Intensive rehabilitation program for stroke recovery

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

This study is testing a new intensive rehabilitation program for stroke patients to see if it helps them recover better than standard care and other modern approaches.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Charles University, Czech Republic (other)
• Locations: 1 site (Prague)
• Trial ID: NCT05323916 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a Comprehensive Intensive Rehabilitation Program for stroke patients, comparing it with two other rehabilitation approaches that utilize modern technology and neuroproprioceptive techniques. The program is designed to assess various aspects of recovery, including motor, cognitive, psychological, and functional independence, using a range of patient-reported outcomes and clinical assessments. The study aims to identify predictors of effective rehabilitation and the subjective experiences of participants regarding their improvement. Participants will receive either the comprehensive program or standard care, with outcomes measured at multiple time points.

Who should consider this trial

Good fit: Ideal candidates are adults who have experienced their first ischemic stroke and have slight to moderately severe disabilities.

Not a fit: Patients with severe cognitive decline, low consciousness, or significant behavioral disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly enhance recovery outcomes for stroke patients, leading to improved quality of life.

How similar studies have performed: Other studies have shown promise in using intensive rehabilitation approaches for stroke recovery, but this specific combination of techniques is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Where this trial is running

Prague

• Thomayer University Hospital — Prague, Czechia (RECRUITING)

Study contacts

• Principal investigator: Kamila Řasová, Dr. — Charles University, Czech Republic
• Study coordinator: Kamila Řasová, Dr.

Conditions: Stroke, Rehabilitation, Physical Therapy Modalities, Technology, Goals, Neuroproprioceptive "facilitation and inhibition"