Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Cognitive Impairment
• Interventions: Behavioral: 2-tele rehabilitation; Behavioral: 1-face-to-face

• Registration Number: NCT05664984
• Lead Sponsor: Saglik Bilimleri Universitesi

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-08-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-16
• Last Update Submitted: 2022-12-16
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-tele rehabilitation group	2-tele rehabilitation	Cognitive rehabilitation intervention was given tele-rehabilitation method.
1-face-to-face group	1-face-to-face	Cognitive rehabilitation intervention was given face-to-face.

Primary Outcome Measures

Name	Time	Method
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)	after the 12-week intervention program	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.

Trial Locations

Locations (1)

University of Health Sciences Türkiye; 🇹🇷 Ankara, Turkey