ClinicalTrials.gg
Not yet recruitingNCT07769749Updated Aug 18, 2026

Basal Stimulation Therapy in Adults With Schizophrenia Requiring Institutional Care

An interventional study of physiotherapy, 2 x a week for 6 weeks and basal therapy, 2 x a week for 6 weeks in SCHIZOPHRENIA 1 (Disorder), sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice. Not yet recruiting at 2 sites in Poland. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

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:

    1. 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.
    2. 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).
  3. 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.

5. 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.

6. 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.

7. 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.

02

Conditions studied

  • SCHIZOPHRENIA 1 (Disorder)

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Keywords

  • Basal Stimulation Therapy
  • Schizophrenia
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 12 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

The Jerzy Kukuczka Academy of Physical Education in Katowice is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    A - standard therapy + physiotherapy

    A - standard therapy + physiotherapy, 2 x a week for 6 weeks, N= 6

    Other: physiotherapy, 2 x a week for 6 weeks · Other: basal therapy, 2 x a week for 6 weeks · Other: Standard therapy group

  • Experimental
    B - standard therapy + basal therapy

    B - standard therapy + basal therapy, 2 x a week for 6 weeks, N=6

    Other: physiotherapy, 2 x a week for 6 weeks · Other: basal therapy, 2 x a week for 6 weeks · Other: Standard therapy group

Interventions

  • Otherphysiotherapy, 2 x a week for 6 weeks

    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.

  • Otherbasal therapy, 2 x a week for 6 weeks

    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.

  • OtherStandard therapy group

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

Secondary outcomes

  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).

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

Other outcomes

  1. 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).

    Time frame: From enrollment to the end of treatment at 12 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

2 sites
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The study protocol and individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.

Supporting information: Study protocol, Informed consent form

Time frame: Individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.

Access criteria: Individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07769749
Lead sponsor
The Jerzy Kukuczka Academy of Physical Education in Katowice
Collaborators
Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
Responsible party
Laura Piejko (Pr, PhD. Head of Clinical Unit of Physiotherapy in Psychiatry, Department of Clinical Physiotherapy at The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, The Jerzy Kukuczka Academy of Physical Education in Katowice) — Principal investigator
First posted
Aug 18, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Alicja Kosmalska, MD
Contact
alicja.kosmalska@psychiatria.com
032 43 28 217
Laura Piejko, PT, PhD
Contact
laura.piejko@psychiatria.com
032 43 28 185
Laura Piejko, PT, PhD
principal investigator · The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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