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Completed

NCT Number: NCT05127993

Comprehensive Evaluation of the Passive Talaris Demonstrator

The passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.

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Key information

Conditions

Lower Limb Amputation Below Knee (Injury) Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Brussel

Brussels, 1050, Belgium

About this study

Twenty-eight healthy active participants with an unilateral transtibial amputation will conduct 2 experimental trials (EXP1 & EXP2) on the same day in a randomized order, i.e. EXP1 with the currently used prosthesis and EXP2 with the passive Talaris Demonstrator. Each experimental trial will include 6 minutes of treadmill walking at 3 different speeds in consecutive blocks of 2 minutes, a slope walking test, a stair climbing test, a L-test and an outdoor walking task.

The six minutes walk test (6MWT) has become one of the most widely used performance-based outcome measures of functional mobility and exercise capacity. Recently, the 6MWT has been found to correlate with single-limb balance time and symmetry of step length in people with amputation. Additionally, the 6MWT distance has been shown to be responsive to functional training interventions in people with lower-limb amputation. Six minutes of treadmill walking at 3 different speeds will be performed. This test will be performed in consecutive blocks of 2 minutes. These consecutive blocks will be walking 2 minutes at self-selected (SS) speed, 2 minutes at 75% of the SS speed and 2 minutes at 125% of the SS speed. These different walking speeds elicit different angular positions of the ankle and activation levels of muscles, and thus might alter the effectiveness of the novel device.

The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position.

The stair climbing test assesses the participants' ability to ascend and descend a staircase (84 cm total height, 3-step staircase with an average rise of 28 cm and run of 18 cm). Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Again, bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg.

The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral transtibial (below knee) amputation
  • Unilateral transfemoral (above knee) amputation
  • Healthy subject
  • Medicare Functional Classification Level: K2-4

Exclusion criteria

  • Any neurological disease
  • Upper limb or bilateral amputation
  • Stump pain or bad fit of the socket

Treatment and study plan

Passive Talaris Demonstrator

Device

The amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics".

Primary outcomes

  1. Performance

    Time frame: Through study completion, a period of 4 months

    Heart rate during all tasks

  2. Performance

    Time frame: Through study completion, a period of 4 months

    Time needed to perform the L-test

  3. Performance

    Time frame: Through study completion, a period of 4 months

    Speed during 6 minutes walk test

  4. Physiological

    Time frame: Through study completion, a period of 4 months

    Electromyography: lower limb muscle activity during different movements (% of the MVC)

  5. Physiological

    Time frame: Through study completion, a period of 4 months

    Oxygen consumption during stair climbing, slope walking and during the 6 minutes walk test

  6. Psychological

    Time frame: Through study completion, a period of 4 months

    Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks

  7. Biomechanical

    Time frame: Through study completion, a period of 4 months

    Joint angels and joint angular velocities of hip, knee and ankle joints

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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