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Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular AccidentAVCPOSTIMNCT01677091

Balance Rehabilitation With Sensory Recalibration After Stroke

A study testing Cervical vibration, Prism adaptation and Conventional rehabilitation in people with Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident, run by Rennes University Hospital at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Cervical vibration, Prism adaptation and Conventional rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
8 sitesFrance
Study dates
5 May 2013to 14 Oct 2019
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

  • Right unilateral supratentorial ischemic or hemorrhagic lesion
  • Adult (age ≥ 18 years) under 80 years
  • Stroke
  • older than 9 months
  • with or without hemianopsia
  • with or without visuospatial hemineglect
Show all 10Show fewer
  • The first symptomatic episode
  • Standing balance ≥ 30 sec unaided
  • Percentage of weight rests on the hemiplegic lower limb below 40% of body weight (on a platform of strength)
  • Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)

Who cannot join

  • Orthopedic, rheumatologic or visual disorders affecting the distribution of the center of pressure while standing
  • Visual disorder that does not allow assessment of the longitudinal axis or visual straight ahead
  • Ischemic or hemorrhagic brain stem lesion
  • Trouble for understanding protocol procedures
  • Inclusion Criteria for the healthy volunteers (ancillary study) :
  • Age ≥ 18 years, right-handed, sex and age-matched (+/- 5 years) to the patients of the coordinating center
Show all 10Show fewer
  • Able to get an MRI
  • With no imbalance
  • With no visual disorder impacting the repartition of the center of pression when standing up, or that does not allow assessment of the longitudinal axis or visual straight ahead
  • Written informed consent

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites
  • CHU Grenoble

    Grenoble, 38701

  • CHU Lille

    Lille, 59000

  • CHU Lyon

    Lyon

  • IRF Nancy

    Nancy

  • CHU Lariboisière-Saint Louis Paris

    Paris, 75010

  • Centre de Rééducation de Kerpape

    Ploemeur, 56270

  • CHU Reims

    Reims, 51100

  • CHU Rennes-Pontchaillou

    Rennes, 35000

Other trials in France

About this study

Official title: Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.

The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.

Read the detailed description

Imbalance is particularly severe after a Cerebral Vascular Accident because they not only limit the capacity of transfer and are a source of falls but also represent an obstacle to the acquisition of autonomy.

When the brain lesion is located in the right hemisphere, the prognosis in terms of equilibrium is worse probably because of the presence of disorders of spatial cognition. These disorders of spatial cognition are manifested by a distortion of the mental representation of space and body in space that probably cause a deviation of the position of the center of pression on platform. This component of balance disorders secondary to disruption of spatial cognition, do not benefit at present from specific rehabilitative treatment despite the severity of the consequences.

But the application of sensory manipulations has proven its effectiveness on visuospatial neglect that is another disorder of spatial cognition closed to the pathophysiology of balance disorders after right brain lesion. Sensory manipulations decrease the distortion of internal representations of the body in space by restoring the symmetry of sensory inputs. Some of these manipulations (visual manipulation by wearing prisms and proprioceptive manipulations) are also effective on the immediate correction of postural imbalances on force platform and disorders of spatial perception.

We therefore believe that the approach by repeated sensory manipulation is a new promising way of research for the rehabilitative treatment of balance disorders secondary to disorders of spatial cognition. As the mechanisms of action and the structures involved during proprioceptive vibration of neck muscles and during visual prism adaptation are different, we believe that the combination of these two types of sensory manipulations will permit to obtain a greater and longer lasting effect than a lonely manipulation. The concomitant evaluation of the bias on postural platform and the perception of the body axis will allow us to assess the impact of such rehabilitation on the disorders of spatial representation and so better understand the mechanisms of action of sensory manipulations.

The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration (V) and / or prism adaptation (P) in patients with left hemiplegia on balance at the end of the intervention (day14).

Secondary objectives are to test:

  • The immediate effect (day 0) on force platform evaluation of balance,
  • Maintaining the gain at 3 months and 6 months on balance,
  • Effectiveness at day 14 on negligence
  • Maintaining the gain at 3 months and 6 months on neglect,
  • Effectiveness at day 14 on functional abilities,
  • Maintaining the gain at 3 months and 6 months on functional abilities,
  • Understanding the mechanisms of action of each of the sensory manipulations by assessing changes in perceptions of space, after rehabilitation programs (day 14) and at 3 months and 6 months.
  • To evaluate the evolution of motility, sensitivity and spasticity in the various assessments.

During the 15 days rehabilitation performed for the study, the upper and lower limbs motor rehabilitation will last less than one hour and a half, and will exclude instrumental techniques of balance rehabilitation, sensory manipulations, virtual reality, strain-induced therapy.

Moreover, an ancillary study will be performed to study the immediate neurofunctional effect of vibratory stimulation, in right brain-damaged patients with imbalance and in healthy volunteers, through the assessment of cerebral activation changes in MRI. The secondary objectives of this ancillary study are to test the neurofunctional effect of repeated vibratory stimulation in right brain-damaged patients, describe the relationship between cerebral activation changes and evolution of balance, and describe the areas of the brain activated by vibratory stimulation.

Being tested
Cervical vibration, Prism adaptation, Conventional rehabilitation
Keywords
Balance,Hemiplegia,Cervical vibration,Prism adaptation,Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical vibrationOther

    Vibration of neck muscles during 10 minutes

  • Prism adaptationOther

    Prism adaptation during 10 minutes

  • Conventional rehabilitationOther

    conventional rehabilitation

Study groups in NCT01677091
Study groupRoleWhat they receive
Control groupActive comparatorThis group will benefit from conventional rehabilitation
Receives: Other: Conventional rehabilitation
Cervical vibrationExperimentalThis group will benefit from a daily 20 minutes session, with vibration of neck muscles during 10 minutes
Receives: Other: Cervical vibration
Prism adaptationExperimentalThis group will benefit from a daily 20 minutes session, with prism adaptation during 10 minutes
Receives: Other: Prism adaptation
Cervical vibration + Prism adaptationExperimentalThis group will receive a daily 30 minutes session, with cervical vibration during 10 minutes + prism adaptation during 10 minutes
Receives: Other: Cervical vibration; Other: Prism adaptation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention.

    Measured: Day 14

Secondary outcomes (4)
  1. Evaluation of balance

    • Postural Assessment Scale for Stroke
    • Scale for Contraversive Pushing
    • Berg Balance Scale
    • Timed Up and Go
    • Measurement performed on the platform of strength:
    • surface of the center of mass displacement
    • deviation of the mean position of the center pressure on the anteroposterior axis
    • standard deviation of the average displacement of the center pressure on the mediolateral axis and the anteroposterior axis,
    • percentage of support on the hemiplegic lower limb.

    Measured: Day 0, Day 14, Month 3, Month 6

  2. Evaluation of functional capacity

    • Barthel Index (Day 0, Day 14, Month 3, Month 6)
    • Number of hours of help at home (Month 3, Month 6)
    • Total Duration of hospitalization since the Cerebral Vascular Accident (Month 3, Month 6)

    Measured: Day 0, Day 14, Month 3, Month 6

  3. Evaluation of negligence

    • Bell test,
    • Bisection test,
    • Scale of Catherine Bergego,
    • OTA test
    • Test of bodily neglect.

    Measured: Day 0, Day 14, Month 3, Month 6

  4. Understanding the mechanisms of sensory manipulations

    • Evaluation of longitudinal axis by a fluorescent bar movement in front of the patient through a computerized system.
    • Haptic Straight Ahead using a graduated table on which the subject moves his hand blindfolded.

    Measured: Day 0, Day 14, Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2012 (estimated)
  2. Study start5 May 2013
  3. Primary completion14 Oct 2019
  4. Study completion14 Oct 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01677091
Sponsor's protocol ID
2012-A00667-36
Acronym
AVCPOSTIM
Status last verified
May 2023
First submitted
29 Aug 2012
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • Leplaideur S, Moulinet-Raillon A, Duche Q, Chochina L, Jamal K, Ferre JC, Bannier E, Bonan I. The Neural Bases of Egocentric Spatial Representation for Extracorporeal and Corporeal Tasks: An fMRI Study. Brain Sci. 2021 Jul 22;11(8):963. doi: 10.3390/brainsci11080963.

    PubMed 34439582
  • Jamal K, Leplaideur S, Rousseau C, Cordillet S, Raillon AM, Butet S, Cretual A, Bonan I. The effects of repetitive neck-muscle vibration on postural disturbances after a chronic stroke. Neurophysiol Clin. 2020 Sep;50(4):269-278. doi: 10.1016/j.neucli.2020.01.005. Epub 2020 Mar 31.

    PubMed 32245547
  • Foussat E, Painchaud S, Leplaideur S, Rousseau C, Viallard L, Bonan I, Jamal K. Factors associated with Severe Balance Impairment After Right-Hemisphere Stroke: The Role of Spatial Neglect and Lateropulsion: A Secondary Analysis of Multicenter Cross-Sectional Study POSTIM. NeuroRehabilitation. 2026 Oct 29:10538135261494072. doi: 10.1177/10538135261494072. Online ahead of print.

    PubMed 42957620
  • Painchaud S, Duche Q, Allart E, Leplaideur S, Bannier E, Bonan I. Investigating the Neural Bases of Egocentric Spatial Reference Frame After Right-Hemisphere Stroke: Brain Lesions and Disconnectome Analyses of Subjective Straight Ahead and Longitudinal Body Axis Misperception. Hum Brain Mapp. 2026 Oct 1;47(14):e70637. doi: 10.1002/hbm.70637.

    PubMed 42768733
  • Jamal K, Leplaideur S, Rousseau C, Foussat E, Painchaud S, Viallard L, Bonan I. Identifying the Factors With Later Standing Acquisition in Patients With a Right-Hemisphere Stroke: A Cross-Sectional Study Using POSTIM Data. Ann Rehabil Med. 2026 Jun;50(3):160-167. doi: 10.5535/arm.250125. Epub 2026 Jun 29.

    PubMed 42392229
  • Leplaideur S, Allart E, Chochina L, Perennou D, Rode G, Boyer FC, Paysant J, Yelnik A, Jamal K, Duche Q, Morcet JF, Laviolle B, Combes B, Bannier E, Bonan I. Neck muscle vibration and prism adaptation fail to improve balance disturbances after stroke: A multicentre randomised controlled study. Ann Phys Rehabil Med. 2024 Oct;67(7):101871. doi: 10.1016/j.rehab.2024.101871. Epub 2024 Aug 21.

    PubMed 39173550

Questions about this trial

What is this clinical trial studying?

A study testing Cervical vibration, Prism adaptation and Conventional rehabilitation in people with Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident, run by Rennes University Hospital at 8 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention. (time frame: Day 14). 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 NCT01677091, which also lists 6 linked publications.

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 24 May 2023.

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