Gait Variability; Elders; Fall; Re-educationOBINCT02120144
Effect of Observation Plus Imagination of Gait on Stride Variability in Young and Older Adults
A study testing Observation & imagination and Reading in people with Gait Variability; Elders; Fall; Re-education, run by University Hospital, Angers at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait Variability; Elders; Fall; Re-education
- What is being tested?
- Observation & imagination and Reading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Nov 2014
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Observation & imagination, Reading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation & imaginationOther
It is a combination of an observation phase followed by an immediate imagination phase of a straight gait with an imposed cadency.
ReadingOther
A 10 minutes reading phase of François Mauriac's "Therese Desqueyroux" on a computer
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: Observation & imagination |
| Reading | Active comparator | 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. Receives: Other: Reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value of stride time variability
measured by the coefficient of variation (COV= standard deviation/Average) x 100.
Measured: this outcome is assessed at baseline and 10 minutes later.
Secondary outcomes (2)
Average value of all spatio-temporal gait parameters and age.
Measured: this outcome is assessed at baseline and 10 minutes later.
Clinical characteristics of participants
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)
Measured: this outcome is assessed at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Variability; Elders; Fall; Re-educationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120144
- Sponsor's protocol ID
- 2013-A00829-36
- Acronym
- OBI
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Observation Plus Imagination of Gait on Stride Variability in Young and Older Adults
- ClinicalTrials.gov ID
- NCT02120144
- Acronym / sponsor ID
- OBI / 2013-A00829-36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Observation & imagination15 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 |
| Reading | Active comparator | Other: Reading15 young patients (<65 years old) and 15 older patients (>64 years old) are submitted to a reading phase on a computer for 10 minutes. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
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 |
|---|---|---|
| Observation & imaginationIt is a combination of an observation phase followed by an immediate imagination phase of a straight gait with an imposed cadency. | Other | Intervention |
| ReadingA 10 minutes reading phase of François Mauriac's "Therese Desqueyroux" on a computer | Other | Reading |
Primary outcome
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.
2 secondary outcomes
Average value of all spatio-temporal gait parameters and age.
Time frame: this outcome is assessed at baseline and 10 minutes later.
Clinical characteristics of participants
Time frame: this outcome is assessed at baseline.
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 22 Sep 2016.
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 Observation & imagination and Reading in people with Gait Variability; Elders; Fall; Re-education, run by University Hospital, Angers at 1 site in France.
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 4 inclusion and 7 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 22 Sep 2016. 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 France. 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?
Mean value of stride time variability (time frame: this outcome is assessed at baseline and 10 minutes later.). 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 22 Sep 2016.