NCT02120144

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

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

First Submitted

Initial submission to the registry

March 12, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 22, 2016

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

March 12, 2014

Last Update Submit

September 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean value of stride time variability

    measured by the coefficient of variation (COV= standard deviation/Average) x 100.

    this outcome is assessed at baseline and 10 minutes later.

Secondary Outcomes (2)

  • Average value of all spatio-temporal gait parameters and age.

    this outcome is assessed at baseline and 10 minutes later.

  • Clinical characteristics of participants

    this outcome is assessed at baseline.

Study Arms (2)

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

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.

Other: Reading

Interventions

It is a combination of an observation phase followed by an immediate imagination phase of a straight gait with an imposed cadency.

Intervention
ReadingOTHER

A 10 minutes reading phase of François Mauriac's "Therese Desqueyroux" on a computer

Reading

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, Maine et Loire, 49933 cedex 9, France

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

April 22, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 22, 2016

Record last verified: 2014-03

Locations