Cognitive DeclineNCT06417073
Effects of Task-Oriented Station Training on Cognitive Levels and Hand Functions in Geriatric Residents of Nursing Homes
A study testing Face-To-Face Task-orianted Training, Tele-Rehabilitation Task-orianted Training and Home-based Task-orianted Training in people with Cognitive Decline and Motor Function Disorders, run by Çankırı Karatekin University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cognitive Decline, Motor Function Disorders, Geriatric Health
- What is being tested?
- Face-To-Face Task-orianted Training, Tele-Rehabilitation Task-orianted Training and Home-based Task-orianted Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Çankırı Karatekin University
Çankırı, 06060
Çakü
Çankırı
About this study
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
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.
- Being tested
- Face-To-Face Task-orianted Training, Tele-Rehabilitation Task-orianted Training, Home-based Task-orianted Training
- Keywords
- Task-Oriented Station Training, Cognitive Function, Hand Function, Tele-Rehabilitation, Face-to-Face Intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-To-Face Task-orianted TrainingBehavioural
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.
Tele-Rehabilitation Task-orianted TrainingBehavioural
This intervention utilizes video-conferencing technology to deliver task-oriented training to elderly nursing home residents, focusing on cognitive and hand function improvements.
Home-based Task-orianted TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Interventions | Experimental | Not described Receives: Behavioral: Face-To-Face Task-orianted Training |
| Tele-Rehabilitation | Experimental | Not described Receives: Behavioral: Tele-Rehabilitation Task-orianted Training |
| Home-Based Training | Experimental | Not described Receives: Behavioral: Home-based Task-orianted Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Using the Mini-Mental State Examination (MMSE)
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.
Measured: Baseline (start of intervention), Post-intervention (immediately after the 2-week intervention),
Secondary outcomes (2)
Improvement in Hand Function Using the Nine-Hole Peg Test
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.
Measured: Baseline and Post-intervention (immediately after the 2-week intervention).
Quality of Life Changes Measured by the Short Form Health Survey (SF-36)
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.
Measured: Baseline and Post-intervention (immediately after the 2-week intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 Jan 2024
- Primary completion15 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Türkmen, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417073
- Sponsor's protocol ID
- d897232bb89442f7
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06417073
- Acronym / sponsor ID
- d897232bb89442f7
- Keywords
- Task-Oriented Station Training, Cognitive Function, Hand Function, Tele-Rehabilitation, Face-to-Face Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Interventions | Experimental | Behavioral: Face-To-Face Task-orianted Training |
| Tele-Rehabilitation | Experimental | Behavioral: Tele-Rehabilitation Task-orianted Training |
| Home-Based Training | Experimental | Behavioral: Home-based Task-orianted Training |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-To-Face Task-orianted TrainingIn 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. | Behavioural | Face-to-Face Interventions |
| Tele-Rehabilitation Task-orianted TrainingThis intervention utilizes video-conferencing technology to deliver task-oriented training to elderly nursing home residents, focusing on cognitive and hand function improvements. | Behavioural | Tele-Rehabilitation |
| Home-based Task-orianted TrainingHome-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. | Behavioural | Home-Based Training |
Primary outcome
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.
2 secondary outcomes
Improvement in Hand Function Using the Nine-Hole Peg Test
Time frame: Baseline and Post-intervention (immediately after the 2-week intervention).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-To-Face Task-orianted Training, Tele-Rehabilitation Task-orianted Training and Home-based Task-orianted Training in people with Cognitive Decline and Motor Function Disorders, run by Çankırı Karatekin University at 2 sites 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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),). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.