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Completed
NCT05706792
Effectiveness of the Nordic Sensi Chair in the Treatment of Dementia Behavioral Disorders (NSC-DEMEN)
Conditions: Dementia
Sex: All
Phase: NA
Enrollment: 88
Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Location: Spain
Summary
The main objective of this study is to evaluate the effectiveness of the Nordic Sensi® Chair (NSC) in the management of behavioral symptoms of dementia (BPSD) in real clinical practice in people with dementia admitted to nursing homes.
The secondary objective of the present study is to assess its benefits on the performance of the daily work activities of care staff.Although over time the BPSD have been treated predominantly with pharmacological measures, there is now sufficient scientific evidence to support the use of non-pharmacological therapies (NPT) for their management.Within this context, only a few studies have evaluated the use of rocking chairs for people with dementia.
Modern rocking chairs may be suitable for long-term care because rocking, a rhythmically repeated movement, can contribute to psychosocial wellbeing .In this regard, it is a focus of attention to consider the therapeutic role of the Nordic Sensi® Chair in the treatment of BPSD based on its ability to offer patients a sensory experience that brings the benefits of music therapy, therapeutic tactile stimulation, vestibular stimulation, and relaxation in an integrated way, especially those in nursing homes.
The NSC is an electrically operated rocking chair with built-in MusiCure music.
It is equipped with an integrated audio system with music recording.
The NSC has three different programs: Relax for deep relaxation, Refresh for recovery and Comfort for gentle relaxation.
In addition to musical programming, the NSC provides predefined tactile stimulation and rocking motion, for a relaxing multi-sensory experience.In this study, the 20 minutes NSC deep relaxation program (Relax Program) will be used.Participants are randomly assigned to two groups of equal size: a treatment group that receives three times a week one session per day of 20 minutes in the Relax for deep relaxation program of the NSC and a control group that does not participate in the activity mentioned for the treatment group, but receives, at the same time and duration, the care and activities that are part of the daily routines.Although cognitive and functional symptoms have been the hallmarks of dementia, in recent years behavioral and psychological symptoms of dementia (BPSD) have become increasingly important.
In all cases, BPSD is always one of the most important challenges that both the patient and their caregivers will face throughout the course of the disease.
Eligibility Criteria
Inclusion Criteria:Men and women with a diagnosis of dementia according to the criteria of the eleventh edition of the International Classification of Diseases of the World Health Organization (ICD-11).The patients will be clinically defined in stages 5 to 7 of the Reisberg Global Deterioration Scale (GDS).All selected patients should have data on physical examination, neurological and psychiatric examination, as well as neuropsychological evaluation in their clinical history.Written informed consent signed by the patient or his/her legal representativeExclusion Criteria:Presence of focal neurological signs.Presence of focal vascular signs such as infarcts, microhemorrhages, hematomas, strokes, normal pressure hydrocephalus.Significant neurological history, such as brain trauma, brain tumors....Patients with epilepsy or inflammatory brain disease.Severe systemic diseases such as hypothyroidism or chronic renal failure.Substance abuse.Absence of a reliable informant.Absence of a complete medical history to assess study variables.
Source: ClinicalTrials.gov (NCT05706792). StuddyBuddy aggregates publicly available trial information.
