Functional Proprioceptive Stimulation of the Upper Limbs in Stroke Patients

NCT06143475 | Completed

• 1 other identifier: Vibramoov Uper Limb 01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Motor Disorders; Upper Extremity Paresis; Muscle Weakness; Vibration; Exposure

Keywords

functional proprioceptive stimulation; rehabilitation; spasticity; stroke

Outcome Measures

Primary Outcomes (2)

• Muscle strength

  Muscle strength was assessed using the MRC (Medical Research Council Weakness Scale). MRC is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). Paresis is defined as light at compliance with strength 4 points, moderate - 3 points, pronounced - 2 points, rough - 1 point and with - 0 points.

  Change from baseline at 3 weeks

• Muscle tone

  To assess muscle tone the MAS - Modified Ashworth Scale was used. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.

  Change from baseline at 3 weeks

Secondary Outcomes (4)

• Fugl-Meyer Assessment Scale for upper extremity assessment

  Change from baseline at 3 weeks

• Frenchay Arm Test

  Change from baseline at 3 weeks

• The Action Research Arm Test (ARAT)

  Change from baseline at 3 weeks

• The Numeric Pain Rating Scale (NPRS)

  Change from baseline at 3 weeks

Study Arms (2)

FPS group

EXPERIMENTAL

In the FPS group, in addition to same physical therapy ran in the control group, the patient received FPS from the apparatus "Vibramoov" (Techno Concept, France) on their upper limbs. The patients received in total 12 Vibramoov sessions of 30 minutes, 5 times a week.

Device: FPS group

Conventional therapy group

ACTIVE COMPARATOR

In the conventional therapy group patients received sessions of traditional physical therapy: individual therapy sessions including exercises to strengthen muscles, stretching, reflex exercises for large, medium and small muscle groups of the upper limbs (ontogeny-oriented kinesiotherapy (OOKT), PNF - proprioceptive neuro-muscle facilitation, training and practice of functional rational self-service tasks). 12 sessions in total were realized 5 times a week and lasted 40 minutes each.

Other: Conventional therapy group

Interventions

FPS group DEVICE

Vibration frequency ranged from 0 to 100 Hz. There were 3 modes of FPS application during rehabilitation course. 1) anti-spasticity mode (FV): the stimulators were placed in the middle of the muscles of the affected limb (i.e. unilaterally); 2) bilateral mode of proprioceptive facilitation; and 3) the unilateral mode of the proprioceptive facilitation. The 2 first sessions were realized with bilateral FPS stimulations plus the anti-spasticity FV mode to reduce the level of hypertonia. Then for 6 consecutive sessions unilateral FPS stimulations of the affected sides imitating the drawing of a straight lines (horizontal, vertical, diagonal), preparing for writing (drawing a circle, triangle, square, spiral) were realized. At last, the 4 remaining FPS sessions were realized unilaterally imitating and promoting the realization of everyday life activities.

FPS group

Conventional therapy group OTHER

Patients received sessions of traditional physical therapy: individual therapy sessions including exercises to strengthen muscles, stretching, reflex exercises for large, medium and small muscle groups of the upper limbs (ontogeny-oriented kinesiotherapy (OOKT), PNF - proprioceptive neuro-muscle facilitation, training and practice of functional rational self-service tasks). 12 sessions in total were realized 5 times a week and lasted 40 minutes each.

Conventional therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health: lead

Study Sites (1)

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Stroke; Motor Disorders; Paresis; Muscle Weakness; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathologic Processes; Muscle Hypertonia

Study Officials

• Galina Ivanova, Prof

  Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Clinicians involved in the measurements and researchers that worked with data results did not know which group each patient was in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group, single-blinded controlled clinical trial

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: February 20, 2021
• Primary Completion: April 5, 2023
• Study Completion: October 29, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)