Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

December 16, 2022 updated by: Berkan Torpil, PhD, Saglik Bilimleri Universitesi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • University of Health Sciences Türkiye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 1-face-to-face group
Cognitive rehabilitation intervention was given face-to-face.
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.
Other Names:
  • Cognitive rehabilitation
Experimental: 2-tele rehabilitation group
Cognitive rehabilitation intervention was given tele-rehabilitation method.
Behavioral: 2-tele rehabilitation
2-tele rehabilitation
Other Names:
  • Cognitive rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
Time Frame: before the first session
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
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
Time Frame: 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.
after the 12-week intervention program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Estimate)

December 26, 2022

Study Record Updates

Last Update Posted (Estimate)

December 26, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/513

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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