Clinical trial NCT03154138: Prismatic Adaptation for Rehabilitation of Postural Imbalance After Stroke
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Right Supratensorial Stroke Patients
Keywords: Stroke
hemiplegia
rehabilitation
prismatic adaptation
postural imbalance
posture
spatial cognition
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Université Claude Bernard Lyon 1 (UCBL)
name: Equipe " ImpAct Trajectoires " du Centre de Recherche en Neurosciences de Lyon (CRNL)
First posted: 2017-05-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS)
timeFrame: Change from baseline (mean of the 2 pre-tests) at 7 days after the end of treatment (3 weeks about after the baseline)
Secondary outcomes:
measure: Balance: the inter-group difference of within-group changes for the Berg Balance Scale (BBS)
timeFrame: Change from baseline at 1 month after the end of treatment
measure: Balance: The inter-group difference of within-group changes for standing static posturographic variables
timeFrame: Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment
measure: Lateropulsion: The inter-group difference of within-group changes for the Scale for Contraversive Pushing (SCP)
timeFrame: Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment.
measure: The inter-group difference of within-group changes for each spatial reference frame (MSSA, VSSA, OLP, LBA)
timeFrame: Change from baseline at +2 Hours, Day 3, Day 7, Month 1 and Month 3 after the end of treatment
measure: Autonomy : Inter-group difference of within-group changes for the Barthel index (BI)
timeFrame: Change from baseline (pre-test) at Day7, Month +1 and Month +3 after the end of treatment.
measure: Additionnal descriptive anatomic study of cerebral lesions using diffusion tensor Magnetic Resonance Imaginig (MRI) (Tractography)
timeFrame: Before the starting of the intervention, during the pre-tests.
measure: Relationship between prismatic adaptation induced changes on misperceptions of spatial reference frames and these on postural and balance disorders
timeFrame: +2Hours, Day+3, Day+7, Month+1 and Month+3.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
city: Saint-Genis-Laval
country: France
facility: Hôpital Henry Gabrielle, service de médecine physique et réadaptation
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Amandine GUINET-LACOSTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.