Evaluating Methods to Replicate Stumbles and Slips During Walking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-26

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fall Prevention Balance, Falls Amputation of Lower Limb

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Able-Bodied Individuals Arm Prosthetic Users Arm

Study Groups

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Able-Bodied Individuals Arm

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

Group Type EXPERIMENTAL

Methodologies to induce gait perturbations

Intervention Type OTHER

Method 1: Obstacles deployed at the frond end side of the treadmill Method 2: Obstacles deployed on the side of the treadmill Method 3: Spit-bell treadmill to induce slip perturbations Method 4: String method

Prosthetic Users

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

Group Type EXPERIMENTAL

Methodologies to induce gait perturbations

Intervention Type OTHER

Method 1: Obstacles deployed at the frond end side of the treadmill Method 2: Obstacles deployed on the side of the treadmill Method 3: Spit-bell treadmill to induce slip perturbations Method 4: String method

Interventions

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Methodologies to induce gait perturbations

Method 1: Obstacles deployed at the frond end side of the treadmill Method 2: Obstacles deployed on the side of the treadmill Method 3: Spit-bell treadmill to induce slip perturbations Method 4: String method

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes