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

Stroke Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03155399
• Other study ID #: Protocollo 2012.07 BAT v.1.2
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2018

Study information

• Verified date: November 2021
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Ospedale San Camillo IRCCS	Venezia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. eColl — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Fugl-Meyer Upper Extremity scale (FM UE)	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)
Secondary	Functional Independence Measure scale (FIM)	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)
Secondary	Modified Ashworth Scale	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)
Secondary	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.	Change from baseline of the MVC at the end of PBT (three weeks thereafter)