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

NCT ID: NCT03155399

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-12-31

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.

Conditions

Stroke; Hemiparesis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Proprioceptive based training (PBT)

Intervention Type: 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.

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.

Group Type: OTHER

Conventional neuromotor treatment (CNT).

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role: lead

Responsible Party

Pawel Kiper

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pawel Kiper, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Ospedale San Camillo IRCCS

Andrea Turolla, PhD

Role: STUDY_DIRECTOR

Fondazione Ospedale San Camillo IRCCS

Michela Agostini, MSc

Role: STUDY_CHAIR

Fondazione Ospedale San Camillo IRCCS

Alfonc Baba, MSc

Role: STUDY_CHAIR

Fondazione Ospedale San Camillo IRCCS

Locations

Fondazione Ospedale San Camillo IRCCS

Venezia, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 27653881 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29340175 (View on PubMed)

Other Identifiers

Protocollo 2012.07 BAT v.1.2

Identifier Type: -

Identifier Source: org_study_id