ClinicalTrials.gg
Not yet recruitingNCT07758478Updated Aug 11, 2026

Montessori-Based Interventions for Older Adults

An interventional study of Montessori in Activities, Daily Living and Cognitive Function, sponsored by Gazi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Motor Activity by Gazi University — 8 open to participants now, 8 under way, none of them phase 3. Motor Activity · Gazi University.

Planned enrollment
6th of 29
60 · median 40
Started
2026
the only one that year
No phase
29 of 56
7 open now
Registered
55th of 56
by date

Among the 56 studies in Motor Activity by Gazi University, this one is the 6th largest by planned enrollment of the 29 interventional ones, is the only one that started in 2026, is one of 29 with no phase, and was the 55th registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phasethis study29 · 7 open
Observational27 · 1 open

By the year they started

First in 2012; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 40 across the 29 interventional studies, 50 across the 27 observational. Of the 41 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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 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.

03

Conditions studied

  • Activities, Daily Living
  • Cognitive Function

Browse trials for

Keywords

  • Older People
  • Montessori
  • Cognitive
  • Activities, Daily Living
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Montessori

    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.

    Other: Montessori

  • No intervention
    Control

    Throughout the study, the control group will continue with routine nursing home activities.

Interventions

  • OtherMontessori

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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".

    Time frame: Baseline, Week 8

07

Study locations

1 site
  • Kastamonu
    Kastamonu, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Oct 2026, 1 month later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 1 month is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 11, 2026
StartEst.
Aug 24, 2026
Primary completionEst.
Oct 19, 2026
CompletionEst.
Oct 19, 2026
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07758478
Lead sponsor
Gazi University
Responsible party
Naile Bilgili (Prof. Dr., Gazi University) — Principal investigator
First posted
Aug 11, 2026
Start date
Aug 24, 2026 (estimated)
Primary completion
Oct 19, 2026 (estimated)
Completion
Oct 19, 2026 (estimated)
Last update
Aug 11, 2026

Study contacts

Semanur Çelik Demiryürek, Master of Science
Contact
semanur.demiryurek@gazi.edu.tr
+905394004408

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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