StrokeNCT06143475
Functional Proprioceptive Stimulation of the Upper Limbs in Stroke Patients
A study testing FPS group and Conventional therapy group in people with Stroke and Motor Disorders, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Motor Disorders, Upper Extremity Paresis
- What is being tested?
- FPS group and Conventional therapy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 20 Feb 2021to 29 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Moscow, 117997
About this study
Official title: Repetetive Sessions of Functional Proprioceptive Stimulation of the Upper Limbs in Stroke Patients During Short Rehabilitation Programm
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.
Read the 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).
- Being tested
- FPS group, Conventional therapy group
- Keywords
- functional proprioceptive stimulation, rehabilitation, spasticity, stroke
- Medical subject headings
- Stroke, Motor Disorders, Paresis, Muscle Weakness, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPS groupDevice
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.
Conventional therapy groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline at 3 weeks
Secondary outcomes (4)
Fugl-Meyer Assessment Scale for upper extremity assessment
Functionality of the upper limbs were assessed using the FMA - Fugl-Meyer Assessment Scale for upper extremity assessment (FMA-UE). In this study, we used 36 items of the upper arm (proximal musculature, FMA-UA), 24 items of wrist and hand (distal musculature, FMA-W/H), 6 items of aspects of coordination, 12 items of aspects of sensation, 24 items of aspects of passive joint movement, 24 items of joint pain. So the maximum total score on this FMA-UE scale was 126 points.
Measured: Change from baseline at 3 weeks
Frenchay Arm Test
Frenchay Arm Test is designed to assess the motor skills of the upper limbs with central paresis [29]. This test includes five tasks, for each successfully completed task the patient receives 1 point, for unfulfilled - 0 points, maximum 5 points.
Measured: Change from baseline at 3 weeks
The Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
Measured: Change from baseline at 3 weeks
The Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) it is a digital version of the visual-analog scale (Visual Analog Scale for pain, VAS). It is a horizontal line, 10 cm long, with numbers from 0 to 10 located on it, where 0 is "no pain", 5 is "moderate pain" and 10 is "the strongest pain imaginable".
Measured: Change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start20 Feb 2021
- Primary completion5 Apr 2023
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, single-blinded controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Galina Ivanova, Prof, Study chair, Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143475
- Sponsor's protocol ID
- Vibramoov Uper Limb 01
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shurupova M, Fuchizhi O, Ivanova G. Greater recovery of upper-limb function in stroke patients with repetitive functional proprioceptive stimulation compared to robotic mechanotherapy: a quasi-randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Jan 20;18(1):79. doi: 10.1186/s13102-025-01526-3.
PubMed 41555385
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetetive Sessions of Functional Proprioceptive Stimulation of the Upper Limbs in Stroke Patients During Short Rehabilitation Programm
- ClinicalTrials.gov ID
- NCT06143475
- Acronym / sponsor ID
- Vibramoov Uper Limb 01
- Keywords
- functional proprioceptive stimulation, rehabilitation, spasticity, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, single-blinded controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| FPS group | Experimental | Device: FPS groupIn 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. |
| Conventional therapy group | Active comparator | Other: Conventional therapy groupIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- presence in the rehabilitation program of other robotic methods
- violation of skin integument
- floating thrombosis
- pronounced cognitive deficit
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPS groupVibration 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. | Device | FPS group |
| Conventional therapy groupPatients 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 |
Primary outcome
Muscle strength
Time frame: Change from baseline at 3 weeks
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.
Muscle tone
Time frame: Change from baseline at 3 weeks
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.
4 secondary outcomes
Fugl-Meyer Assessment Scale for upper extremity assessment
Time frame: Change from baseline at 3 weeks
Frenchay Arm Test
Time frame: Change from baseline at 3 weeks
The Action Research Arm Test (ARAT)
Time frame: Change from baseline at 3 weeks
The Numeric Pain Rating Scale (NPRS)
Time frame: Change from baseline at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 41555385Shurupova M, Fuchizhi O, Ivanova G. Greater recovery of upper-limb function in stroke patients with repetitive functional proprioceptive stimulation compared to robotic mechanotherapy: a quasi-randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Jan 20;18(1):79. doi: 10.1186/s13102-025-01526-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galina Ivanova, Prof study chair
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPS group and Conventional therapy group in people with Stroke and Motor Disorders, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: Change from baseline at 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06143475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.