Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

The Effectiveness of Cognitive Rehabilitation Intervention With the Telerehabilitation Method for Amnestic Mild Cognitive Impairment: A Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05664984
• Other study ID #: 20/513
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2022
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Mild Cognitive Impairment

Intervention

Behavioral:
• 1-face-to-face
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.
• 2-tele rehabilitation
2-tele rehabilitation

Locations

Country	Name	City	State
Turkey	University of Health Sciences Türkiye	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before the first session
Primary	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.	after the 12-week intervention program