NCT05323916

Comprehensive Intensive Stroke Rehabilitation

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aim of this study is to define the predictors of effective rehabilitation after stroke. In order to compare the improvement from many different aspects, a wide range of patient characteristic, self-report measures and clinical assessments according to framework of the International Classification of Functioning, Disability and Health (ICF) model, and other data will be collected. The investigators consider, as the most important aspect, the subjective feelings of the participants about how they improved. Therefore, the Goal Attainment scale together with the Patient-reported Outcomes Measurement Information Global Health, and the World Health Organization Disability Assessment Schedule were chosen as primary outcomes. As secondary outcomes, will be measured the motor, cognitive, psychological, speech and swallowing functions and the functional independence. Moreover, focus will be placed on the identification of novel biological molecules reflective of effective rehabilitation. This clinical trial will test the following scientific hypotheses: I. COMIRESTROKE under all three settings has a positive influence on all outcomes and higher effect than control group. . II. COMIRESTROKE - ICF will have the highest impact on primary outcomes (GAS, PROMIS, WHODAS 2.0) and on such secondary outcomes that were identified as treatment goals. Furthermore, it is expected that the highest impact will be on the primary outcomes in the follow-up (three and twelve months after finishing the rehabilitation). III. COMIRESTROKE - NEFI will have the highest effect on the secondary outcomes, mainly on motor functions. Moreover, it will most significantly lead to the initiation of plastic and adaptive processes, assessed by the level of lncRNAs in the peripheral blood. IV. The most important predictor of effective rehabilitation will be the level of disability at admission time; however, the content of the rehabilitation will have an impact on perceived, clinical, and physiological changes of the rehabilitant.

Conditions

• Stroke
• Rehabilitation
• Physical Therapy Modalities

Interventions

Type	Name	Description
BEHAVIORAL	Neuroproprioceptive "facilitation, inhibition"	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.
BEHAVIORAL	Technology based physical therapy	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.
BEHAVIORAL	Effectively managed rehabilitation implementing the recommendations of the World Health Organization	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.
BEHAVIORAL	Standard care	Participants will undergo standardly provided care including face to face physiotherapy (bed mobility, transfers, gait, therapeutic exercises, positioning, education).

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-06-15
• Completion: 2026-01-15
• First posted: 2022-04-12
• Last updated: 2024-08-20

Locations

1 site across 1 country: Czechia