Effect of Observation Plus Imagination of Gait on Stride Variability in Young and Older Adults (OBI)

September 21, 2016 updated by: University Hospital, Angers
The aim of study is to examine the combined effect of observation and imagination of gait on stride time variability of stride time among in healthy young and older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

JUSTIFICATION :

  • In geriatric rehabilitation, gait reeducation, especially after a fall, is often encountered at the very beginning, to the inability to walk again. The main reasons are poorly controlled pain, immobilisations of a segment or the entire lower limb and adaptation to certain prostheses after fracture. This delay in walking recovery leads briefly to acute postural disadaptation that exposes to multiple decubitus complications such as infections, bedsores and muscular atrophy. Conventional rehabilitation techniques are then difficult to implement because they are poorly adapted to the geriatric patients.
  • Today, many experimental data suggest a functional equivalence between making a movement, imagining and observing it. These data can be used to support the development of new rehabilitation techniques. For example, mental imagery is used in the learning of complex movements in order to improve motor performance.
  • Stride variability, and more specifically stride time variability was identified as the best marker of the automatic walking, a low variability corresponding to an automatic and safety gait.
  • We hypothesize that the combined effect of observation and imagination of a gait using an imposed cadency cadency may reduce stride time variability of stride time in healthy young and older adults.

The secondary objectives of the study are as follows:

  • To examine the combined effect of observation and imagination of a gait on mean value of spatio-temporal parameters in healthy young and older adults.
  • To study the influence of age on the combined effect of observation and imagination of gait on mean value and coefficient of variation of spatio-temporal parameters in healthy young and older adults

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Maine et Loire
      • Angers, Maine et Loire, France, 49933 cedex 9
        • Angers University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 20 years
  • Able to walk without walking aid on 15 metres
  • Written informed consent to participate in the study (or trustworthy person)
  • Being affiliated to a social security regime

Exclusion Criteria:

  • Osteoarticular pathologies of the lower limbs and / or spine altering the biomechanical characteristics of the body members.
  • Ataxia
  • History and / or progressive neuropsychiatric disorders.
  • Score in the 4-items Geriatric Depression Scale > 1.
  • Enrolment in another simultaneous clinical trial (Participation in a concomitant clinical trial.)
  • Civil defense measures underway (Measures civil protection type trusteeship / guardianship / safeguarding justice in progress.)
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
15 young patients (<65 years old) and 15 older patients (>64 years old) are submitted to an observation phase and an imagination phase of walking at a precise rythm for 10 minutes
Other: Observation & imagination
It is a combination of an observation phase followed by an immediate imagination phase of a straight gait with an imposed cadency.
Active Comparator: Reading
15 young patients (<65 years old) and 15 older patients (>64 years old) are submitted to a reading phase on a computer for 10 minutes.
Other: Reading
A 10 minutes reading phase of François Mauriac's "Therese Desqueyroux" on a computer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean value of stride time variability
Time Frame: this outcome is assessed at baseline and 10 minutes later.
measured by the coefficient of variation (COV= standard deviation/Average) x 100.
this outcome is assessed at baseline and 10 minutes later.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average value of all spatio-temporal gait parameters and age.
Time Frame: this outcome is assessed at baseline and 10 minutes later.
this outcome is assessed at baseline and 10 minutes later.
Clinical characteristics of participants
Time Frame: this outcome is assessed at baseline.
Age. Gender. Medical and surgical history. Age of acquisition of walking Practice of regular physical activity. Practice of sport. Personal characteristics: weight, size, height of the lower limbs. Number of different therapeutic classes taken per day. Proprioception of lower limb using a graduated diapason (normal maximum score of 8)
this outcome is assessed at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-A00829-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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