Motor Recovery Following the Comprehensive Intensive Rehabilitation Program After Stroke Implementing the International Classification of Functioning, Disability and Health Model: A Randomized Controlled Trial Protocol

Status: Recruiting
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• adults

• after first ischemic stroke

• early sub-acute phase

• slight to moderately severe disability \[2 - 4 on the Modified Rankin Scale\]

• 0 - 2 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

Contact Information
Primary
Kamila Řasová, Dr.
kamila.rasova@gmail.com
+420604511416
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 280
Treatments
Active_comparator: Neuroproprioceptive facilitation, inhibition
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.
Active_comparator: Technology based physical therapy
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.
Experimental: Effectively managed rehabilitation implementing the recommendations of the World Health Organization
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.
Placebo_comparator: Control group
Participants will undergo standard care.
Related Therapeutic Areas
Sponsors
Leads: Charles University, Czech Republic
Collaborators: Vascular surgery, University hospital Královské Vinohrady, Prague, Ministry of Health, Czech Republic, Academy of Science Czech Republic, Thomayer University Hospital

This content was sourced from clinicaltrials.gov