Basal Stimulation Therapy in Adults With Schizophrenia Requiring Institutional Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: SCHIZOPHRENIA 1 (Disorder)
• Intervention / Treatment: Other: physiotherapy, 2 x a week for 6 weeks; Other: basal therapy, 2 x a week for 6 weeks; Other: Standard therapy group

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicja Kosmalska, MD; Phone Number: 032 43 28 217; Email: alicja.kosmalska@psychiatria.com
• Study Contact Backup: Name: Laura Piejko, PT, PhD; Phone Number: 032 43 28 185; Email: laura.piejko@psychiatria.com

Study Locations

• Poland
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-065
      • Jerzy Kukuczka Academy of Physical Education in Katowice, Poland
      • Contact: Laura Piejko, PT, PhD; Phone Number: 32 207 51 10; Email: l.piejko@awf.katowice.pl
      • Principal Investigator: Laura Piejko, PT, PhD
      • Principal Investigator: Alicja Kosmalska, MD
    • Rybnik, Silesian Voivodeship, Poland, 44-200
      • Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
      • Contact: Alicja Kosmalska, MD; Phone Number: 032 43 28 217; Email: alicja.kosmalska@psychiatria.com
      • Contact: Laura Piejko, PT, PhD; Phone Number: 032 43 28 185; Email: laura.piejko@psychiatria.com
      • Principal Investigator: Laura Piejko, PT, PhD
      • Principal Investigator: Alicja Kosmalska, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other: basal 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: preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems,; careful observation and appropriate care of the patient,; grading of stimuli and their appropriate stimulation,; recording the therapist's comments on the therapy card.; Other: Standard therapy group; Both groups will receive standard therapy based on best clinical practice principles for 12 weeks.
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; 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.; Other: basal 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: preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems,; careful observation and appropriate care of the patient,; grading of stimuli and their appropriate stimulation,; recording the therapist's comments on the therapy card.; Other: Standard therapy group; Both groups will receive standard therapy based on best clinical practice principles for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 12 weeks
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.	From enrollment to the end of treatment at 12 weeks
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.	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment, at 6 weens and at the end of the study at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 12 weeks
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.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
• Collaborators: Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
• Investigators: Principal Investigator: Laura Piejko, PT, PhD, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 26, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 18, 2026

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; Basal Stimulation Therapy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: Resolution no. 01-IX/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol and individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.
• IPD Sharing Time Frame: Individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.
• IPD Sharing Access Criteria: Individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No