- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120144
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
A 10 minutes reading phase of François Mauriac's "Therese Desqueyroux" on a computer
|
What is the study measuring?
Primary Outcome Measures
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
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
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
May 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
March 12, 2014
First Submitted That Met QC Criteria
April 17, 2014
First Posted (Estimate)
April 22, 2014
Study Record Updates
Last Update Posted (Estimate)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 21, 2016
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Observation & imagination
-
Centre Hospitalier Régional d'OrléansCompleted
-
Kahramanmaras Sutcu Imam UniversityRecruitingMotor Imagery | Mental Imagery | PARKINSON DISEASE (Disorder)Turkey (Türkiye)
-
The University of Hong KongRecruiting
-
Philipps University MarburgCompletedArachnophobia | Spider FearGermany
-
Centre des Sciences du Goût et de l'AlimentationINSEAD (Institut européen d'administration des affaires)CompletedSensory ImaginationFrance
-
University of PadovaCompletedHoarding Disorder | Virtual Reality Based Therapy | General Population (no Specific Condition or Disease)Italy
-
Philipps University Marburg Medical CenterCompletedHealthy ParticipantsGermany
-
University of Sao Paulo General HospitalUnknown
-
University Medical Center GroningenUniversity of GroningenRecruiting
-
The University of Hong KongCompletedStress | Coping SkillsHong Kong