Clinical trial NCT03155399: Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients
Official title: Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients (Stimolazione Propriocettiva Manuale Con Esercizio Ritmico Bilaterale in Pazienti Post Ictus - BAT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Stroke
Neurorehabilitation
Proprioceptive Training
Bilateral Arm Training
Intracortical Inhibition
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of the repetitive proprioceptive bilateral stimulation for the early recovery of the voluntary muscle contraction in stroke patients.

Detailed description: The central nervous system (CNS) has plastic properties allowing its adaptation through development. These properties are still maintained in the adult age and potentially activated in case of brain lesion. In the present study authors hypothesized that a significant recovery of voluntary muscle contraction in post stroke patients experiencing severe upper limb paresis can be obtained, when proprioceptive based stimulations are provided. The proprioceptive based training (PBT) aims to stimulate the emergence of voluntary contraction and to foster motor recovery. It is based on motor learning principles, such as the repetition of tasks with concurrent use of feedbacks. The proposed concept is based on the concurrent repetitions of movements performed with the non-affected limb and with the affected one, passively mobilized by physiotherapist in charge of guaranteeing the optimal kinematic execution.

Eligibility criteria: Inclusion Criteria:

1. time since stroke up to 6 months,
2. presence of the upper limb plegia (0 point according to the Medical Research Council scale),
3. passive range of motion (ROM) completely free,
4. absence of primary joint trauma of the wrist, elbow and shoulder,

Exclusion Criteria:

1. increased muscle tone (score higher than 1 point in modified Ashworth scale),
2. apraxia (De Renzi test \< 62 points),
3. global sensory aphasia (clinical notes),
4. neglect (clinical notes),
5. cognitive impairments (Mini Mental State Examination test \< 24 points) ,
6. severe sensitivity disorders ( \< 1 point in items shoulder, elbow, wrist and thumb at the proprioceptive sensitivity section of the Fugl-Meyer scale),
7. stroke lesion located in the cerebellum (clinical notes).

Primary outcomes:
measure: Medical Research Council scale (MRC)
timeFrame: Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)
measure: Dynamometer
timeFrame: Change from baseline of dynamometer at the end of PBT (three weeks thereafter)
Secondary outcomes:
measure: Fugl-Meyer Upper Extremity scale (FM UE)
timeFrame: Change from baseline of the FM UE scale at the end of PBT (three weeks thereafter)
measure: Functional Independence Measure scale (FIM)
timeFrame: Change from baseline of the FIM scale at the end of PBT (three weeks thereafter)
measure: Modified Ashworth Scale
timeFrame: Change from baseline of the Ashworth scale at the end of PBT (three weeks thereafter)
measure: surface Electromyography (sEMG)
timeFrame: Change from baseline of the MVC at the end of PBT (three weeks thereafter)
Other outcomes:
Locations:
city: Venezia
country: Italy
facility: Fondazione Ospedale San Camillo IRCCS
Study officials:
affiliation: Fondazione Ospedale San Camillo IRCCS
name: Pawel Kiper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Ospedale San Camillo IRCCS
name: Andrea Turolla, PhD
role: STUDY_DIRECTOR
affiliation: Fondazione Ospedale San Camillo IRCCS
name: Michela Agostini, MSc
role: STUDY_CHAIR
affiliation: Fondazione Ospedale San Camillo IRCCS
name: Alfonc Baba, MSc
role: STUDY_CHAIR
References:
citation: Kiper P, Szczudlik A, Venneri A, Stozek J, Luque-Moreno C, Opara J, Baba A, Agostini M, Turolla A. Computational models and motor learning paradigms: Could they provide insights for neuroplasticity after stroke? An overview. J Neurol Sci. 2016 Oct 15;369:141-148. doi: 10.1016/j.jns.2016.08.019. Epub 2016 Aug 11.
citation: Kiper P, Baba A, Agostini M, Turolla A. Proprioceptive Based Training for stroke recovery. Proposal of new treatment modality for rehabilitation of upper limb in neurological diseases. Arch Physiother. 2015 Aug 3;5:6. doi: 10.1186/s40945-015-0007-8. eCollection 2015.