NCT01146249

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

13.1 years

First QC Date

April 28, 2010

Last Update Submit

November 29, 2023

Conditions

Keywords

Multisensorial integrationPostural controlVisual reliance

Outcome Measures

Primary Outcomes (1)

  • Sensory profile before and after rehabilitation

    Sensory profile is defined by change in postural control on force plate under, visual, vestibular, and proprioceptive stimulation.

    at month 1

Secondary Outcomes (15)

  • DISEANESS Handicap Inventory scale

    at month 1

  • Activities-specific Balance Confidence scale

    at month 1

  • Berg Balance scale

    at month 1

  • Sensory profile before and after rehabilitation

    at month 6

  • Berg Balance scale

    at month 6

  • +10 more secondary outcomes

Study Arms (5)

1: healthy subject

Other: Balance assessment under sensory stimulation

3: post stroke patients

Other: Balance assessment under sensory stimulation

2: vestibular patients

Vestibular patients with a unique history of peripheric vestibular disorder

Other: Balance assessment under sensory stimulation

4: ataxic patients

Patient with proprioception disorder related to peripheral neuropathy

Other: 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

Interventions

Balance assessment under sensory stimulation

1: healthy subject2: vestibular patients3: post stroke patients4: ataxic patients5: Old fallers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • For each category, other disorder than the one studied leading to balance trouble.
  • Neuropsychological troubles preventing comprehension of the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de MPR - Hôpital Lariboisière - Fernand Widal

Paris, 75010, France

Location

Study Officials

  • Isabelle BONAN, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

June 17, 2010

Study Start

November 26, 2007

Primary Completion

December 18, 2020

Study Completion

December 18, 2020

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations