Clinical trial NCT06143475: Functional Proprioceptive Stimulation of the Upper Limbs in Stroke Patients
Official title: Repetetive Sessions of Functional Proprioceptive Stimulation of the Upper Limbs in Stroke Patients During Short Rehabilitation Programm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Motor Disorders
Upper Extremity Paresis
Muscle Weakness
Vibration; Exposure
Keywords: functional proprioceptive stimulation
rehabilitation
spasticity
stroke
Lead sponsor: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group, single-blinded controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Parallel-group, single-blinded controlled clinical trial. The study involved stroke patients (no more than 3 points on a scale Rankin) dived of the control group and experimental group. Control group received daily sessions of conventional physical therapy. In addition to the same conventional physical therapy treatment, the participants of the experimental group underwent repetitive upper limb Functional Proprioceptive Stimulations (FPS) sessions.

Detailed description: Motor impairments are one of the main disabilities for stroke survivors. It includes a variety of symptoms: muscle weakness, reduce motor control, proprioception and touch, lack of endurance, spastic paresis, pathological synergies and clonuses. These impairments deeply limit their participation in everyday life activities and reduce the likelihood of a return to independence and professional activities. Restoring, maintaining or even enhancing effective sensorimotor interactions are essential for motor recovery. To do so, the use of Functional Proprioceptive Stimulation (FPS) could be a very good option. These FPS are focal vibrations applied to the musculotendinous junction. It activates the muscle spindles, i.e. stretch receptors that signal the length and changes in length of muscles. FPS then produce sensation of muscle lengthening and cause perception of movement. These FPS can also initiate the movement felt. FPS transmit information to the brain in a way that is similar to the information exchange process that occurs normally during movement, even the patient is not moving at all. In doing so, the FPS are able to maintain the patient's sensorimotor interactions, activate similar patterns of cerebral activation to those evoked by real movement. Synchronized multiple localized vibration pattern can induce the perception of complex movements like gait or drawing movements, representing a safe and effective option for rehabilitation purpose. It has been demonstrated for stroke patient that, combine with physical therapy, focal vibration could improve the stability of the proximal arm, increase motor function of the upper limb, or increase the quality of selective motor control.

In the current study, the objective was to assess the efficacy of repetitive sessions of FPS in facilitating upper limb function recovery among stroke patients with a Modified Rankin scale score of 3, over a three-week rehabilitation period.

Stroke patients participated in the study in Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health in Moscow, Russia. The study was approved by a local ethic committee and followed principles of the Declaration of Helsinki.

Parallel-group, single-blinded controlled clinical trial. The study involved stroke patients (no more than 3 points on a scale Rankin) dived of the control group and experimental group. Control group received 12 daily sessions (30 minutes, 5 times a week) of conventional physical therapy. In addition to the same conventional physical therapy treatment, the participants of the experimental group underwent repetitive upper limb FPS sessions (apparatus "Vibramoov" (Techno Concept, France)). The patients received in total 12 Vibramoov sessions of 30 minutes, 5 times a week. Before and after the course of rehabilitation procedures, the condition of the upper extremities was assessed in patients of both groups (muscle tone, muscle strength, clinical scales).

Eligibility criteria: Inclusion Criteria:

* early recovery period after newly diagnosed cerebral stroke (from 2 weeks to six months post event)
* hospital stay 18-21 days
* 3 points on the Modified Rankin Scale
* muscle tone more than 1 point on the Ashworth scale
* informed consent signed

Exclusion Criteria:

* presence in the rehabilitation program of other robotic methods
* violation of skin integument
* floating thrombosis
* pronounced cognitive deficit
* epilepsy
* refusal to participate in the study

Primary outcomes:
measure: Muscle strength
timeFrame: Change from baseline at 3 weeks
measure: Muscle tone
timeFrame: Change from baseline at 3 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment Scale for upper extremity assessment
timeFrame: Change from baseline at 3 weeks
measure: Frenchay Arm Test
timeFrame: Change from baseline at 3 weeks
measure: The Action Research Arm Test (ARAT)
timeFrame: Change from baseline at 3 weeks
measure: The Numeric Pain Rating Scale (NPRS)
timeFrame: Change from baseline at 3 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Study officials:
affiliation: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
name: Galina Ivanova, Prof
role: STUDY_CHAIR
References: