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

NCT03155399 | Terminated DMC

• 1 other identifier: Protocollo 2012.07 BAT v.1.2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

Stroke; Neurorehabilitation; Proprioceptive Training; Bilateral Arm Training; Intracortical Inhibition

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)

• Dynamometer

  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 Outcomes (4)

• Fugl-Meyer Upper Extremity scale (FM UE)

  Change from baseline of the FM UE scale at the end of PBT (three weeks thereafter)

• Functional Independence Measure scale (FIM)

  Change from baseline of the FIM scale at the end of PBT (three weeks thereafter)

• Modified Ashworth Scale

  Change from baseline of the Ashworth scale at the end of PBT (three weeks thereafter)

• surface Electromyography (sEMG)

  Change from baseline of the MVC at the end of PBT (three weeks thereafter)

Study Arms (2)

Proprioceptive based training (PBT)

EXPERIMENTAL

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)

Conventional neuromotor treatment (CNT)

OTHER

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).

Interventions

Proprioceptive based training (PBT) OTHER

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.

Proprioceptive based training (PBT)

Conventional neuromotor treatment (CNT). OTHER

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.

Conventional neuromotor treatment (CNT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

Fondazione Ospedale San Camillo IRCCS

Venezia, 30126, Italy

Location

Related Publications (2)

• 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.

  PMID: 27653881 BACKGROUND

• 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.

  PMID: 29340175 RESULT

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pawel Kiper, PhD

  Fondazione Ospedale San Camillo IRCCS

  PRINCIPAL INVESTIGATOR

• Andrea Turolla, PhD

  Fondazione Ospedale San Camillo IRCCS

  STUDY DIRECTOR

• Michela Agostini, MSc

  Fondazione Ospedale San Camillo IRCCS

  STUDY CHAIR

• Alfonc Baba, MSc

  Fondazione Ospedale San Camillo IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment was conducted by two physiotherapists not involved in providing the experimental treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: July 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)