Basal Stimulation Therapy in Adults With Schizophrenia Requiring Institutional Care

NCT07769749 | Not Yet Recruiting

• 1 other identifier: Resolution no. 01-IX/2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

Basal Stimulation Therapy; Schizophrenia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Secondary Outcome Measure - EEG

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

Other Outcomes (2)

• Barthel scale

  From enrollment to the end of treatment at 12 weeks

• Emotional state observation

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

A - standard therapy + physiotherapy

EXPERIMENTAL

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

B - standard therapy + basal therapy

EXPERIMENTAL

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

physiotherapy, 2 x a week for 6 weeks OTHER

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.

A - standard therapy + physiotherapy; B - standard therapy + basal therapy

basal therapy, 2 x a week for 6 weeks OTHER

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.

A - standard therapy + physiotherapy; B - standard therapy + basal therapy

Standard therapy group OTHER

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

A - standard therapy + physiotherapy; B - standard therapy + basal therapy

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland: collaborator
• The Jerzy Kukuczka Academy of Physical Education in Katowice: lead

Study Sites (2)

Jerzy Kukuczka Academy of Physical Education in Katowice, Poland

Katowice, Silesian Voivodeship, 40-065, Poland

Location

Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland

Rybnik, Silesian Voivodeship, 44-200, Poland

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Laura Piejko, PT, PhD

  The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicja Kosmalska, MD

CONTACT

032 43 28 217; alicja.kosmalska@psychiatria.com

Laura Piejko, PT, PhD

CONTACT

032 43 28 185; laura.piejko@psychiatria.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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/principal investigator, who will not have direct contact with patients before group allocation. Group allocation will be performed using block randomization method.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

PL (2)