Evaluation of the Sensorial Preference (PREFSENSOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01146249
First received: April 28, 2010
Last updated: June 16, 2010
Last verified: April 2010
  Purpose

Among the components of postural control, sensorial integration is of crucial importance. The most important sensorial inputs for postural maintenance are the vestibular system which provides information regarding accelerations of the head in space (HORAK 1994), the somatosensory system which provides proprioceptive information that are used to determine changes in body position (INGLIS 1994) and the visual system which provides information for self motion in the environment. The receptors and the integration channel of each sensorial system have inner characteristics which lead to different performance of the different input in regards to the task and the environmental context (FITZGERALD 1994). Most of time, sensorial information are congruent but sometimes they are conflicted. This is the case when being in a stationary train, the train beside going on, giving the illusory sensation of movement even if the vestibular system is not activated. A sensory weighting process is then necessary for subjects to control balance. The Central Nervous System (CNS) is thought to adjust the relative contribution of sensory input to control stance depending on environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002, KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide postural stability. Nevertheless the interconnection of the multiple sensorial feedback involved in the postural control is not yet completely understood (CHIARI 2000).

Today, there is no tool available to evaluate the individual use of the sensorial information to postural control. It seems interesting to have such a tool to better understand the sensorial preference of subjects. It would be of particular importance for patients with various pathologies in the aim to design individualized balance rehabilitation programs.

The aim of the study was to test a tool built to evaluate the sensorial preference of subjects by studying their postural reaction related to the 3 main sensorial perturbations. Normal subjects will be first tested to assess the repeatability of the protocol and to collect normal values. Then, patients with post stroke hemiplegia, vestibular disease, neuropathy and fallers will be studied in order to test the feasibility of the protocol and to have preliminary data of sensorial preference among these populations.


Condition Intervention
Balance
Other: Balance assessment under sensory stimulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Sensorial Preference for Balance Control

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Sensory profile before and after rehabilitation [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
    Sensory profile is defined by change in postural control on force plate under, visual, vestibular, and proprioceptive stimulation.


Secondary Outcome Measures:
  • DISEANESS Handicap Inventory scale [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence scale [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
  • Berg Balance scale [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
    Balance assessment

  • Sensory profile before and after rehabilitation [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Sensory profile is defined by change in postural control on force plate under, visual, vestibular, and proprioceptive stimulation.

  • Berg Balance scale [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Balance assessment

  • Timed up and go [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
    Balance assessment

  • Timed up and go [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Balance assessment

  • Walking distance [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
    Balance assessment

  • Walking distance [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Balance assessment

  • Speed of walk [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
    Balance assessment

  • Speed of walk [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Balance assessment

  • Area and length of the center of pression displacement during 10sec. open eyes [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
    Balance assessment

  • Area and length of the center of pression displacement during 10sec. open eyes [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Balance assessment

  • Area and length of the center of pression displacement during 10sec, closed eyes (assessed during the sensorial tests) [ Time Frame: at month 1 ] [ Designated as safety issue: No ]
    Balance assessment

  • Area and length of the center of pression displacement during 10sec, closed eyes (assessed during the sensorial tests) [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    Balance assessment


Estimated Enrollment: 125
Study Start Date: November 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1: healthy subject
NA
Other: Balance assessment under sensory stimulation
Balance assessment under sensory stimulation
3: post stroke patients
NA
Other: Balance assessment under sensory stimulation
Balance assessment under sensory stimulation
2: vestibular patients
Vestibular patients with a unique history of peripheric vestibular disorder
Other: Balance assessment under sensory stimulation
Balance assessment under sensory stimulation
4: ataxic patients
Patient with proprioception disorder related to peripheral neuropathy
Other: Balance assessment under sensory stimulation
Balance assessment under sensory stimulation
5: Old fallers
Old subjects with a history of falls (one or more during the last year)
Other: Balance assessment under sensory stimulation
Balance assessment under sensory stimulation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy subjects Vestibular patients Post stroke patients Patient with proprioception disorder Old subjects with a history of falls

Criteria

Inclusion Criteria: depending on the group

  • Healthy subjects without history of balance disorder
  • Vestibular patients with a unique history of peripheric vestibular disorder
  • Post stroke patients after a unique hemispheric stroke, being able to stand without any help
  • Patient with proprioception disorder related to peripheral neuropathy.
  • Old subjects with a history of falls (one or more during the last year).

Exclusion Criteria:

  • For each category, other disorder than the one studied leading to balance trouble.
  • Neuropsychological troubles preventing comprehension of the tests.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146249

Contacts
Contact: Isabelle BONAN, MD,PhD 33-1-40-05-42-05 isabelle.bonan@lrb.aphp.fr
Contact: Alain YELNIK, MD 33-1-40-05-42-05 alain.yelnik@lrb.aphp.fr

Locations
France
Service de MPR - Hôpital Lariboisière - Fernand Widal Recruiting
Paris, France, 75010
Contact: Alain YELNIK, MD    33-1-40-05-42-05    alain.yelnik@lrb.aphp.fr   
Contact: Florence COLLE, MD    33-1-40-05-42-05    f.colle@ch-sainte-anne.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Isabelle BONAN, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Yannick Vacher, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT01146249     History of Changes
Other Study ID Numbers: P070401, 2007-A00410-53
Study First Received: April 28, 2010
Last Updated: June 16, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multisensorial integration
Postural control
Visual reliance

ClinicalTrials.gov processed this record on August 20, 2014