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

IRCCS San Camillo, Venezia, Italy

Status: Terminated

Conditions: Stroke; Hemiparesis

Treatments: Other: Proprioceptive based training (PBT); Other: Conventional neuromotor treatment (CNT).

Study type: Interventional

Funder types: Other

Identifiers

NCT03155399

Protocollo 2012.07 BAT v.1.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Proprioceptive based training (PBT)

Experimental group

Description:

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.

Treatment:

Other: Proprioceptive based training (PBT)

Conventional neuromotor treatment (CNT)

Other group

Description:

The CNT group will be treated for one hour daily by means of a CNT programme. The treatment will last 3 weeks.

Treatment:

Other: Conventional neuromotor treatment (CNT).