Evaluating Methods to Replicate Stumbles and Slips During Walking

Össur Iceland ehf

Status: Enrolling

Conditions: Amputation of Lower Limb; Balance, Falls; Fall Prevention

Treatments: Other: Methodologies to induce gait perturbations

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07175714

CIP2024100353

Details and patient eligibility

About

This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations.

Subjects will be divided into two groups: prosthetic users and able-bodied individuals.

Each group will undergo a series of tests where controlled perturbations are applied using up to three methodologies with the number depending on factors such as time and fatigue. These methodologies may include mechanical, visual, or auditory perturbations designed to mimic unexpected obstacles or changes in terrain.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 40 kg < body weight < 136kg
• Cognitive ability to understand all instructions and questionnaires in the study
• Willing and able to participate in the study and following the protocol
• Age ≥ 18 years
• Able to walk independently without the use of assistive device such as a cane or walker
• Able-bodied subjects OR Regular prosthesis users for at least 1 year with unilateral lower limb amputation at or below the transfemoral level (or equivalent level limb deficiency)

Exclusion criteria

• Subjects with pain which can affect their mobility
• Users with socket comfort score less than 7
• Subjects with cognitive impairment
• Pregnant subjects
• Musculoskeletal disorders or neurological conditions that affect motor function, gait or balance
• Use of medications that are known to impair balance and coordination
• Any other conditions deemed by the investigator to make participation unsafe

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Able-Bodied Individuals Arm

Experimental group

Description:

Able-bodied subjects will undergo the same series of gait perturbation tests for comparison of adaptive gait responses.

Treatment:

Other: Methodologies to induce gait perturbations

Prosthetic Users

Experimental group

Description:

Amputee subjects will undergo a series of gait perturbation tests to evaluate adaptive responses.

Treatment:

Other: Methodologies to induce gait perturbations