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

Sponsor

IRCCS San Camillo, Venezia, Italy (Other)

Overall Status

Terminated

CT.gov ID

NCT03155399

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiparesis	Other: Proprioceptive based training (PBT) Other: Conventional neuromotor treatment (CNT).	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The assessment was conducted by two physiotherapists not involved in providing the experimental treatment.

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Medical Research Council scale (MRC) [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.
Dynamometer [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)

Secondary Outcome Measures

Fugl-Meyer Upper Extremity scale (FM UE) [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).
Functional Independence Measure scale (FIM) [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)
Modified Ashworth Scale [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).
surface Electromyography (sEMG) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).