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

November 3, 2021 updated by: Pawel Kiper, IRCCS San Camillo, Venezia, Italy

Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients (Stimolazione Propriocettiva Manuale Con Esercizio Ritmico Bilaterale in Pazienti Post Ictus - BAT)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Venezia, Italy, 30126
        • Fondazione Ospedale San Camillo IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proprioceptive based training (PBT)
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.
Other: Proprioceptive based training (PBT)
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.
Other: Conventional neuromotor treatment (CNT)
The CNT group will be treated for one hour daily by means of a CNT programme. The treatment will last 3 weeks.
Other: Conventional neuromotor treatment (CNT).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Research Council scale (MRC)
Time Frame: Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)
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.
Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)
Dynamometer
Time Frame: Change from baseline of dynamometer at the end of PBT (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions)
Change from baseline of dynamometer at the end of PBT (three weeks thereafter)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity scale (FM UE)
Time Frame: Change from baseline of the FM UE scale at the end of PBT (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions).
Change from baseline of the FM UE scale at the end of PBT (three weeks thereafter)
Functional Independence Measure scale (FIM)
Time Frame: Change from baseline of the FIM scale at the end of PBT (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions)
Change from baseline of the FIM scale at the end of PBT (three weeks thereafter)
Modified Ashworth Scale
Time Frame: Change from baseline of the Ashworth scale at the end of PBT (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions).
Change from baseline of the Ashworth scale at the end of PBT (three weeks thereafter)
surface Electromyography (sEMG)
Time Frame: Change from baseline of the MVC at the end of PBT (three weeks thereafter)
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.
Change from baseline of the MVC at the end of PBT (three weeks thereafter)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Camillo, Venezia, Italy

Investigators

  • Principal Investigator: Pawel Kiper, PhD, Fondazione Ospedale San Camillo IRCCS
  • Study Director: Andrea Turolla, PhD, Fondazione Ospedale San Camillo IRCCS
  • Study Chair: Michela Agostini, MSc, Fondazione Ospedale San Camillo IRCCS
  • Study Chair: Alfonc Baba, MSc, Fondazione Ospedale San Camillo IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocollo 2012.07 BAT v.1.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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