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

Not Applicable

Terminated

• Conditions: Stroke; Hemiparesis
• Interventions: Other: Conventional neuromotor treatment (CNT).; Other: Proprioceptive based training (PBT)

• Registration Number: NCT03155399
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Primary Completion: 2018-09
• Study Completion: 2018-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional neuromotor treatment (CNT)	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.
Proprioceptive based training (PBT)	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.

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

Name	Time	Method
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).
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)
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.

Trial Locations

Locations (1)

Fondazione Ospedale San Camillo IRCCS; 🇮🇹 Venezia, Italy