- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06417073
Effects of Task-Oriented Station Training on Cognitive Levels and Hand Functions in Geriatric Residents of Nursing Homes
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
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Çankırı, Turkey, 06060
- Çankırı Karatekin University
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Çankırı, Turkey
- Çakü
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
**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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Face-to-Face Interventions
|
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.
|
Experimental: Tele-Rehabilitation
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This intervention utilizes video-conferencing technology to deliver task-oriented training to elderly nursing home residents, focusing on cognitive and hand function improvements.
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Experimental: Home-Based Training
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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),
|
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.
|
Baseline (start of intervention), Post-intervention (immediately after the 2-week intervention),
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Hand Function Using the Nine-Hole Peg Test
Time Frame: Baseline and Post-intervention (immediately after the 2-week intervention).
|
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.
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Baseline and Post-intervention (immediately after the 2-week intervention).
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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).
|
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.
|
Baseline and Post-intervention (immediately after the 2-week intervention).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- d897232bb89442f7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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