Balance DisordersNCT03813004
Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults
A study testing Reaction for gait perturbation in people with Balance Disorders, run by Barbara Łysoń at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Disorders
- What is being tested?
- Reaction for gait perturbation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 sitePoland
- Study dates
- 25 Feb 2018to 20 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-35
- female or male
- good health condition
Who cannot join
- lower limb injuries (last 6 months)
- head injuries (last 6 months)
- diseases of the vestibular system
- serious eye defects
- extreme sports athletes
Trial locations and contacts
1 site in 1 country.
Poland1 site
Józef Piłsudski University of Physical Education in Warsaw
Warsaw, Mazowsze, 00-968
About this study
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.
- Conditions
- Balance Disorders
- Being tested
- Reaction for gait perturbation
- Keywords
- motek grail, balance, gait perturbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reaction for gait perturbationDiagnostic test
Participants were subjected to four different perturbation types while walking on the treadmill:
- left treadmill belt deceleration for right leg toe off
- right treadmill belt deceleration for left leg toe off
- left treadmill belt acceleration for right leg heel strike
- right treadmill belt acceleration for left leg heel strike
Motion analysis was conducted to analyze effect of the intervention on gait.
| Study group | Role | What they receive |
|---|---|---|
| Young healthy adults | Experimental | Not described Receives: Diagnostic Test: Reaction for gait perturbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motek Grail output (joint angles)
Joint angles calculated using HBM Gait model [degrees]
Measured: 40 minutes
Motek Grail output (joint moments)
Joint moments calculated using HBM Gait model [Newton*meter/kilogram]
Measured: 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]
Measured: 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]
Measured: 40 minutes
Body composition
Body composition using Tanita Body Composition Monitor (fat tissue percentage, muscle mass percentage, water percentage)
Measured: 10 minutes
Range of movement
Range of movement in hip, knee and ankle joint, measured using SFTR system [degrees]
Measured: 20 minutes
Height
Height measured in meters
Measured: 2 minutes
Weight
Weight measured in kilograms
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start25 Feb 2018
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Łysoń
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Barbara Łysoń, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813004
- Sponsor's protocol ID
- DS-311
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults
- ClinicalTrials.gov ID
- NCT03813004
- Acronym / sponsor ID
- DS-311
- Conditions
- Balance Disorders
- Keywords
- motek grail, balance, gait perturbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Barbara ŁysońUniversity, hospital or other
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young healthy adults | Experimental | Diagnostic Test: Reaction for gait perturbation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-35
- female or male
- good health condition
Key exclusion criteria (5 listed)
- lower limb injuries (last 6 months)
- head injuries (last 6 months)
- diseases of the vestibular system
- serious eye defects
- extreme sports athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reaction for gait perturbationParticipants 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. | Diagnostic test | Young healthy adults |
Primary outcome
Motek Grail output (joint angles)
Time frame: 40 minutes
Joint angles calculated using HBM Gait model [degrees]
Motek Grail output (joint moments)
Time frame: 40 minutes
Joint moments calculated using HBM Gait model [Newton*meter/kilogram]
Motek Grail output (ground reaction forces)
Time frame: 40 minutes
Ground reaction forces calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot [Newtons]
Motek Grail output (centre of pressure)
Time frame: 40 minutes
Center of pressure calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot [meters]
Body composition
Time frame: 10 minutes
Body composition using Tanita Body Composition Monitor (fat tissue percentage, muscle mass percentage, water percentage)
Range of movement
Time frame: 20 minutes
Range of movement in hip, knee and ankle joint, measured using SFTR system [degrees]
Height
Time frame: 2 minutes
Height measured in meters
Weight
Time frame: 2 minutes
Weight measured in kilograms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reaction for gait perturbation in people with Balance Disorders, run by Barbara Łysoń at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motek Grail output (joint angles) (time frame: 40 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.