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Activities, Daily LivingNCT07758478

Montessori-Based Interventions for Older Adults

A study testing Montessori in people with Activities, Daily Living and Cognitive Function, run by Gazi University at 1 site in Turkey (Türkiye).

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 this study is to evaluate the effect of Montessori-based interventions on cognitive function and activities of daily living in older adults. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Activities, Daily Living, Cognitive Function
What is being tested?
Montessori
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Aug 2026to 19 Oct 2026
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Being 65 years of age or older
  • Having a Mini-Mental State Examination (MMSE) score of 18 or higher
  • Voluntarily agreeing to participate in the study

Who cannot join

  • Having a history of severe orthopedic or neurological disorders (e.g., stroke, Parkinson's disease, advanced osteoporosis)
  • Having severe sensory impairments (e.g., advanced vision or hearing loss)
  • Having severe physical activity restrictions due to cardiovascular diseases

Trial locations and contacts

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

Semanur Çelik Demiryürek, Master of Science contact

+905394004408

semanur.demiryurek@gazi.edu.tr

Turkey (Türkiye)1 site
  • Kastamonu

    Kastamonu

    Semanur Çelik Demiryürek, MSc, +905394004408, semanur.demiryurek@gazi.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Montessori-Based Interventions on Cognitive Function and Activities of Daily Living in Older Adults: Randomized Controlled Trial

The aim of this study is to evaluate the effect of Montessori-based interventions on cognitive function and activities of daily living in older adults.

Read the detailed description

The globally increasing life expectancy is leading to a rapid rise in the number of older adults. According to 2024 data from the United Nations, individuals aged 65 and older constitute 10.2% of the global population (United Nations, 2024). Similarly, according to the Turkish Statistical Institute (TÜİK) data, the proportion of the population aged 65 and over, which was 9.1% of the total population in 2019, increased to 10.6% in 2024 (TÜİK, 2024). These demographic shifts necessitate a more in-depth examination of the physical and mental health of older adults. Particularly during the aging process, the losses accompanying physical changes, the inability to fulfill independent roles, and cognitive impairments have emerged as significant public health issues within the scope of tertiary healthcare services in recent years (Latino \& Tafuri, 2024; Lisko et al., 2021).

Certain common characteristics associated with aging, such as alterations in perception, decreased cellular regeneration, prolonged physical and mental reaction times, and the loss of former physical strength, lead to changes in cognitive processes (Kim et al., 2015). During this process, a decline in productive capacity, weakened interest in environmental stimuli, delays in adapting to new situations, and a slowdown in cognitive functions such as memory, attention, and thinking are observed (Lisko et al., 2021). Cognitive decline is evaluated within a spectrum ranging from simple forgetfulness to dementia, causing various difficulties in individuals' social, occupational, and community lives. The onset of cognitive changes leads to a decrease in the level of independence in activities of daily living; this situation causes older adults to transition from an independent life to a semi-dependent or fully dependent one (Hewston et al., 2021). These changes pose even greater challenges, particularly for older adults residing in institutional care, which negatively affects their cognitive functioning and activities of daily living (Biazus-Sehn et al., 2020; Hewston et al., 2021).

Stimuli and activities customized according to the cognitive levels or personal experiences of older adults can significantly reduce agitation and problem behaviors associated with dementia (Feng et al., 2018; Van Mierlo et al., 2010). A study conducted by Kocaman et al. with older adults demonstrated that a regularly implemented exercise program has a positive effect on postural control, gait, and cognitive functions (Kocaman et al., 2020). Another study revealed that game-based physical activities provided significant improvements in the motor skills of older adults, and this effect was also reflected at the cognitive level (Karabulut, 2023). In a thesis study conducted by İnel Manav with older adults suffering from mild dementia, it was concluded that internet-based video group reminiscence therapy had a significant effect on the cognitive functional status of older adults with mild dementia (İnel Manav, 2018). In addition to these, visual and auditory interventions such as puzzles, chess, paper-and-pencil activities, dance, and music can also be beneficial for cognitive functions. In this context, one of the prominent approaches for older adults in recent years, particularly in dementia care, is Montessori-based interventions (Çınar et al., 2022; Mondini et al., 2016; Simon et al., 2020). Originally developed to support the cognitive and sensory development of children, the Montessori method has recently been adapted to preserve and support the remaining functional capacity of older adults living with dementia. This approach aims to increase engagement, reduce behavioral symptoms, and support the individual's quality of life by providing meaningful activities structured progressively in accordance with the individual's cognitive level (Camp, 2010; Feng et al., 2018).

Montessori-based interventions were first developed by Maria Montessori in 1907 for the education of children. This educational method was applied to equip children with cognitive, social, and functional skills by breaking tasks down into steps from simple to complex and from concrete to abstract. Thus, children were encouraged to step out of their comfort zones to develop their skills (Camp, 2010; Feng et al., 2018; Malone \& Camp, 2007; Sheppard, McArthur \& Hitzig, 2016). The initial steps towards applying Montessori-based interventions for individuals with dementia were taken by Dr. Cameron Camp in the 1990s (Camp, 2010). In older adults, Montessori-based interventions focus on the individual's strengths rather than their weaknesses, aiming to foster development through these strengths. This encourages the creation of personalized programs taking into account the individual's lifestyle, interests, likes, and dislikes (Brush, 2020; Rodrigues, 2023). Montessori-based interventions are founded on the principles of respect, dignity, autonomy, and equality, and are personalized according to the cognitive capacities of the individuals. In this approach, the use of familiar materials, the division of tasks into small, manageable steps, and the inclusion of repetitions progressing from simple to complex allow individuals to learn at their own pace and experience a sense of accomplishment. Furthermore, these interventions support engagement and independence by encouraging individuals to interact with their social and physical environments through purposeful and meaningful activities (Camp, 2010). In this context, Montessori-based interventions, rooted in person-centered care principles, offer an important theoretical foundation for supporting cognitive and functional capacity as well as activities of daily living. They aim to activate the individual's preserved implicit memory system through structured activities, environmental modifications, and guiding elements (Berkovic et al., 2024; Camp et al., 2018). Within this framework, to explain the effect of Montessori-based interventions, the cognitive decline processes that emerge with age and their reflections on activities of daily living must be evaluated together.

With advancing age, the problem of decline in cognitive functions due to neurodegeneration is frequently observed (Lv et al., 2025). In cognitive impairments, the explicit memory system is affected early on because its processes are dependent on the hippocampus. In contrast, procedural (implicit) learning and the repetition-based priming effect-which leads to an increase in the speed and accuracy of responses through the repeated presentation of stimuli-can operate independently of the hippocampus (Beaunieux et al., 2012; De Wit et al., 2022). This provides a theoretical basis for developing behavioral interventions targeting implicit memory to compensate for learning difficulties arising from hippocampal damage in cognitive impairments (De Wit et al., 2022). In this context, while Montessori activities support "explicit memory" through guiding and reminding elements in the individual's environment, they are structured to enable the use of the "implicit memory" system. This is achieved by reducing the need for language use and complex cognitive processing, dividing tasks into small and manageable steps, and supporting the individual's use of this preserved memory system through structured, repetitive practices and environmental cues (Camp, 2010; Giroux et al., 2010; Larson, 2010; Malone \& Camp, 2007; Mousavi et al., 2022). Additionally, these interventions incorporate an error control mechanism that allows the individual to evaluate their own success without needing external feedback. This error control process offers individuals the opportunity to experience a sense of achievement, generally leading to increased self-confidence and allowing them to participate in activities with a calmer and more engaged approach (Brenner \& Brenner, 2012; Rodrigues, 2023).

Loss of muscle strength, restricted mobility, and decline in sensory and cognitive functions that occur with age lead to a decrease in activities of daily living (ADLs) among older adults (Chang et al., 2025). Conversely, sensory-based and structured activities emerge as a fundamental approach that increases individuals' participation in activities when presented alongside individual guidance and a supportive environment. Such activities enhance motivation for participation by strengthening emotional expression and self-confidence; at the same time, they contribute to individuals maintaining their daily routines more independently in collaboration with their caregivers. Since ADL performance requires the coordination of motor, sensory, and cognitive processes, this holistic stimulation provided is considered a fundamental mechanism supporting functional capacity (Gambella et al., 2025; Liao et al., 2019; Sun et al., 2022). It has been reported that such interventions aimed at maintaining motor skills and flexibility increase independence in basic activities such as feeding, dressing, and personal care (Ljubič et al., 2023; Sun et al., 2022). Furthermore, a meta-analysis study demonstrated that sensory-based activities increased participation, thereby strengthening individuals' levels of emotional expression, self-confidence, and cooperation, indirectly improving ADL performance through this process (Sun et al., 2022). Based on these findings, it is considered that the integration of Montessori principles into geriatric care can support both the functional independence and cognitive performance of individuals through the cognitive, sensory, and psychomotor stimulation it provides. In this context, planning and implementing such non-pharmacological, independence-enhancing interventions to preserve the functional capacities of older adults and support their active aging directly align with the core professional responsibilities of public health nurses. Indeed, the primary roles of public health nursing include enhancing individuals' self-care capacities, guiding them in maintaining independent living skills, and creating adapted environments that promote health (Williams, 2021). In Montessori-based interventions, public health nurses are also expected to offer older adults the opportunity to utilize their own potential, supporting them cognitively, sensorially, and physically, thereby contributing to the goal of independence.

It has been demonstrated in the literature that Montessori-based interventions provide numerous benefits. Considering the participation of individuals with dementia in the process through a person-centered approach, it is emphasized that these interventions lead to positive changes, such as an increase in general quality of life and cognitive functions for both the individual with dementia and the caregiver (Booth et al., 2020; Brenner \& Brenner, 2012; Feng et al., 2018; Rodrigues, 2023; Sheppard, McArthur \& Hitzig, 2016). However, no study applying Montessori-based interventions to older adults has been found in our country. The aim of this study is to evaluate the effect of Montessori-based interventions, known as an evidence-based intervention method, on cognitive function and activities of daily living in older adults.

Being tested
Montessori
Keywords
Older People, Montessori, Cognitive, Activities, Daily Living
Medical subject headings
Motor Activity

What participants receive

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

  • MontessoriOther

    Prior to the study, participants will be provided with detailed information regarding the research, and written informed consent will be obtained from all volunteers. At baseline, initial data will be collected using a "Personal Information Form" and the "Barthel Index of Activities of Daily Living (ADL)". Subsequently, the experimental group will receive structured Montessori-based interventions tailored for nursing home residents. These application sessions will be conducted two days a week for a total duration of 8 weeks. Upon completion of the 8-week intervention period, post-test evaluations will be administered to measure the outcomes. This final assessment will include the re-administration of the "Barthel Index of ADL" to determine functional changes, alongside the "Standardized Mini-Mental State Examination (SMMSE)" or the "MMSE for the Uneducated", depending on the participant's educational level, to evaluate cognitive changes.

Study groups in NCT07758478
Study groupRoleWhat they receive
MontessoriExperimentalPrior to the study, participants will be provided with detailed information regarding the research, and written informed consent will be obtained from all volunteers. At baseline, initial data will be collected using a "Personal Information Form" and the "Barthel Index of Activities of Daily Living (ADL)". Subsequently, the experimental group will receive structured Montessori-based interventions tailored for nursing home residents. These application sessions will be conducted two days a week for a total duration of 8 weeks. Upon completion of the 8-week intervention period, post-test evaluations will be administered to measure the outcomes. This final assessment will include the re-administration of the "Barthel Index of ADL" to determine functional changes, alongside the "Standardized Mini-Mental State Examination (SMMSE)" or the "MMSE for the Uneducated", depending on the participant's educational level, to evaluate cognitive changes.
Receives: Other: Montessori
ControlNo interventionThroughout the study, the control group will continue with routine nursing home activities.

What is being measured

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

  1. Change from baseline in cognitive function, as measured by the Standardized Mini-Mental State Examination (SMMSE)

    This test consists of 11 items categorized under five main domains: orientation, registration, attention and calculation, recall, and language. The SMMSE is scored out of a maximum of 30 points, with one point awarded for each correct response. While a score of 23/24 is considered the cutoff point for dementia, SMMSE scores are further classified as 18-23 points indicating mild dementia, 10-17 points for moderate dementia, and 10 points or fewer representing severe dementia.

    Measured: Baseline, Week 8

  2. Change from baseline in activities of daily living, as measured by the Barthel Index of Activities of Daily Living (ADL)

    The scale, consisting of 10 sub-domains that include activities such as feeding, bathing, personal grooming, dressing, toilet use, transfers, mobility, and stair climbing, measures the patient's level of independence and is generally preferred for individuals with motor and sensory impairments. Scoring ranges from 0 to 100, where a score of 0 signifies total dependence and a score of 100 signifies complete independence. The scores obtained from the scale are interpreted in terms of performing activities of daily living (ADLs) as follows: 0-20 points indicate "total dependence"; 21-61 points indicate "severe dependence"; 62-90 points indicate "moderate dependence"; 91-99 points indicate "mild dependence"; and a score of 100 is interpreted as "completely independent".

    Measured: Baseline, Week 8

Timeline

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

  1. First posted11 Aug 2026
  2. Study start24 Aug 2026 (estimated)
  3. Primary completion19 Oct 2026 (estimated)
  4. Study completion19 Oct 2026 (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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study was designed as a randomized controlled experimental study with a pre-test/post-test design.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07758478
Sponsor's protocol ID
E-77082166-302.08.01-1337929
Status last verified
Jul 2026
First submitted
6 Aug 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun, X., Sun, Z., & Ma, H. (2022). Effect of Montessori method on the cognitive and behavioral intervention of senile dementia patients: A meta-analysis. Aging Communications, 4(2), 7.

  • Malone, M. L., & Camp, C. J. (2007). Montessori-based dementia programming®: Providing tools for engagement. Dementia, 6(1), 150-157.

  • Sheppard CL, McArthur C, Hitzig SL. A Systematic Review of Montessori-Based Activities for Persons With Dementia. J Am Med Dir Assoc. 2016 Feb;17(2):117-22. doi: 10.1016/j.jamda.2015.10.006. Epub 2015 Nov 14.

    PubMed 26589532
  • Feng, Y., van Reijmersdal, R., Yu, S., Rauterberg, M., Hu, J., & Barakova, E. (2018). Dynamorph: Montessori inspired design for seniors with dementia living in long-term care facilities. In Intelligent Technologies for Interactive Entertainment: 9th International Conference, INTETAIN 2017, Funchal, Portugal, June 20-22, 2017, Proceedings 9 (pp. 49-58). Springer International Publishing.

  • Camp CJ. Origins of Montessori Programming for Dementia. Nonpharmacol Ther Dement. 2010;1(2):163-174.

    PubMed 23515663

Questions about this trial

What is this clinical trial studying?

A study testing Montessori in people with Activities, Daily Living and Cognitive Function, run by Gazi University at 1 site in Turkey (Türkiye).

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. 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 11 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 1 site in Turkey (Türkiye). 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 Semanur Çelik Demiryürek, Master of Science (+905394004408, semanur.demiryurek@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in cognitive function, as measured by the Standardized Mini-Mental State Examination (SMMSE) (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07758478, which also lists 5 linked publications.

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 11 Aug 2026.

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