## Protocol Section
### Identification Module
**NCT ID:** NCT06417073

**Brief Title:** Effects of Task-Oriented Station Training on Cognitive Levels and Hand Functions in Geriatric Residents of Nursing Homes

**Official Title:** Effects of Task-Oriented Station Training on Cognitive and Hand Functions in Nursing Home Elders: Comparing Tele-Rehabilitation, Face-to-Face, and Home-Based Interventions

#### Organization Study ID Info
**ID:** d897232bb89442f7
#### Organization
**Class:** OTHER
**Full Name:** Çankırı Karatekin University
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-15

**Type:** ACTUAL

#### Start Date
**Date:** 2024-01-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Çankırı Karatekin University

#### Responsible Party

**Investigator Affiliation:** Çankırı Karatekin University

**Investigator Full Name:** Ceyhun Türkmen

**Investigator Title:** Assoc. Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study explores the impact of task-oriented station training on the cognitive levels and hand functions of elderly residents in nursing homes. Utilizing methods like tele-rehabilitation, face-to-face sessions, and home-based programs, this research aims to determine the most effective approach for improving the cognitive and manual skills of this population. The hypothesis driving this study is that targeted task-oriented training can significantly improve the cognitive functions and hand dexterity of elderly individuals living in nursing homes, potentially enhancing their quality of life and independence. Participants receive different types of interventions-tele-rehabilitation, direct face-to-face training, and guided home programs-to evaluate which modality most effectively supports cognitive and hand function improvements. The study's design is randomized and assesses the outcomes through various established psychological and physical tests. With an aging global population, such strategies are crucial for maintaining the independence and quality of life of our elderly, potentially reducing the need for intensive care solutions and allowing for longer periods of self-sufficiency and well-being. This summary presents the study in a straightforward manner, explaining the purpose, hypothesis, methods, and significance of the research to make it accessible to non-specialist readers.

### Conditions Module

**Conditions:**

- Cognitive Decline

- Motor Function Disorders

- Geriatric Health

**Keywords:**

- Task-Oriented Station Training

- Cognitive Function

- Hand Function

- Tele-Rehabilitation

- Face-to-Face Intervention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Face-To-Face Task-orianted Training

**Label:** Face-to-Face Interventions

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Tele-Rehabilitation Task-orianted Training

**Label:** Tele-Rehabilitation

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Behavioral: Home-based Task-orianted Training

**Label:** Home-Based Training

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Face-to-Face Interventions

**Description:** In this study, face-to-face task-oriented station training is provided by trained occupational therapists to elderly nursing home residents. Each session involves structured activities that simulate real-world challenges designed to improve cognitive and hand functions. These include exercises to enhance fine motor skills, hand strength, coordination, and cognitive tasks such as problem-solving and memory exercises.

**Name:** Face-To-Face Task-orianted Training

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Tele-Rehabilitation

**Description:** This intervention utilizes video-conferencing technology to deliver task-oriented training to elderly nursing home residents, focusing on cognitive and hand function improvements.

**Name:** Tele-Rehabilitation Task-orianted Training

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Home-Based Training

**Description:** Home-Based Task-Oriented Training Intervention Description:

This home-based intervention involves a series of task-oriented activities specifically designed to improve cognitive and hand functions for elderly residents in nursing homes. Participants carry out prescribed activities independently, based on detailed guides provided by occupational therapists. The activities are tailored to stimulate cognitive processes and enhance fine motor skills, including tasks like sorting, assembling, and manipulative exercises that replicate daily challenges. Each participant follows a structured program of daily 45-minute sessions for two weeks, with periodic remote check-ins by therapists to assess progress and adjust the difficulty of tasks as needed. This format allows participants to engage in rehabilitation at their own pace, within the comfort of their own living spaces, fostering greater autonomy and adherence to the intervention.

**Name:** Home-based Task-orianted Training

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The Mini-Mental State Examination (MMSE) is a widely used tool for assessing cognitive function, which measures various aspects of cognitive abilities including orientation to time and place, immediate recall, short-term memory, language use, comprehension, and basic motor skills. The score ranges from 0 to 30, with higher scores indicating better cognitive function. This test will be used to quantify changes in cognitive levels of participants after undergoing task-oriented station training.

**Measure:** Change in Cognitive Function Using the Mini-Mental State Examination (MMSE)

**Time Frame:** Baseline (start of intervention), Post-intervention (immediately after the 2-week intervention),

#### Secondary Outcomes

**Description:** The Nine-Hole Peg Test measures dexterity and hand function. Participants are timed on how quickly they can place and then remove nine pegs into a pegboard with one hand. This test is used to evaluate fine motor skills improvement, particularly the ability to coordinate visually guided fine movements.

**Measure:** Improvement in Hand Function Using the Nine-Hole Peg Test

**Time Frame:** Baseline and Post-intervention (immediately after the 2-week intervention).

**Description:** The SF-36 is a survey used to assess quality of life across eight domains: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). This measure will evaluate the impact of the intervention on overall well-being and life satisfaction.

**Measure:** Quality of Life Changes Measured by the Short Form Health Survey (SF-36)

**Time Frame:** Baseline and Post-intervention (immediately after the 2-week intervention).

### Eligibility Module

**Eligibility Criteria:** \*\*Inclusion Criteria:\*\*

* Age 65 years and older.
* Residency in a nursing home.
* Able to provide informed consent, either directly or through a legal guardian.
* Sufficient cognitive function to participate in the intervention, as indicated by a Mini-Mental State Examination (MMSE) score of 18 or higher.
* Physically able to participate in task-oriented activities, with or without assistive devices.
* Stable medical condition, with no hospitalizations due to acute illness in the last three months prior to the study commencement.

\*\*Exclusion Criteria:\*\*

* Diagnosed with severe dementia or any cognitive impairment severe enough as per the healthcare provider to interfere with participation in the study.
* Any medical condition that significantly limits physical activity or requires intensive medical care during the study period, such as unstable cardiovascular disease, severe osteoarthritis, or recent fractures.
* Participation in any other experimental rehabilitation or drug trials concurrently.
* Severe sensory deficits that would prevent participation in the tasks (e.g., severe vision or hearing loss not correctable with aids).
* Life expectancy less than 6 months as estimated by a physician.
* Significant psychiatric disorders that might impair the ability to comply with study protocols.

**Maximum Age:** 85 Years

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Çankırı

**Country:** Turkey

**Facility:** Çankırı Karatekin University

**Zip:** 06060

**Location 2:**

**City:** Çankırı

**Country:** Turkey

**Facility:** Çakü

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003072

- Term: Cognition Disorders

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: HIGH

- As Found: Cognitive Decline

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M6301

- Name: Cognition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000060825

- Term: Cognitive Dysfunction

### Misc Info Module

- Version Holder: 2024-05-31
