NCT03813004

Brief Summary

Investigators would like to examine, what are strategies for balance recovery in gait perturbations. Different perturbation types where used in the current study. The study involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that research including young healthy adults would help to elaborate fall prevention program for seniors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

January 7, 2019

Last Update Submit

January 18, 2019

Conditions

Keywords

motek grailbalancegait perturbation

Outcome Measures

Primary Outcomes (8)

  • Motek Grail output (joint angles)

    Joint angles calculated using HBM Gait model \[degrees\]

    40 minutes

  • Motek Grail output (joint moments)

    Joint moments calculated using HBM Gait model \[Newton\*meter/kilogram\]

    40 minutes

  • Motek Grail output (ground reaction forces)

    Ground reaction forces calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot \[Newtons\]

    40 minutes

  • Motek Grail output (centre of pressure)

    Center of pressure calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot \[meters\]

    40 minutes

  • Body composition

    Body composition using Tanita Body Composition Monitor (fat tissue percentage, muscle mass percentage, water percentage)

    10 minutes

  • Range of movement

    Range of movement in hip, knee and ankle joint, measured using SFTR system \[degrees\]

    20 minutes

  • Height

    Height measured in meters

    2 minutes

  • Weight

    Weight measured in kilograms

    2 minutes

Study Arms (1)

Young healthy adults

EXPERIMENTAL
Diagnostic Test: Reaction for gait perturbation

Interventions

Participants were subjected to four different perturbation types while walking on the treadmill: 1. left treadmill belt deceleration for right leg toe off 2. right treadmill belt deceleration for left leg toe off 3. left treadmill belt acceleration for right leg heel strike 4. right treadmill belt acceleration for left leg heel strike Motion analysis was conducted to analyze effect of the intervention on gait.

Young healthy adults

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-35
  • female or male
  • good health condition

You may not qualify if:

  • lower limb injuries (last 6 months)
  • head injuries (last 6 months)
  • diseases of the vestibular system
  • serious eye defects
  • extreme sports athletes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Józef Piłsudski University of Physical Education in Warsaw

Warsaw, Mazowsze, 00-968, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 23, 2019

Study Start

February 25, 2018

Primary Completion

June 20, 2018

Study Completion

June 20, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations