Comprehensive Intensive Stroke Rehabilitation

NCT05323916 | Recruiting

• 1 other identifier: 12021
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators aim to assess the effectiveness of the Comprehensive Intensive Rehabilitation Program After Stroke implementing the International Classification of Functioning, Disability and Health model, and to compare it with two cohorts receiving Comprehensive Intensive Rehabilitation Program After Stroke of the same length but different in physical therapy content (program implementing modern technological approach and neuroproprioceptive "facilitation and inhibition"). Moreover, control group will undergo standard care.

Conditions

Stroke; Rehabilitation; Physical Therapy Modalities

Keywords

Technology; Goals; Neuroproprioceptive "facilitation and inhibition"

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months

  a 10 item scale that assesses an individual's physical, mental, and social health where a standardized score with a mean of 50 and a standard deviation of 10, so a person with a T-score of 40 is one SD below the mean.

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively)

• Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 3 weeks, 3 and 12 months

  the 36-item questionnaire, higher score means higher disability

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).

• Change from Baseline Goal Attainment scale at 3 weeks, 3 and 12 months

  Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome.

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).

Secondary Outcomes (19)

• Change from Baseline Jamar Hydraulic Hand Dynamometer at 3 weeks

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)

• Change from Baseline a power of the signal in band from frequency 1 to 2 at 3 weeks

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)

• Change from Baseline a frequency for which the smoothed power spectral density is maximal at 3 weeks

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)

• Change from Baseline Nine Hole Peg Test at 3 weeks

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)

• Change from Baseline Action Research Arm Test at 3 weeks

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)

Other Outcomes (1)

• Change from Baseline the serum level of Long non-coding ribonucleic acid (lncRNA) at 3 weeks, 3 and 12 months

  Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up at 3 and 12 months.

Study Arms (4)

Neuroproprioceptive "facilitation, inhibition"

ACTIVE COMPARATOR

According to the doctor's indication, a multidisciplinary team participates in the program. The practitioner from each clinical field (rehabilitation and physical medicine, physiotherapy, occupational therapy, clinical speech therapy and psychology) selects appropriate treatment methodologies for each patient (three hours). In addition, participants undergoes one hour a day of individual physiotherapy on a neurophysiological basis - neuroproprioceptive "facilitation, inhibition", which, by combining appropriate stimuli in a suitable time sequence, maintains optimal motor pathway function and optimal irritability of control or regulation structures.

Behavioral: Neuroproprioceptive "facilitation, inhibition"

Technology based physical therapy

ACTIVE COMPARATOR

According to the doctor's indication, a multidisciplinary team participates in the program. The practitioner from each clinical field (rehabilitation and physical medicine, physiotherapy, occupational therapy, clinical speech therapy and psychology) selects appropriate treatment methodologies for each patient (three hours). In addition, they will undergo physiotherapy for an hour a day using the implementation of modern technologies based on the principles of sensorimotor learning, i.e. repeating specific and targeted functions in different environments / conditions in order to strengthen the memory footprint and initiate structural changes in the central nervous system. According to the indication, participants will be offered one of the robotic systems using an exoskeleton (Gloreha, Erigo and Meditutor, Lokomat and Ekso) or a therapy using virtual environment.

Behavioral: Technology based physical therapy

Effectively managed rehabilitation implementing the recommendations of the World Health Organization

EXPERIMENTAL

The concept of therapy implementing the ICF model is based on a comprehensive, so-called biopsychosocial approach to the patient and his/her disease (four hours). The key is to set individual goals of the therapy together with the rehabilitator and with the use of so-called ICF core sets, which individually take into account the given situation of the rehabilitated person. This approach includes interdisciplinary diagnosis of the current condition, i.e. not only based on the diagnosis, but also on the functional status and activities performed, it also takes into account the socio-psychological background of the patient.

Behavioral: Effectively managed rehabilitation implementing the recommendations of the World Health Organization

Control group

PLACEBO COMPARATOR

Participants will undergo standard care.

Behavioral: Standard care

Interventions

Neuroproprioceptive "facilitation, inhibition" BEHAVIORAL

Participants will undergo a standard comprehensive intensive rehabilitation program three hours a day for three weeks and moreover one hour a day of neuroproprioceptive "facilitation, inhibition" physical therapy.

Neuroproprioceptive "facilitation, inhibition"

Technology based physical therapy BEHAVIORAL

Participants will undergo a standard comprehensive intensive rehabilitation program three hours a day for three weeks and moreover one hour a day of technology based physical therapy.

Technology based physical therapy

Effectively managed rehabilitation implementing the recommendations of the World Health Organization BEHAVIORAL

Participants will undergo a four hour a day for three weeks of effectively managed comprehensive intensive rehabilitation implementing the recommendations of the World Health Organization.

Effectively managed rehabilitation implementing the recommendations of the World Health Organization

Standard care BEHAVIORAL

Participants will undergo standardly provided care including face to face physiotherapy (bed mobility, transfers, gait, therapeutic exercises, positioning, education).

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults
• after first ischemic stroke
• early sub-acute phase
• slight to moderately severe disability \[2 - 4 on the Modified Rankin Scale\]
• on the Pre-Stroke Modified Rankin Score
• potential to accept 4 hours of comprehensive rehabilitation per day and to profit from physiotherapy
• minimal or moderate motor deficit of upper or lower extremities (on NIHSS Item 5 or 6 scores 1-3 points)
• able to perform activities of daily living prior to stroke event (0 - 2 on the Pre-Stroke Modified Rankin Score)
• Czech is participants' native language or its knowledge is at the level of the mother tongue

You may not qualify if:

• low level of consciousness (vegetative state and/or minimally conscious state); severe cognitive decline that would interfere with administration of the tests, premorbid illiteracy, severe visual and/or auditory deficit that would prevent proper completion of the tests
• behavioural disorders and/or lack of cooperation with therapist
• severe medical problems with a poor prognosis, (e.g., severe frailty, advanced and incurable cancer, fracture, cardiovascular disorders as chronic heart failure NYHA III, IV, symptomatic coronary artery disease Angina Severity Class III, IV, respiratory insufficiency as chronic obstructive pulmonary disease GOLD IV, and other severe disease)

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Thomayer University Hospital: collaborator
• Academy of Science Czech Republic: collaborator
• Ministry of Health, Czech Republic: collaborator
• Vascular surgery, University hospital Královské Vinohrady, Prague: collaborator

Study Sites (1)

Thomayer University Hospital

Prague, 140 59, Czechia

RECRUITING

Related Publications (2)

• K R, P M, M V, B M, J H, D H, D I, L L, R V, J Z, J B, V M, T P. Improvements in upper extremity isometric muscle strength, dexterity, and self-care independence during the sub-acute phase of stroke recovery: an observational study on the effects of intensive comprehensive rehabilitation. Front Neurol. 2024 Oct 23;15:1442120. doi: 10.3389/fneur.2024.1442120. eCollection 2024.

  PMID: 39507626 DERIVED

• Rasova K, Martinkova P, Varejkova M, Miznerova B, Pavlikova M, Hlinovska J, Hlinovsky D, Philippova S, Novotny M, Pospisilova K, Biedkova P, Vojikova R, Havlik J, O'Leary VB, Cerna M, Bartos A, Philipp T. COMIRESTROKE-A clinical study protocol for monitoring clinical effect and molecular biological readouts of COMprehensive Intensive REhabilitation program after STROKE: A four-arm parallel-group randomized double blinded controlled trial with a longitudinal design. Front Neurol. 2022 Nov 1;13:954712. doi: 10.3389/fneur.2022.954712. eCollection 2022.

  PMID: 36388199 DERIVED

MeSH Terms

Conditions

Stroke; Inhibition, Psychological

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kamila Řasová, Dr.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamila Řasová, Dr.

CONTACT

+420604511416; kamila.rasova@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients meeting the above criteria will be invited to participate and asked to provide a written informed consent. They will be randomly assigned (1:1:1:1) as soon as possible, but always within 48 hours of admission, into one of the four interventions (represented by Group 1, 2, 3 or 4) using offsite-independent randomization protocols (www.randomization.com). Concealed allocation will be performed using sequentially numbered opaque sealed envelopes only accessible by research personnel with no involvement in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor PhDr. Kamila Řasová, Ph.D.

Model Details: Randomised Double Blinded Controlled Trial with a longitudinal design

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: April 12, 2022
• Study Start: May 1, 2022
• Primary Completion: June 15, 2025
• Study Completion: January 15, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Done now: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) 2023 - 2024 Clinical Study Report (CSR) Analytic Code
• Access Criteria: Researcher can write us for access to data code.

Locations

CZ (1)