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SCHIZOPHRENIA 1 (Disorder)NCT07769749

Basal Stimulation Therapy in Adults With Schizophrenia Requiring Institutional Care

A study testing physiotherapy, 2 x a week for 6 weeks, basal therapy, 2 x a week for 6 weeks and Standard therapy group in people with SCHIZOPHRENIA 1 (Disorder), run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 2 sites in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
SCHIZOPHRENIA 1 (Disorder)
What is being tested?
physiotherapy, 2 x a week for 6 weeks, basal therapy, 2 x a week for 6 weeks and Standard therapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesPoland
Study dates
1 Sep 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study inclusion criteria:

  • 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)
  • functional ability of everyday life on the Barthel scale below 40 points.

The exclusion criteria from the study will be:

  • 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)
  • active cancer;
  • diseases of the nervous system (neuropathies, stroke , damage to the cerebellum, labyrinth) causing altered sensitivity to stimuli;
  • diseases and illnesses of the musculoskeletal system that significantly disturb the body's balance and the mobility of the limbs;
  • pressure ulcers grade IV and V on the Torrance scale.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Poland2 sites
  • Jerzy Kukuczka Academy of Physical Education in Katowice, Poland

    Katowice, Silesian Voivodeship, 40-065

    Laura Piejko, PT, PhD, 32 207 51 10, l.piejko@awf.katowice.pl

    Laura Piejko, PT, PhD

  • Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland

    Rybnik, Silesian Voivodeship, 44-200

    Alicja Kosmalska, MD, 032 43 28 217, alicja.kosmalska@psychiatria.com

    Laura Piejko, PT, PhD, 032 43 28 185, laura.piejko@psychiatria.com

Other trials in Poland

About this study

Official title: The Impact of Basal Stimulation Therapy in Adult Patients With Schizophrenia Requiring Permanent Institutional Care

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.

Read the detailed description

Basal stimulation (also referred to as basal therapy) was developed by Prof. Andreas Fröhlich in the 1970s in Germany, at the Special Care Center (Landstuhl).

Basal stimulation defines the approach and work with individuals with profound disabilities. The world of individuals with profound disabilities is very limited and focused primarily on close physical contact, which provides them with (usually minimal) opportunities to explore their surroundings. Therapy allows the patient to interact with their surroundings and experience a variety of stimuli, and is based primarily on nonverbal communication while simultaneously ensuring the patient's physical activity.

The goal of this method, in addition to multisensory stimulation, is primarily to provide individuals with profound disabilities with physical activity (even minimal) while simultaneously stimulating the cerebral motor cortex. As a result, the profoundly disabled person is helped to connect with their own body and the outside world. This, in turn, facilitates the therapeutic process between the patient and the outside world.

Furthermore, basal stimulation focuses on creating an appropriate, harmonious environment in daily life. This is achieved through appropriate stimulation or relaxation. The patient responds to the stimuli, allowing them to not only decide about the basal therapy process but also experience themselves, feel the boundaries of their body, and perceive the outside world. Basal stimulation also helps reduce stress and aggression. Each intervention aims to meet the real needs of a person with profound disabilities.

The study will assess the impact of basal therapy on the health of adults suffering from schizophrenia who require institutional care (profoundly disabled).

Legal guardians of patients meeting the study inclusion criteria will be informed in writing about the purpose and course of the study. They will also be informed that they can withdraw from the study at any stage without providing a reason and without affecting their subsequent treatment.

The patients will be divided into two experimental groups of six (1 and 2).

An AB/BA crossover experimental design will be conducted, where:

A - standard therapy + physiotherapy, 2 x a week for 6 weeks. B - standard therapy + basal therapy, 2 x a week for 6 weeks. Patients in group 1 will receive AB therapy, Patients in group 2 will receive BA therapy. The total duration of the study will be 12 weeks and include 12 patients.

Group allocation will be random, and the allocation method will be kept confidential to the physician qualifying patients for the study, medical staff, and patients. Group allocation will be performed by the study director, who will not have direct contact with patients before group allocation. Group allocation will be performed using block randomization.

Therapy Methods Both groups will receive standard therapy based on best clinical practice principles for 12 weeks. Additionally, the experimental groups will receive basal therapy (for 6 weeks) and physiotherapy (for the next 6 weeks) twice a week (for 30 minutes).

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.

Basal therapy is based on several types of stimulation:

  1. Somatic stimulation, which is based on the experience of touch and involves body and facial massage. Somatic stimulation also supports body symmetry and biological rhythm, improves breathing rhythm, strengthens the sense of security, and coordinates tension and relaxation. In somatic stimulation, it is important to respond to every slight movement of the patient, adapting the pressure and pace of the massage to their reactions and responding to them, which facilitates the development of various forms of communication with the patient.
  2. Oral stimulation, which allows for the experience of oral sensations (related to the mouth). This stimulation can be performed during a facial massage. Taste stimulation is also a good option, even for those not on a traditional diet. Oral stimulation can be part of somatic stimulation. If possible, stimulation is also performed with the patient's hand. Oral stimulation increases the patient's competence in areas such as food intake and improves hand-eye coordination.
  3. Vibrational stimulation, which involves intense stimulation of the patient's entire body to enable deep perception. This allows the patient to also experience the boundaries of their body. This stimulation is conducted in several joints (usually six). This promotes body awareness, which is so important for patients with multiple disabilities. It is important that after a vibrational stimulation session, the patient has time alone to process the stimuli they have experienced. Vibrational stimulation enhances deep perception of their own body, improves the reception of motor stimuli, stimulates touch and grasping, regulates muscle tone, increases the frequency of voice use, and deepens and rhythmizes breathing.
  4. Vestibular and vestibular stimulation, which focuses on the experience of movement. It helps develop the ability to maintain a specific body position, develop a sense of orientation, and normalize muscle tone. Furthermore, it increases attention (including visual concentration), the experience of one's own body weight, and regulates emotional states.

Each session of basal therapy 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.

The therapy will be carried out in the following positions:

  1. The side-lying position improves respiratory function, allowing for harmonized breathing. Depending on the underlying problem, it can also reduce pain and prevent its progression, for example, in the case of hips with mild changes. It also makes the patient feel safer, which often helps during epileptic seizures. This position also allows for interaction with the environment, with another person, and for personal activity.
  2. The "nest" position on the back comes in two variants:
  3. the supine position - low nest - promotes relaxation and breathing regulation. Lying on the back facilitates back perception, provides a sense of security, allows for simultaneous activity with both arms and legs, provides a sense of body symmetry, promotes emotional stability, facilitates eye contact, and allows for various stimulations, including oral stimulation.
  4. supine position - high nest - when sitting on the seat, this position primarily provides a perception of the body's back, symmetry, and safety. It allows for, for example, oral or somatic stimulation. However, it also allows some patients to experience a higher position - " sitting down " , significantly influencing the emotional quality of perception (the world is different when viewed from a higher position than lying down).
  5. The therapists will only use the prone position in patients when there are no contraindications (e.g., tracheostomy, PEG). In basal therapy, the use of this position to encourage self-activity by activating the patient's hands. It also has a beneficial effect on the digestive system, improves breathing and head control, strengthens the body's midline, and supports the perception of the abdomen and torso.
  6. The sitting position allows the participants to perceive the world from a different 360% perspective, allows the participants to be active with their own hands (horizontally, vertically and under the participants feet), facilitates communication, facilitates visual integration, and facilitates feeding.
  7. Standing position - stabilizes and gives a sense of security, supports self-activity, integrates the sense of sight, enables the perception of the weight of one's own body - the experience of independent movement, activates exploration with hands.
  8. The so-called basal niche position. The basal niche is the place where the patient resides during basal experiences, a place where stimulation is arranged and provided. Necessary aids are used to create the niche, including mattresses-a soft mattress for spastic individuals, a hard mattress for hypotonic individuals-therapeutic bananas, basal pillows, basal croissants, wedges, large bags, towels, and mosquito nets-these help limit the space and increase the sense of security. Aids for motor, sensory, and vibratory stimulation, stands for the hanging "basal world," and aids for creating basal worlds. The basal world is everything to provide patients for their own activity. Their purpose is to allow them to experience various sensory experiences, agency, and motivate them to be active. Materials for basal worlds should be heavy, cool, resonant, handy, and easy to grasp.
Being tested
physiotherapy, 2 x a week for 6 weeks, basal therapy, 2 x a week for 6 weeks, Standard therapy group
Keywords
Basal Stimulation Therapy, Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physiotherapy, 2 x a week for 6 weeksOther

    Only 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 weeksOther

    basal 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 groupOther

    Both groups will receive standard therapy based on best clinical practice principles for 12 weeks.

Study groups in NCT07769749
Study groupRoleWhat they receive
A - standard therapy + physiotherapyExperimentalA - standard therapy + physiotherapy, 2 x a week for 6 weeks, N= 6
Receives: Other: physiotherapy, 2 x a week for 6 weeks; Other: basal therapy, 2 x a week for 6 weeks; Other: Standard therapy group
B - standard therapy + basal therapyExperimentalB - standard therapy + basal therapy, 2 x a week for 6 weeks, N=6
Receives: Other: physiotherapy, 2 x a week for 6 weeks; Other: basal therapy, 2 x a week for 6 weeks; Other: Standard therapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  3. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (1)
  1. 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).

    Measured: From enrollment, at 6 weens and at the end of the study at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
After obtaining the patients' legal guardians/caregivers consent to participate in the study, the patients will be divided into two experimental groups of six participants (group 1 and 2). An AB/BA crossover experimental design will be conducted, where: 1. A - standard therapy + physiotherapy, 2 x a week for 6 weeks. 2. B - standard therapy + basal therapy, 2 x a week for 6 weeks. Patients in group 1 will receive AB therapy, Patients in group 2 will receive BA therapy. The total duration of the study will be 12 weeks and include 12 patients.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07769749
Sponsor's protocol ID
Resolution no. 01-IX/2025
Status last verified
Aug 2026
First submitted
26 Jul 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study protocol and individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.

Questions about this trial

What is this clinical trial studying?

A study testing physiotherapy, 2 x a week for 6 weeks, basal therapy, 2 x a week for 6 weeks and Standard therapy group in people with SCHIZOPHRENIA 1 (Disorder), run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alicja Kosmalska, MD (032 43 28 217, alicja.kosmalska@psychiatria.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measures - GCS (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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