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Recruiting NCT07175714

Evaluating Methods to Replicate Stumbles and Slips During Walking

No phase Interventional Fall Prevention Balance, Falls Amputation of Lower Limb

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methodologies to induce gait perturbations.
Who it may be relevant to
Registry conditions: Fall Prevention, Balance, Falls, Amputation of Lower Limb. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iceland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Effectiveness of Gait Perturbation Methods in Inducing Stumble or Fall Events [Time frame: For each gait perturbation method, events are assessed during its application within a single testing session (approximately 30-60 minutes); multiple methods may be tested per session.]
  • Subjective Evaluation of Gait Perturbation Methodologies [Time frame: Participant feedback is collected immediately after each gait perturbation method within a single testing session (approximately 30-60 minutes); multiple methods may be evaluated per session.]
  • Safety Perception of Gait Perturbation Methodologies [Time frame: Participant feedback is collected immediately after each gait perturbation method within a single testing session (approximately 30-60 minutes); multiple methods may be evaluated per session.]
  • Unpredictability of Gait Perturbation Methodologies [Time frame: Participant feedback is collected immediately after each gait perturbation method within a single testing session (approximately 30-60 minutes); multiple methods may be evaluated per session.]
  • Consistency of Gait Perturbation Incidence Rates Over Time [Time frame: For each gait perturbation method, events are assessed during its application within a single testing session (approximately 30-60 minutes); multiple methods may be tested per session.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Iceland · 2 centers
  • University of Iceland — Reykjavik
  • Össur Iceland ehf. — Reykjavik

Identifiers

NCT: NCT07175714 · CIP2024100353

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗