Health TrialsbyHealthPanel

Comprehensive Intensive Stroke Rehabilitation

ConditionsStrokeRehabilitationPhysical Therapy Modalities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCharles University, Czech Republic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

adults

after first ischemic stroke

early sub-acute phase

slight to moderately severe disability [2 - 4 on the Modified Rankin Scale]

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neuroproprioceptive "facilitation, inhibition"

    Behavioral

    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.

  • Technology based physical therapy

    Behavioral

    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.

  • Effectively managed rehabilitation implementing the recommendations of the World Health Organization

    Behavioral

    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.

  • Standard care

    Behavioral

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

Treatment groups

280 Participants
are divided into 4 treatment groups
Group A: Neuroproprioceptive "facilitation, inhibition"Active comparator 1 intervention
Group B: Technology based physical therapyActive comparator 1 intervention
Group C: Effectively managed rehabilitation implementing the recommendations of the World Health OrganizationExperimental treatment 1 intervention
Group D: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months

a 10 item scale that assesses an individual's physical, mental, and social health where a standardized score with a mean of 50 and a standard deviation of 10, so a person with a T-score of 40 is one SD below the mean.

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively)
2

Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 3 weeks, 3 and 12 months

the 36-item questionnaire, higher score means higher disability

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
3

Change from Baseline Goal Attainment scale at 3 weeks, 3 and 12 months

Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome.

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).

Secondary outcomes

1

Change from Baseline Jamar Hydraulic Hand Dynamometer at 3 weeks

isometric grip force and strength. The higher value, the better function (higher strength)

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
2

Change from Baseline a power of the signal in band from frequency 1 to 2 at 3 weeks

The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - a power of the signal in band from f1 to f2 - lower value, lower tremor.

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
3

Change from Baseline a frequency for which the smoothed power spectral density is maximal at 3 weeks

The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - a frequency for which the smoothed power spectral density is maximal - lower value, lower tremor.

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)
4

Change from Baseline Nine Hole Peg Test at 3 weeks

A client takes the pegs from a container, one by one, and places them into the holes on the board, as quickly as possible. Shorter times reflect better function.

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks)

Other outcomes

1

Change from Baseline the serum level of Long non-coding ribonucleic acid (lncRNA) at 3 weeks, 3 and 12 months

LncRNAs are defined as RNA transcripts \>200 nucleotides with limited coding potential, but multiple function of binding different DNA, mRNAs and proteins, and they can be expressed under different conditions. As an improvement will be interpreted a significant mean fold change in gene expression (≥ 2.0, p value ≤ 0.05) between two groups following endogenous gene standardisation and normalization through control adjustment to a value of 1.0.

Time frame
Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up at 3 and 12 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

Thomayer University Hospital

Collaborator

Academy of Science Czech Republic

Collaborator

Ministry of Health, Czech Republic

Collaborator

Vascular surgery, University hospital Královské Vinohrady, Prague

Collaborator

Source ClinicalTrials.gov
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