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Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients (BAT)

Primary Purpose

Stroke, Hemiparesis

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Proprioceptive based training (PBT)
Conventional neuromotor treatment (CNT).
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Neurorehabilitation, Proprioceptive Training, Bilateral Arm Training, Intracortical Inhibition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Fondazione Ospedale San Camillo IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Proprioceptive based training (PBT)

Conventional neuromotor treatment (CNT)

Arm Description

The treatment will last one hour and will be divided as follows: 2 proprioceptive based stimulation sessions per 3 minutes for each movement, with a rest of 2 minutes between each session. Every patient will receive 15 treatments, 5 days a week, for 3 weeks.

The CNT group will be treated for one hour daily by means of a CNT programme. The treatment will last 3 weeks.

Outcomes

Primary Outcome Measures

Medical Research Council scale (MRC)
Applied at the beginning and at the end of treatment (after 15 sessions). The following muscles will be considered: deltoid, biceps brachii, triceps brachii, flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, flexor digitorum and extensor digitorum.
Dynamometer
Applied at the beginning and at the end of treatment (after 15 sessions)

Secondary Outcome Measures

Fugl-Meyer Upper Extremity scale (FM UE)
Applied at the beginning and at the end of treatment (after 15 sessions).
Functional Independence Measure scale (FIM)
Applied at the beginning and at the end of treatment (after 15 sessions)
Modified Ashworth Scale
Applied at the beginning and at the end of treatment (after 15 sessions).
surface Electromyography (sEMG)
Applied at the beginning and at the end of treatment (after 15 sessions) and aiming to record the maximal voluntary contraction (MVC). sEMG signal will be recorded online during the tasks in each modality with bipolar electrodes from the following muscles; long head of biceps brachii, short head of biceps brachii, long head of triceps brachii and lateral head of triceps brachii.

Full Information

First Posted
May 15, 2017
Last Updated
November 3, 2021
Sponsor
IRCCS San Camillo, Venezia, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03155399
Brief Title
Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients
Acronym
BAT
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
PI transferred to another Institution
Study Start Date
July 2013 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Stroke, Neurorehabilitation, Proprioceptive Training, Bilateral Arm Training, Intracortical Inhibition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessment was conducted by two physiotherapists not involved in providing the experimental treatment.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proprioceptive based training (PBT)
Arm Type
Experimental
Arm Description
The treatment will last one hour and will be divided as follows: 2 proprioceptive based stimulation sessions per 3 minutes for each movement, with a rest of 2 minutes between each session. Every patient will receive 15 treatments, 5 days a week, for 3 weeks.
Arm Title
Conventional neuromotor treatment (CNT)
Arm Type
Other
Arm Description
The CNT group will be treated for one hour daily by means of a CNT programme. The treatment will last 3 weeks.
Intervention Type
Other
Intervention Name(s)
Proprioceptive based training (PBT)
Intervention Description
During the PBT patient will stay in supine position with the upper limbs positioned in symmetric posture. He/She will be asked to move both limbs with the same frequency performing bilateral flexion-extension of one of the upper limb districts according to the available free ROM of the target joint. The movement execution of the affected arm will be supported by the physiotherapist performing passive movement at the same rhythm, as the one executed with the unaffected side. Patient will be asked to focus the attention on the movement performed against gravity, which will be reinforced by a verbal command. Afterwards, the physiotherapist will fully support movement execution coherently with the patient's movement initialization. The active movement performed voluntarily by the patient with unaffected limb will be considered as the reference movement, that the physiotherapist has to emulate passively, by synchronization of passive movement executed in phase with the affected side.
Intervention Type
Other
Intervention Name(s)
Conventional neuromotor treatment (CNT).
Intervention Description
The patients randomized to the CNT group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity.
Primary Outcome Measure Information:
Title
Medical Research Council scale (MRC)
Description
Applied at the beginning and at the end of treatment (after 15 sessions). The following muscles will be considered: deltoid, biceps brachii, triceps brachii, flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, flexor digitorum and extensor digitorum.
Time Frame
Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)
Title
Dynamometer
Description
Applied at the beginning and at the end of treatment (after 15 sessions)
Time Frame
Change from baseline of dynamometer at the end of PBT (three weeks thereafter)
Secondary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity scale (FM UE)
Description
Applied at the beginning and at the end of treatment (after 15 sessions).
Time Frame
Change from baseline of the FM UE scale at the end of PBT (three weeks thereafter)
Title
Functional Independence Measure scale (FIM)
Description
Applied at the beginning and at the end of treatment (after 15 sessions)
Time Frame
Change from baseline of the FIM scale at the end of PBT (three weeks thereafter)
Title
Modified Ashworth Scale
Description
Applied at the beginning and at the end of treatment (after 15 sessions).
Time Frame
Change from baseline of the Ashworth scale at the end of PBT (three weeks thereafter)
Title
surface Electromyography (sEMG)
Description
Applied at the beginning and at the end of treatment (after 15 sessions) and aiming to record the maximal voluntary contraction (MVC). sEMG signal will be recorded online during the tasks in each modality with bipolar electrodes from the following muscles; long head of biceps brachii, short head of biceps brachii, long head of triceps brachii and lateral head of triceps brachii.
Time Frame
Change from baseline of the MVC at the end of PBT (three weeks thereafter)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: time since stroke up to 6 months, presence of the upper limb plegia (0 point according to the Medical Research Council scale), passive range of motion (ROM) completely free, absence of primary joint trauma of the wrist, elbow and shoulder, Exclusion Criteria: increased muscle tone (score higher than 1 point in modified Ashworth scale), apraxia (De Renzi test < 62 points), global sensory aphasia (clinical notes), neglect (clinical notes), cognitive impairments (Mini Mental State Examination test < 24 points) , severe sensitivity disorders ( < 1 point in items shoulder, elbow, wrist and thumb at the proprioceptive sensitivity section of the Fugl-Meyer scale), stroke lesion located in the cerebellum (clinical notes).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawel Kiper, PhD
Organizational Affiliation
Fondazione Ospedale San Camillo IRCCS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, PhD
Organizational Affiliation
Fondazione Ospedale San Camillo IRCCS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michela Agostini, MSc
Organizational Affiliation
Fondazione Ospedale San Camillo IRCCS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alfonc Baba, MSc
Organizational Affiliation
Fondazione Ospedale San Camillo IRCCS
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione Ospedale San Camillo IRCCS
City
Venezia
ZIP/Postal Code
30126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27653881
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.
Results Reference
background
PubMed Identifier
29340175
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.
Results Reference
result

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Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients

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