About this trial
The aim of the study is to obtain knowledge of the impact of basal stimulation therapy on the health status of adults suffering from schizophrenia and requiring permanent institutional care.
The use of basal stimulation therapy in many European centres for several decades, combined with the limited amount of scientific evidence, justifies undertaking the proposed research. Available evidence indicates reduced anxiety and improved quality of life. No such studies have previously been conducted in institutionalized patients with schizophrenia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
women and men aged ≥ 55 years,
consent of the legal guardian/caregiver to participate in the study,
schizophrenia clinically confirmed for at least 5 years, with predominance of negative symptoms,
stable drug therapy (treatment unchanged for at least 3 months)
Disqualifiers
lack of consent to participate in the study;
pregnancy
general contraindications (acute inflammatory conditions and diseases accompanied by fever, venous thrombosis, unstable arterial hypertension , early condition after contrast-enhanced computed tomography, early condition after lumbar puncture, general serious condition of the patient )
exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, visual seizures)
Trial design
Crossover
Treatments tested in this trial
physiotherapy, 2 x a week for 6 weeks
Other interventionOnly comprehensive and differentiated interventions provide the best care for people with special needs. Basal stimulation complements physiotherapy perfectly. The group will receive standard physiotherapy based on best clinical practice principles.
basal therapy, 2 x a week for 6 weeks
Other interventionbasal therapy, 2 x a week for 6 weeks The aim of basal therapy will be to help patients with profound disabilities compensate for the lack of their own life experiences, including independent movement and interaction with the environment, strengthening the meaning and purpose of individual movements, stimulating movements, even minimal ones, and entering into contact with the external environment through various types of stimulation, offering numerous environmental stimuli and multi-sensory experiences that will facilitate awareness of one's own existence. Each session will include: 1. preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems, 2. careful observation and appropriate care of the patient, 3. grading of stimuli and their appropriate stimulation, 4. recording the therapist's comments on the therapy card.
Standard therapy group
Other interventionBoth groups will receive standard therapy based on best clinical practice principles for 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Primary Outcome Measures - GCS
Cognitive function testing with Glasgow coma scale (GCS). The Glasgow Coma Scale (GCS) measure patient' consciousness and cognitive functioning based on three specific checks: eye opening, verbal response, and motor response. The total score ranges from 3 to 15, where 15 means fully awake and 3 means deep unresponsiveness.
Primary Outcome Measures - CRS-R
Cognitive function testing with Coma Recovery Scale (CRS-R) The Coma Recovery Scale-Revised (CRS-R) ranges from 0 to 23 points across six subscales (Auditory, Visual, Motor, Oromotor/Verbal, Communication, and Arousal). Higher scores indicate higher levels of conscious awareness.
Primary Outcome Measures - blood test
Blood concentration testing for selected biological factors. Patients will have 5 ml of venous blood drawn twice (before and after completing the exercise) to perform the blood test.
Secondary outcomes
Secondary Outcome Measure - EEG
EEG examination (changes in the bioelectric activity of the brain). Changes or abnormalities in the wave patterns will help to identify conditions like epilepsy. The assessment will include core brain rhythms and frequencies in alpha waves (8-13 Hz): standard resting rhythm seen when a person is awake with eyes closed and abnormalities in the wave patterns e.g. spikes and sharp waves, spike-and-wave discharges (combined sharp spikes and slow waves, often seen at a 3-Hz frequency in absence seizures), focal discharges (abnormal activity arising from one specific area of the brain), generalized discharges (widespread abnormal electrical patterns across both hemisphere).
Other outcomes
Barthel scale
The Barthel Scale is a popular medical tool used to assess a patient's independence in 10 basic activities of daily living, such as eating, dressing, and using the toilet. The maximum score is 100 points, and the score indicates the patient's need for assistance from others. Interpretation of scores: 85-100 points: good condition, the patient is independent. 21-84 points: moderate or moderately severe disability, the patient requires varying degrees of assistance. 0-20 points: severe disability, the patient is completely dependent on others (a score of 40 or less qualifies the patient for long-term care).
Emotional state observation
Observation of the emotional state (movements of limbs, opening of eyes, eyelids). An emotional state movements with physical expressions, specifically through limb movements, eye opening and eyelid positions. These nonverbal cues reflect internal feelings.
Sponsors and contacts
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The Jerzy Kukuczka Academy of Physical Education in Katowice
Lead sponsor
Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
Collaborator
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