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Prismatic Adaptation for Rehabilitation of Postural Imbalance After Stroke (PEQUIE)

Primary Purpose

Chronic Right Supratensorial Stroke Patients

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

The prismatic adaptation (PA)

The sham prismatic adaptation (S-PA)

About this trial

This is an interventional other trial for Chronic Right Supratensorial Stroke Patients focused on measuring Stroke, hemiplegia, rehabilitation, prismatic adaptation, postural imbalance, posture, spatial cognition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult, over 18 years old, and less than 80 years old
Stroke
- right
- supratensorial,
- unilateral,
- haemorrhagic or ischemic,
- chronic (over 12 months)
Ability to stay over 30 seconds in standing static position with open eyes and close eyes
Show a postural imbalance, determined by a body weight bearing on right lower limb ≥ 60% during at least one posturographic evaluation with open eyes and that requires an inpatient rehabilitation
Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
Free, enlightened and written consent of the patient

Exclusion Criteria:

Cerebellar lesion
Brainstem lesion
Bilateral cerebral lesion
All orthopaedic or rheumatologic diseases, retinal visual impairments or other diseases interfering with assessments in accordance with the investigator's judgment
Pregnancy or breast feeding
Under an administrative or legal supervision

Sites / Locations

CHU Grenoble
Hôpital Henry Gabrielle, service de médecine physique et réadaptationRecruiting
CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prismatic adaptation (PA) group

Sham group

Arm Description

Patients in the experimental group will benefit from 10 sessions of adaptation prismatic (PA) by means of one daily session of 20 minutes (5 times by week; 2 weeks), performed by an experienced physical therapist or occupational therapist. All patients will also benefit from conventional rehabilitation (Standard physical therapy, standard occupational therapy, standard speech therapy …) according to the needs of the patients.

Patients in the sham group will benefit from 10 sessions of sham adaptation prismatic (S-PA) by means of one daily session of 20 minutes (5 times by week; 2 weeks), performed by an experienced physical therapist or occupational therapist. All patients will also benefit from conventional rehabilitation (Standard physical therapy, standard occupational therapy, standard speech therapy …) according to the needs of the patients.

Outcomes

Primary Outcome Measures

Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS)

Balance : The inter-group difference of within-group changes for the Berg Balance Scale (BBS) Score between 0 and 56 points

Secondary Outcome Measures

Balance: the inter-group difference of within-group changes for the Berg Balance Scale (BBS)

Change from baseline (mean of the 2 pre-tests) at one month after the end of treatment (M+1) (1 month and 2 weeks about after the baseline) and at three months after the end of treatment (M+3) (3 month and 2 weeks about after the baseline) Score between 0 and 56 points.

Balance: The inter-group difference of within-group changes for standing static posturographic variables

Satnding posturographic variables include mediolateral and anteroposterior deviation of center of pression (COP), mediolateral and anteroposteriorvariability of COP, sway area of COP, body weight bearing on each lower limb. The mediolateral and anteroposterior deviations of COP measured in millimeters, the sway area of COP calculated in square millimeters, the mediolateral and anteroposterior variability of COP calculated as the standard deviation of the mediolateral and anteroposterior deviations of COP, body weight bearing on each lower limb measured in percent of total weight bearing.

Lateropulsion: The inter-group difference of within-group changes for the Scale for Contraversive Pushing (SCP)

Score between 0 and 6 points

The inter-group difference of within-group changes for each spatial reference frame (MSSA, VSSA, OLP, LBA)

Spatial reference frames include the measurement of the manual subjective straight aheaed (MSSA), the visual subjective straight ahead (VSSA), open-loup pointing without visual feedback (OLP), the subjective longitudinal body axis (LBA) Angular deviation measured in degrees

Autonomy : Inter-group difference of within-group changes for the Barthel index (BI)

Score between 0 and 100 points

Additionnal descriptive anatomic study of cerebral lesions using diffusion tensor Magnetic Resonance Imaginig (MRI) (Tractography)

To determine the location of the cerebral lesion, the size of cerebral lesion and to quantify the severity of the disconnection (after tractography reconstructions of white matter pathways).

Relationship between prismatic adaptation induced changes on misperceptions of spatial reference frames and these on postural and balance disorders

Statistical correlations between changes (before versus after intervention) on Berg Balance Scale (BBS), postural disorders (i.e. Weight Beainf Asymetry (WBA), body sway, and lateropulsion), and spatial reference frames.

Full Information

NCT ID

NCT03154138

First Posted

May 12, 2017

Last Updated

March 28, 2022

Sponsor

Hospices Civils de Lyon

Collaborators

Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France, Université Claude Bernard Lyon 1 (UCBL), Equipe " ImpAct Trajectoires " du Centre de Recherche en Neurosciences de Lyon (CRNL)

1. Study Identification

Unique Protocol Identification Number

NCT03154138

Brief Title

Prismatic Adaptation for Rehabilitation of Postural Imbalance After Stroke

Acronym

PEQUIE

Official Title

Assessment of the Rehabilitation of Postural Imbalance After Chronic Right Supratensorial Stroke by Prismatic Adaptation: Multicentric Randomised Sham-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 4, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Postural imbalance after stroke leads to limitations of activity and a worse autonomy. The postural imbalance is increased in right supratensorial stroke (RSS) compared to left supratensorial stroke. The evidences for the rehabilitation of postural imbalance are weak. Likewise, disorders of spatial reference frames are increased in RSS. The postural imbalance is correlated with the disorders of spatial reference frames in RSS patients. Prismatic adaptation (PA) is often used for the rehabilitation of unilateral spatial neglect after RSS. Several studies have demonstrated a peculiar expansion of sensorimotor after-effects to spatial cognition. An immediate effect of reduction in postural imbalance have been showed in acute RSS. Therefore, it is interested to investigate the immediate and delayed effects of PA on the postural balance and the spatial reference frames in chronic RSS to purpose a new therapeutic approach. The hypothesis of the study is that PA would improve the postural balance (activity) of chronic RSS patients by a reduction in mediolateral postural asymmetry, resulting from a " bottom-up " action of PA on spatial reference frames.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Right Supratensorial Stroke Patients

Keywords

Stroke, hemiplegia, rehabilitation, prismatic adaptation, postural imbalance, posture, spatial cognition

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prismatic adaptation (PA) group

Arm Type

Experimental

Arm Description

Arm Title

Sham group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

The prismatic adaptation (PA)

Intervention Description

Prismatic adaptation (PA) is based on the wearing of a pair of glasses producing a visual field deviation of 10° to rightward. While wearing theses glasses, the patient is asked to perform fast pointing movements towards targets by the right hand. Targets are symmetrical located at 10° in the right and left side in front of the patient. The order of pointing between these two targets is pseudo-randomly by the therapist. At the beginning of the exposure, the patient performs pointing movements with a shift toward the right side (initial errors consecutive to the prism deviation). Taking into account theses errors, the patient then compensates the optical deviation. After removing the prismatic glasses, the asked pointing movement to the targets is once again shifted but to the left side this time (after-effects attesting the prismatic adaptation)

Intervention Type

Device

Intervention Name(s)

The sham prismatic adaptation (S-PA)

Intervention Description

The sham prismatic adaptation (S-PA) is based on the wearing of a pair of glasses producing no visual field deviation. Theses sham glasses is identical with theses used in PA group without the optical deviation. The conditions are similar with theses in the PA group. The procedure with the sham glasses are similar with these one used in the PA group: While wearing the sham glasses, the patient is asked to perform fast pointing movements towards targets by the right hand. Targets are symmetrical located at 10° in the right and left side in front of the patient. The support with targets are the same as these one used in the PA group. The order of pointing between these two targets is pseudo-randomly by the therapist. At the beginning of the exposure, the patient performs pointing movements without shift. No compensation of movement is observed. After removing the prismatic glasses, the asked pointing movement to the targets is not shifted (No after-effects observed)

Primary Outcome Measure Information:

Title

Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS)

Description

Balance : The inter-group difference of within-group changes for the Berg Balance Scale (BBS) Score between 0 and 56 points

Time Frame

Change from baseline (mean of the 2 pre-tests) at 7 days after the end of treatment (3 weeks about after the baseline)

Secondary Outcome Measure Information:

Title

Balance: the inter-group difference of within-group changes for the Berg Balance Scale (BBS)

Description

Time Frame

Change from baseline at 1 month after the end of treatment

Title

Balance: The inter-group difference of within-group changes for standing static posturographic variables

Description

Time Frame

Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment

Title

Lateropulsion: The inter-group difference of within-group changes for the Scale for Contraversive Pushing (SCP)

Description

Score between 0 and 6 points

Time Frame

Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment.

Title

The inter-group difference of within-group changes for each spatial reference frame (MSSA, VSSA, OLP, LBA)

Description

Time Frame

Change from baseline at +2 Hours, Day 3, Day 7, Month 1 and Month 3 after the end of treatment

Title

Autonomy : Inter-group difference of within-group changes for the Barthel index (BI)

Description

Score between 0 and 100 points

Time Frame

Change from baseline (pre-test) at Day7, Month +1 and Month +3 after the end of treatment.

Title

Additionnal descriptive anatomic study of cerebral lesions using diffusion tensor Magnetic Resonance Imaginig (MRI) (Tractography)

Description

To determine the location of the cerebral lesion, the size of cerebral lesion and to quantify the severity of the disconnection (after tractography reconstructions of white matter pathways).

Time Frame

Before the starting of the intervention, during the pre-tests.

Title

Relationship between prismatic adaptation induced changes on misperceptions of spatial reference frames and these on postural and balance disorders

Description

Time Frame

+2Hours, Day+3, Day+7, Month+1 and Month+3.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult, over 18 years old, and less than 80 years old Stroke right supratensorial, unilateral, haemorrhagic or ischemic, chronic (over 12 months) Ability to stay over 30 seconds in standing static position with open eyes and close eyes Show a postural imbalance, determined by a body weight bearing on right lower limb ≥ 60% during at least one posturographic evaluation with open eyes and that requires an inpatient rehabilitation Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research Free, enlightened and written consent of the patient Exclusion Criteria: Cerebellar lesion Brainstem lesion Bilateral cerebral lesion All orthopaedic or rheumatologic diseases, retinal visual impairments or other diseases interfering with assessments in accordance with the investigator's judgment Pregnancy or breast feeding Under an administrative or legal supervision

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aurélien HUGUES, PhD

Phone

0637054040

Ext

+33

huguesaurelien@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

RODE RODE, MD

Phone

0478865066

Ext

+33

gilles.rode@chu-lyon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amandine GUINET-LACOSTE, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Grenoble

City

Grenoble

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DOMINIC PERENNOU, MD

Phone

04 76 76 60 85

Ext

+33

dperennou@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

DOMINIC PERENNOU, MD

Facility Name

Hôpital Henry Gabrielle, service de médecine physique et réadaptation

City

Saint-Genis-Laval

ZIP/Postal Code

69230

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aurélien HUGUES, PhD

Phone

(0)6 37 05 40 40

Ext

+33

huguesaurelien@gmail.com

First Name & Middle Initial & Last Name & Degree

Gilles RODE, MD

Phone

(0)4 78 86 50 66

Ext

+33

gille.rode@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Gilles RODE, MD

First Name & Middle Initial & Last Name & Degree

Amandine GUINET-LACOSTE, MD

First Name & Middle Initial & Last Name & Degree

Jacques LUAUTE, MD

First Name & Middle Initial & Last Name & Degree

Sophie JACQUIN-COURTOIS, MD

First Name & Middle Initial & Last Name & Degree

Yves ROSSETTI, MD

First Name & Middle Initial & Last Name & Degree

Julie DI MARCO, MD

Facility Name

CHU Saint-Etienne

City

Saint-Étienne

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal GIRAUX, MD

Phone

04 77 12 77 57

Ext

+33

pascal.giraux@chu-st-etienne.fr

First Name & Middle Initial & Last Name & Degree

Pascal GIRAUX, MD

First Name & Middle Initial & Last Name & Degree

PAUL CALMELS, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34819284

Citation

Hugues A, Guinet-Lacoste A, Bin S, Villeneuve L, Lunven M, Perennou D, Giraux P, Foncelle A, Rossetti Y, Jacquin-Courtois S, Luaute J, Rode G. Effects of prismatic adaptation on balance and postural disorders in patients with chronic right stroke: protocol for a multicentre double-blind randomised sham-controlled trial. BMJ Open. 2021 Nov 24;11(11):e052086. doi: 10.1136/bmjopen-2021-052086.

Results Reference

derived

Learn more about this trial

Prismatic Adaptation for Rehabilitation of Postural Imbalance After Stroke

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