RecruitingNot ApplicableNCT05323916

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


Sponsor

Charles University, Czech Republic

Enrollment

280 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria9

  • adults
  • after first ischemic stroke
  • early sub-acute phase
  • slight to moderately severe disability \[2 - 4 on the Modified Rankin Scale\]
  • 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 Criteria3

  • 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)

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Interventions

BEHAVIORALNeuroproprioceptive "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.

BEHAVIORALTechnology 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.

BEHAVIORALEffectively 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.

BEHAVIORALStandard care

Participants will undergo standardly provided care including face to face physiotherapy (bed mobility, transfers, gait, therapeutic exercises, positioning, education).


Locations(1)

Thomayer University Hospital

Prague, Czechia

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NCT05323916


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