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The Pilot Project Development Of MEdical Rehabilitation System in Russian Federation

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ClinicalTrials.gov Identifier: NCT02793934
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
Ministry of Health, Russian Federation
Pirogov Russian National Research Medical University
Voino-Yasenetsky Krasnoyarsk State Medical University
Vladivostok State Medical University
Ural district Institute of Brain
Nizhegorodskoye Federal State Unitary Enterprise
Information provided by (Responsible Party):
St. Petersburg State Pavlov Medical University

Brief Summary:

The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

  1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology)
  2. Acute myocardial infarction (AMI, specialty cardiology)
  3. Patients after total hip replacement (THR, specialty orthopaedia) The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).

Condition or disease Intervention/treatment
Stroke AMI Total Hip Replacement Other: Scales Other: New model of rehabilitation Other: Old model of rehabilitation Other: ICF reader

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Development Of MEdical Rehabilitation inRussia Pilot Project
Study Start Date : September 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
1st phase
In the 1st phase of the study the staff of the medical organizations continue to work in the familiar "old" scheme, but using the set of scales.
Other: Scales

For stroke patients there are used scales:

Modified Rankin Scale, NIH Stroke Scale , Glasgow Coma Scale, Dysphagia Severity, Rating Scale Speech or Language Impairment Severity Rating Scale, Modified Rivermead Mobility Index, Berg Balance Scale, Modified Ashworth Scale, Medical Research Council Scale, Frenchay Arm Test, Montreal Cognitive Assessment Scale, Spielberger Scale, Beck's Depression Inventory, Visual Analogue Scale, Functional Independence Measure For patients after AMI: Rankin scale, GRACE scale, MoCA, VAS, Hospital scale of anxiety and depression, Canadian classification if stenocardia

For patients after THR:

The pain of the operated joint on VAS scores The Harris scale (the total amount), Scale Lequesne (total), Hospital scale of anxiety


Other: Old model of rehabilitation
Other: ICF reader
2nd phase
In the 2nd phase, medical organizations will start to work on a new model with the implementation of problem-oriented multidisciplinary approach and the use of modern rehabilitation technologies. There is planning to use clearly defined criteria for transfer from stage to stage, developed by the professional community. When doctors will be trained program "ICF-reader" will have an opportunity to establish a rehabilitation diagnosis on the basis of the ICF, and the option for ICF assessment using rating scales.
Other: Scales

For stroke patients there are used scales:

Modified Rankin Scale, NIH Stroke Scale , Glasgow Coma Scale, Dysphagia Severity, Rating Scale Speech or Language Impairment Severity Rating Scale, Modified Rivermead Mobility Index, Berg Balance Scale, Modified Ashworth Scale, Medical Research Council Scale, Frenchay Arm Test, Montreal Cognitive Assessment Scale, Spielberger Scale, Beck's Depression Inventory, Visual Analogue Scale, Functional Independence Measure For patients after AMI: Rankin scale, GRACE scale, MoCA, VAS, Hospital scale of anxiety and depression, Canadian classification if stenocardia

For patients after THR:

The pain of the operated joint on VAS scores The Harris scale (the total amount), Scale Lequesne (total), Hospital scale of anxiety


Other: New model of rehabilitation
Other: ICF reader



Primary Outcome Measures :
  1. Mortality [ Time Frame: through study completion, an average of 1 month ]
  2. Recovery of functions, activity and participation [ Time Frame: through study completion, an average of 1 month ]
    modified Renkin scale)


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 90 days after discharge ]
  2. Recovery of functions, activity and participation [ Time Frame: 90 days after discharge ]
  3. Environmental adaptation [ Time Frame: 90 days after discharge ]
  4. Preventable conditions [ Time Frame: 90 days after discharge ]
    Pain Trophic disturbances Muscle tonus disturbances Contractures Cognitive disorders Inadequate tolerance Social disadaptation etc

  5. Time of start of rehabilitation [ Time Frame: through study completion, an average of 1 month ]
  6. Time of the first, interim and final expert assessment of rehabilitation potential [ Time Frame: through study completion, an average of 1 month ]
  7. Duration of hospitalization [ Time Frame: through study completion, an average of 1 month ]
  8. Duration of rehabilitation process for the achievement the goals for each stage of rehabilitation [ Time Frame: through study completion, an average of 1 month ]
  9. Duration of rehabilitation process from onset of disease to final or to transfer the patient or to establishing the disability [ Time Frame: through study completion, an average of 1 month ]

Other Outcome Measures:
  1. Criteria of rehabilitation potential [ Time Frame: up to 6 months ]
  2. Criteria for the transferring to the next stage or to another hospital [ Time Frame: up to 6 months ]
  3. Case mix groups on basic functional disturbances (by ICF) [ Time Frame: up to 6 months ]
  4. Criteria for the transferring to the palliative or nursing care [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology) Acute myocardial infarction (AMI, specialty cardiology) Patients after total hip replacement (THR, specialty orthopaedia)

Criteria

Inclusion Criteria:

  • Age over 18 years old
  • Ischemic stroke or intracerebral hemorrhage
  • Patients with acute myocardial infarction with elevation of segment ST (STMI)
  • Total hip replacement caused by degenerative processes

Exclusion Criteria:

  • uncorrected metabolic diseases (diabetes mellitus, myxoedema, thyrotoxicosis);
  • III hepatic or pancreatic insufficiency
  • heavy or repeated hemorrhages of any reason or anaemia Hb<80g/l;
  • parasitoses;
  • acute infectious disease;
  • active stage of any form of tuberculosis;
  • patients with transmissible sexual diseases;
  • mental illness with personality desocialisation;
  • complicate ventricular rhythm disturbances
  • high risk of thromboembolism
  • absence of motivation
  • decompensation of somatic functions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793934


Contacts
Contact: Ivanova Galina, Professor +79161144504 reabiivanova@mail.ru
Contact: Melnikova Elena, Professor +7 (911) 743-15-08 melnikovae2002@mail.ru

Locations
Russian Federation
StPetersburgSPMU Recruiting
Saint Petersburg, Russian Federation, 197022
Contact: Elena V. Melnikova, MD, Ph.D    +7117431508    melnikovae2002@gmail.com   
Contact: Alexey A. Shmonin, Ph.D    +79213568136    langendorff@gmail.com   
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University
Ministry of Health, Russian Federation
Pirogov Russian National Research Medical University
Voino-Yasenetsky Krasnoyarsk State Medical University
Vladivostok State Medical University
Ural district Institute of Brain
Nizhegorodskoye Federal State Unitary Enterprise
Investigators
Principal Investigator: Shmonin Alexey, PhD St. Petersburg State Pavlov Medical University
Principal Investigator: Shamalov Nikolay, Professor Pirogov Russian National Medical Research University
Principal Investigator: Suvorov Andrey, PhD Pirogov Russian National Medical Research University
Principal Investigator: Buylova Tatiana, Professor Rehabilitation Center of Federal State Unitary Enterprise Nizhegorodskoye PROP
Principal Investigator: Tsykunov Mikhail, Professor Central Research Institute of Traumatology and Orthopedics . Priorov Russian Ministry of Health
Principal Investigator: Belyaev Anatoliy, Professor Vladivostok State Medical University
Principal Investigator: Prokopenko Sergei, Professor Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
Principal Investigator: Khasanova Dina, Professor Kazan State Medical University Russian Ministry of Health
Principal Investigator: Bodrova Rezeda, PhD Kazan State Medical Academy
Principal Investigator: Aronov David, Professor State Research Center for Preventive Medicine Health Ministry of Russia
Principal Investigator: Bubnova Marina, Professor State Research Center for Preventive Medicine Health Ministry of Russia
Principal Investigator: Belkin Anatoliy, Professor Ural State Medical University Russian Ministry of Health
Principal Investigator: Mishina Irina, Professor Ivanovo State Medical Academy Russian Ministry of Health
Principal Investigator: Sarana Andrey, PhD Saint-Petersburg City Hospital № 40 of Recreation Area
Principal Investigator: Ivanova Natalya, Professor Russian Research Neurosurgical Polenovs Institute
Principal Investigator: Yashkov Alexander, Professor Samara State Medical University
Principal Investigator: Maltseva Mariya, Professor St. Petersburg State Pavlov Medical University
Principal Investigator: Soloveva Liudmila, MD St. Petersburg State Pavlov Medical University

Additional Information:
ICF  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT02793934     History of Changes
Other Study ID Numbers: DOME
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Petersburg State Pavlov Medical University:
Rehabilitation
ICF
Pilot project
Stroke
Acute myocardial infarction
Total hip replacement