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Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
1-face-to-face
2-tele rehabilitation
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 65 and 75 years Diagnosed with amnestic-MCI by medical doctors Access to technological equipment; and Ability to understand and follow verbal instructions. Exclusion Criteria: Secondary chronic disease that may affect cognitive functioning; Auditory and visual problems that may affect rehabilitation implementation and communication; and Attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period.

Sites / Locations

  • University of Health Sciences Türkiye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1-face-to-face group

2-tele rehabilitation group

Arm Description

Cognitive rehabilitation intervention was given face-to-face.

Cognitive rehabilitation intervention was given tele-rehabilitation method.

Outcomes

Primary Outcome Measures

The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
The LOTCA-G, which was created to evaluate cognitive functions in the elderly. This test evaluates 8 cognitive domains with 24 items: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, thinking operations, attention/concentration, and memory. The items in each subtest are evaluated on an ordered scale from 1 to 4 (excluding the orientation items scored from 1 to 8). A higher test score indicates better cognitive performance. The LOTCA-G can differentiate healthy older adults from those with dementia and MCI. It is sensitive to dementia levels and identifies changes over time. The LOTCA-G was used to evaluate the effectiveness of cognitive rehabilitation intervention both face-to-face and with tele-rehabilitation method. It was planned to evaluate the effectiveness of the intervention, which consisted of a total of 24 sessions of 12 weeks, by making a total of two evaluations before and after the treatment.
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
The LOTCA-G, which was created to evaluate cognitive functions in the elderly. This test evaluates 8 cognitive domains with 24 items: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, thinking operations, attention/concentration, and memory. The items in each subtest are evaluated on an ordered scale from 1 to 4 (excluding the orientation items scored from 1 to 8). A higher test score indicates better cognitive performance. The LOTCA-G can differentiate healthy older adults from those with dementia and MCI. It is sensitive to dementia levels and identifies changes over time. The LOTCA-G was used to evaluate the effectiveness of cognitive rehabilitation intervention both face-to-face and with tele-rehabilitation method. It was planned to evaluate the effectiveness of the intervention, which consisted of a total of 24 sessions of 12 weeks, by making a total of two evaluations before and after the treatment.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
December 16, 2022
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05664984
Brief Title
Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment
Official Title
The Effectiveness of Cognitive Rehabilitation Intervention With the Telerehabilitation Method for Amnestic Mild Cognitive Impairment: A Feasibility Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Different cognitive rehabilitation intervention methods have been developed for the treatment of cognitive dysfunctions seen in mild cognitive impairment (MCI). The aim of this study was to examine the effectiveness of cognitive rehabilitation intervention applied with the telerehabilitation method in elderly patients with amnestic-MCI. Participants included in the study according to inclusion and exclusion criteria were randomly assigned to the telerehabilitation and face-to-face groups. A 12-week cognitive rehabilitation intervention was applied to both groups. Pre- and post-intervention cognitive skills of the participants were evaluated using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G).
Detailed Description
A single-blinded, feasibility randomized controlled trial (RCT) investigated changes in the cognitive functions of older adults with amnestic-MCI after CR interventions applied face-to-face and with telerehabilitation. The study was designed according to the CONSORT statement. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study. The demographic characteristics of the participants were recorded, including age, sex, education level, and marital status. All participants underwent a cognitive function assessment using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric twice, once before the intervention and again after the 12-week intervention. All participants were assessed in occupational therapy clinical practice units. Participants were randomized to either the Face-to-Face group (FF) or the Tele-rehabilitation group (TR) using a computer-generated randomization technique. After the randomization, cognitive rehabilitation intervention for both methods consist of 45-minute twice a week for 12 weeks. All participants received the intervention individually.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blind randomized controlled trial
Masking
Outcomes Assessor
Masking Description
The investigator who evaluated the cases was blinded from the study.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-face-to-face group
Arm Type
Experimental
Arm Description
Cognitive rehabilitation intervention was given face-to-face.
Arm Title
2-tele rehabilitation group
Arm Type
Experimental
Arm Description
Cognitive rehabilitation intervention was given tele-rehabilitation method.
Intervention Type
Behavioral
Intervention Name(s)
1-face-to-face
Other Intervention Name(s)
Cognitive rehabilitation
Intervention Description
The cognitive rehabilitation intervention consists of 45-minute sessions, 2 days a week for 12 weeks. The same rehabilitation intervention program was applied to both groups by face-to-face or tele-rehabilitation method. The main purpose of the study is to see the effectiveness of cognitive rehabilitation intervention in the elderly with amnestic mild cognitive impairment and to compare the two methods.
Intervention Type
Behavioral
Intervention Name(s)
2-tele rehabilitation
Other Intervention Name(s)
Cognitive rehabilitation
Intervention Description
2-tele rehabilitation
Primary Outcome Measure Information:
Title
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
Description
The LOTCA-G, which was created to evaluate cognitive functions in the elderly. This test evaluates 8 cognitive domains with 24 items: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, thinking operations, attention/concentration, and memory. The items in each subtest are evaluated on an ordered scale from 1 to 4 (excluding the orientation items scored from 1 to 8). A higher test score indicates better cognitive performance. The LOTCA-G can differentiate healthy older adults from those with dementia and MCI. It is sensitive to dementia levels and identifies changes over time. The LOTCA-G was used to evaluate the effectiveness of cognitive rehabilitation intervention both face-to-face and with tele-rehabilitation method. It was planned to evaluate the effectiveness of the intervention, which consisted of a total of 24 sessions of 12 weeks, by making a total of two evaluations before and after the treatment.
Time Frame
before the first session
Title
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
Description
The LOTCA-G, which was created to evaluate cognitive functions in the elderly. This test evaluates 8 cognitive domains with 24 items: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, thinking operations, attention/concentration, and memory. The items in each subtest are evaluated on an ordered scale from 1 to 4 (excluding the orientation items scored from 1 to 8). A higher test score indicates better cognitive performance. The LOTCA-G can differentiate healthy older adults from those with dementia and MCI. It is sensitive to dementia levels and identifies changes over time. The LOTCA-G was used to evaluate the effectiveness of cognitive rehabilitation intervention both face-to-face and with tele-rehabilitation method. It was planned to evaluate the effectiveness of the intervention, which consisted of a total of 24 sessions of 12 weeks, by making a total of two evaluations before and after the treatment.
Time Frame
after the 12-week intervention program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 65 and 75 years Diagnosed with amnestic-MCI by medical doctors Access to technological equipment; and Ability to understand and follow verbal instructions. Exclusion Criteria: Secondary chronic disease that may affect cognitive functioning; Auditory and visual problems that may affect rehabilitation implementation and communication; and Attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period.
Facility Information:
Facility Name
University of Health Sciences Türkiye
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

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