Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID05323916

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

Led by Charles University, Czech Republic · Updated on 2024-08-20

280

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

C

Charles University, Czech Republic

Lead Sponsor

T

Thomayer University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a Comprehensive Intensive Rehabilitation Program after stroke, based on the International Classification of Functioning, Disability and Health model. This study compares this program with two other rehabilitation approaches of the same length but different physical therapy content, as well as with a control group receiving standard care. The aim is to identify predictors of successful rehabilitation and to assess improvements from multiple perspectives, including patient-reported outcomes and clinical assessments.

CONDITIONS

Brief Title

Comprehensive Intensive Stroke Rehabilitation

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 85 years
  • After first ischemic stroke
  • In early sub-acute phase
  • Slight to moderately severe disability (score 2 to 4 on Modified Rankin Scale)
  • Pre-stroke disability score of 0 to 2 on Modified Rankin Scale
  • Able to participate in 4 hours of comprehensive rehabilitation daily
  • Minimal or moderate motor deficit of upper or lower limbs (NIHSS Item 5 or 6 scores 1-3)
  • Able to perform daily living activities prior to stroke (score 0 to 2)
  • Native Czech speaker or equivalent proficiency
Not Eligible

You will not qualify if you...

  • Low level of consciousness or severe cognitive decline preventing test completion
  • Severe visual or hearing impairments affecting test participation
  • Behavioral disorders or lack of cooperation with therapist
  • Severe medical conditions with poor prognosis such as advanced cancer, severe frailty, fractures, or serious cardiovascular and respiratory diseases

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

Duration - 3 weeks

Participants undergo a comprehensive intensive rehabilitation program tailored to their assigned group, involving 3 to 4 hours of daily therapy focused on motor recovery and functional improvement after stroke.

Daily therapy sessions during the 3-week program

Follow-up

Duration - Up to 12 months after treatment

Participants are assessed to evaluate their recovery and rehabilitation outcomes at several time points after completing the treatment.

3 visits (at 3 weeks, 3 months, and 12 months after admission)

Trial Site Locations

Total: 1 location

1

Thomayer University Hospital

Prague, Czechia, 140 59

Actively Recruiting

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Research Team

K

Kamila Řasová, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

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.

Řasová K, Martinková P, Vařejková M...

https://pubmed.ncbi.nlm.nih.gov/39507626

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.

Kamila Řasová, Patrícia Martinková, Michaela Vařejková...

https://pubmed.ncbi.nlm.nih.gov/36388199