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

Civil Hospices of Lyon

Status: Unknown

Conditions: Chronic Right Supratensorial Stroke Patients

Treatments: Device: The prismatic adaptation (PA); Device: The sham prismatic adaptation (S-PA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03154138

69HCL17_0172

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

28 participants in 2 patient groups, including a placebo group

Prismatic adaptation (PA) group

Experimental group

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.

Treatment:

Device: The prismatic adaptation (PA)

Sham group

Placebo Comparator group

Description:

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.

Treatment:

Device: The sham prismatic adaptation (S-PA)