Chronic Right Supratensorial Stroke PatientsPEQUIENCT03154138
Prismatic Adaptation for Rehabilitation of Postural Imbalance After Stroke
A study testing The prismatic adaptation (PA) in people with Chronic Right Supratensorial Stroke Patients, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Right Supratensorial Stroke Patients
- What is being tested?
- The prismatic adaptation (PA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Dec 2017to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, over 18 years old, and less than 80 years old
- Stroke
- right
- supratensorial,
- unilateral,
- haemorrhagic or ischemic,
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
CHU Grenoble
Grenoble
DOMINIC PERENNOU, MD, 04 76 76 60 85 ext. +33, dperennou@chu-grenoble.fr
DOMINIC PERENNOU, MD
- Not yet recruiting
CHU Saint-Etienne
Saint-Etienne
Pascal GIRAUX, MD, 04 77 12 77 57 ext. +33, pascal.giraux@chu-st-etienne.fr
Pascal GIRAUX, MD
- Recruiting
Hôpital Henry Gabrielle, service de médecine physique et réadaptation
Saint-Genis-Laval, 69230
Aurélien HUGUES, PhD, (0)6 37 05 40 40 ext. +33, huguesaurelien@gmail.com
Gilles RODE, MD, (0)4 78 86 50 66 ext. +33, gille.rode@chu-lyon.fr
About this study
Official title: Assessment of the Rehabilitation of Postural Imbalance After Chronic Right Supratensorial Stroke by Prismatic Adaptation: Multicentric Randomised Sham-controlled Trial
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.
Read more
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.
- Being tested
- The prismatic adaptation (PA), The sham prismatic adaptation (S-PA)
- Keywords
- Stroke, hemiplegia, rehabilitation, prismatic adaptation, postural imbalance, posture, spatial cognition
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The prismatic adaptation (PA)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)
The sham prismatic adaptation (S-PA)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)
| Study group | Role | What they receive |
|---|---|---|
| Prismatic adaptation (PA) group | Experimental | 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. Receives: Device: The prismatic adaptation (PA) |
| Sham group | Placebo comparator | 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. Receives: Device: The sham prismatic adaptation (S-PA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (7)
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.
Measured: Change from baseline at 1 month after the end of treatment
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.
Measured: Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment
Lateropulsion: The inter-group difference of within-group changes for the Scale for Contraversive Pushing (SCP)
Score between 0 and 6 points
Measured: Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment.
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
Measured: Change from baseline at +2 Hours, Day 3, Day 7, Month 1 and Month 3 after the end of treatment
Autonomy : Inter-group difference of within-group changes for the Barthel index (BI)
Score between 0 and 100 points
Measured: Change from baseline (pre-test) at Day7, Month +1 and Month +3 after the end of treatment.
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).
Measured: Before the starting of the intervention, during the pre-tests.
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.
Measured: +2Hours, Day+3, Day+7, Month+1 and Month+3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start4 Dec 2017
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Right Supratensorial Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France, Claude Bernard University, Equipe " ImpAct Trajectoires " du Centre de Recherche en Neurosciences de Lyon (CRNL)
- Responsible party
- Sponsor
- Investigators
- Amandine GUINET-LACOSTE, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154138
- Sponsor's protocol ID
- 69HCL17_0172
- Acronym
- PEQUIE
- Status last verified
- Mar 2022
- First submitted
- 12 May 2017
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34819284
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Rehabilitation of Postural Imbalance After Chronic Right Supratensorial Stroke by Prismatic Adaptation: Multicentric Randomised Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT03154138
- Acronym / sponsor ID
- PEQUIE / 69HCL17_0172
- Keywords
- Stroke, hemiplegia, rehabilitation, prismatic adaptation, postural imbalance, posture, spatial cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France, Claude Bernard University, Equipe " ImpAct Trajectoires " du Centre de Recherche en Neurosciences de Lyon (CRNL)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prismatic adaptation (PA) group | Experimental | Device: The prismatic adaptation (PA)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. |
| Sham group | Placebo comparator | Device: The sham prismatic adaptation (S-PA)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult, over 18 years old, and less than 80 years old
- Stroke
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Prismatic adaptation (PA) group |
| 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) | Device | Sham group |
Primary outcome
Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS)
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)
Balance : The inter-group difference of within-group changes for the Berg Balance Scale (BBS) Score between 0 and 56 points
7 secondary outcomes
Balance: the inter-group difference of within-group changes for the Berg Balance Scale (BBS)
Time frame: Change from baseline at 1 month after the end of treatment
Balance: The inter-group difference of within-group changes for standing static posturographic variables
Time frame: Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment
Lateropulsion: The inter-group difference of within-group changes for the Scale for Contraversive Pushing (SCP)
Time frame: Change from baseline at +2 Hours, Day 3, Day7, Month +1 and Month +3 after the end of treatment.
The inter-group difference of within-group changes for each spatial reference frame (MSSA, VSSA, OLP, LBA)
Time frame: Change from baseline at +2 Hours, Day 3, Day 7, Month 1 and Month 3 after the end of treatment
Autonomy : Inter-group difference of within-group changes for the Barthel index (BI)
Time frame: Change from baseline (pre-test) at Day7, Month +1 and Month +3 after the end of treatment.
Additionnal descriptive anatomic study of cerebral lesions using diffusion tensor Magnetic Resonance Imaginig (MRI) (Tractography)
Time frame: Before the starting of the intervention, during the pre-tests.
Relationship between prismatic adaptation induced changes on misperceptions of spatial reference frames and these on postural and balance disorders
Time frame: +2Hours, Day+3, Day+7, Month+1 and Month+3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 34819284Hugues 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine GUINET-LACOSTE, MD principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The prismatic adaptation (PA) in people with Chronic Right Supratensorial Stroke Patients, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélien HUGUES, PhD (0637054040 ext. +33, huguesaurelien@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03154138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.