Balance Rehabilitation With Sensory Recalibration After Stroke
AVCPOSTIM
Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.
1 other identifier
interventional
114
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2012
CompletedFirst Posted
Study publicly available on registry
August 31, 2012
CompletedStudy Start
First participant enrolled
May 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2019
CompletedMay 24, 2023
May 1, 2023
6.4 years
August 29, 2012
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Day 14
Secondary Outcomes (4)
Evaluation of balance
Day 0, Day 14, Month 3, Month 6
Evaluation of functional capacity
Day 0, Day 14, Month 3, Month 6
Evaluation of negligence
Day 0, Day 14, Month 3, Month 6
Understanding the mechanisms of sensory manipulations
Day 0, Day 14, Month 3, Month 6
Other Outcomes (4)
Time since stroke
day 0
Extent of the injury and localization of brain injury
>2 months after hemiplegia
Severity of hemiplegia
day 0
- +1 more other outcomes
Study Arms (4)
Control group
ACTIVE COMPARATORThis group will benefit from conventional rehabilitation
Cervical vibration
EXPERIMENTALThis group will benefit from a daily 20 minutes session, with vibration of neck muscles during 10 minutes
Prism adaptation
EXPERIMENTALThis group will benefit from a daily 20 minutes session, with prism adaptation during 10 minutes
Cervical vibration + Prism adaptation
EXPERIMENTALThis group will receive a daily 30 minutes session, with cervical vibration during 10 minutes + prism adaptation during 10 minutes
Interventions
Vibration of neck muscles during 10 minutes
Prism adaptation during 10 minutes
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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
- Age ≥ 18 years, right-handed, sex and age-matched (+/- 5 years) to the patients of the coordinating center
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CHU Grenoble
Grenoble, 38701, France
CHU Lille
Lille, 59000, France
CHU Lyon
Lyon, France
IRF Nancy
Nancy, France
CHU Lariboisière-Saint Louis Paris
Paris, 75010, France
Centre de Rééducation de Kerpape
Ploemeur, 56270, France
CHU Reims
Reims, 51100, France
CHU Rennes-Pontchaillou
Rennes, 35000, France
Related Publications (3)
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.
PMID: 34439582RESULTJamal 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.
PMID: 32245547RESULTLeplaideur 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.
PMID: 39173550DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle BONAN, PU PH
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2012
First Posted
August 31, 2012
Study Start
May 5, 2013
Primary Completion
October 14, 2019
Study Completion
October 14, 2019
Last Updated
May 24, 2023
Record last verified: 2023-05