 between the velocities of the 2 belts.

Interventions

Test of standing balance (Equitest System). Test of walking in tied and split conditions on a force-sensorized split-belt treadmill.

Tests of standing balance will be performed using the EquiTest System posturographic platform. Individuals will be requested to perform three tasks within the EquiTest battery: Sensory Organization test, Motor Control test backward/forward, Adaptation Test upward/downward.

Gait analysis will be performed on a force sensorized split-belt treadmill. Participants will walk at increasing velocities from 0.2 m/s to the highest sustainable velocity in tied-belt condition. Velocity will be increased by 0.1 m/s every 20 consecutive strides.

During gait analysis in the split-belt condition, participants will walk for 30 seconds with both belts at 0.4 m/s. Then, the velocity of the belt under the prosthetic limb will be increased to 1.2 m/s. After 6 minutes, the velocity of the faster belt will be restored at 0.4 m/s for 6 more minutes. Different combinations of velocities could be tested based on the patients' characteristics, maintaining a ratio of 3:1 between the velocities of the 2 belts.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• unilateral lower extremity amputation;
• age > 18 years;
• amputation-adjusted Body Mass Index between 18 and 25;
• ability to understand the instructions;
• ability to wittingly sign the informed consent form.

Exclusion Criteria

• other previous knee injuries or major surgical interventions at the lower limbs;
• comorbidities, such as neurological conditions, vascular diseases, or diseases of orthopedic, cardiac, or pulmonary origin;
• cancer disease in the site under examination;
• other neurological pathologies with impact on balance and gait.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASST Gaetano Pini-CTO

OTHER

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Tesio, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

Istituto Auxologico Italiano

Milan, MI, Italy

Site Status: RECRUITING

ASST Gaetano Pini-CTO

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luigi Tesio, MD, Professor

Role: CONTACT

l.tesio@auxologico.it

+39 02 58218151

Stefano Scarano, MD, Research Fellow

Role: CONTACT

s.scarano@auxologico.it

+39 02 58218717

Facility Contacts

Stefano Scarano, MD, Research Fellow

Role: primary

s.scarano@auxologico.it

+39 02 58218717

Pietro Simone Randelli, MD, Professor

Role: primary

pietro.randelli@unimi.it

Alessandra Menon

Role: backup

alessandra.menon@asst-pini-cto.it

Other Identifiers

24X101

Identifier Type: -

Identifier Source: org_study_id