What is this study trying to find out about stroke rehabilitation?

This study aims to compare different intensive rehabilitation programs after stroke to see which approach leads to better recovery in physical, cognitive, and psychological functions. Researchers want to understand how these therapies affect patient outcomes and identify factors that predict effective rehabilitation. The study is sponsored by Charles University in the Czech Republic.

Who may be eligible for this stroke rehabilitation clinical trial?

Adults aged 18 to 85 who have experienced their first ischemic stroke in the early sub-acute phase may be eligible. Participants should have slight to moderately severe disability and be able to engage in four hours of rehabilitation daily. They must also speak Czech well. Please review eligibility criteria for more details.

Is there any cost to participate in this stroke rehabilitation clinical trial?

Study-related care, including the rehabilitation programs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider these factors when joining the trial.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 85Years

All Genders

ID05323916

Stroke Recovery Study Comparing Three Intensive Rehabilitation Programs Including WHO Model and Technology-Based Therapy

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

280

Participants Needed

Research Sites

30 weeks

Total Duration

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

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

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

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)

Research Team

Kamila Řasová, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

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Frequently Asked Questions

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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/

Stroke Recovery Study Comparing Three Intensive Rehabilitation Programs Including WHO Model and Technology-Based Therapy

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Testing Caregiver-Assisted Strategy Training to Improve Dail...

Study of Brain-Triggered Muscle and Tongue Stimulation to Im...

Digital Treatment Using iPad-Based Training and Coaching to ...

Frequently Asked Questions

What is this study trying to find out about stroke rehabilitation?

Who may be eligible for this stroke rehabilitation clinical trial?

Is there any cost to participate in this stroke rehabilitation clinical trial?

How are participants assigned to study groups in this stroke rehabilitation trial?

What outcomes will the researchers measure during this stroke rehabilitation study?

What happens after this stroke rehabilitation clinical trial ends?

Can I leave this stroke rehabilitation clinical trial if I change my mind?

Not the Right Trial for You?

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.

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.

On this page

Sponsors

Sponsors

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Testing Caregiver-Assisted Strategy Training to Improve Dail...

Study of Brain-Triggered Muscle and Tongue Stimulation to Im...

Digital Treatment Using iPad-Based Training and Coaching to ...

Frequently Asked Questions

What is this study trying to find out about stroke rehabilitation?

Who may be eligible for this stroke rehabilitation clinical trial?

Is there any cost to participate in this stroke rehabilitation clinical trial?

How are participants assigned to study groups in this stroke rehabilitation trial?

What outcomes will the researchers measure during this stroke rehabilitation study?

What happens after this stroke rehabilitation clinical trial ends?

Can I leave this stroke rehabilitation clinical trial if I change my mind?

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.

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.

Sponsors