Prismatic Adaptation for Rehabilitation of Postural Imbalance After Stroke

NCT ID: NCT03154138

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2024-04-30

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.

Conditions

Chronic Right Supratensorial Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Prismatic adaptation (PA) group

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.

Group Type: EXPERIMENTAL

The prismatic adaptation (PA)

Intervention Type: DEVICE

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)

Sham group

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.

Group Type: PLACEBO_COMPARATOR

The sham prismatic adaptation (S-PA)

Intervention Type: DEVICE

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)

Interventions

The prismatic adaptation (PA)

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

The sham prismatic adaptation (S-PA)

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Université Claude Bernard Lyon 1 (UCBL)

UNKNOWN

Sponsor Role: collaborator

Equipe " ImpAct Trajectoires " du Centre de Recherche en Neurosciences de Lyon (CRNL)

UNKNOWN

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amandine GUINET-LACOSTE, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

CHU Grenoble

Grenoble, , France

Site Status: NOT_YET_RECRUITING

CHU Saint-Etienne

Saint-Etienne, , France

Site Status: NOT_YET_RECRUITING

Hôpital Henry Gabrielle, service de médecine physique et réadaptation

Saint-Genis-Laval, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Aurélien HUGUES, PhD

Role: CONTACT

huguesaurelien@gmail.com

0637054040 ext. +33

RODE RODE, MD

Role: CONTACT

gilles.rode@chu-lyon.fr

0478865066 ext. +33

Facility Contacts

DOMINIC PERENNOU, MD

Role: primary

dperennou@chu-grenoble.fr

04 76 76 60 85 ext. +33

Pascal GIRAUX, MD

Role: primary

pascal.giraux@chu-st-etienne.fr

04 77 12 77 57 ext. +33

Aurélien HUGUES, PhD

Role: primary

huguesaurelien@gmail.com

(0)6 37 05 40 40 ext. +33

Gilles RODE, MD

Role: backup

gille.rode@chu-lyon.fr

(0)4 78 86 50 66 ext. +33

References

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.

Reference Type: DERIVED

PMID: 34819284 (View on PubMed)

Other Identifiers

69HCL17_0172

Identifier Type: -

Identifier Source: org_study_id