Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT05664984
Collaborator
(none)
68
1
2
17
4

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 1-face-to-face
  • Behavioral: 2-tele rehabilitation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
single blind randomized controlled trialsingle blind randomized controlled trial
Masking:
Single (Outcomes Assessor)
Masking Description:
The investigator who evaluated the cases was blinded from the study.
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Cognitive Rehabilitation Intervention With the Telerehabilitation Method for Amnestic Mild Cognitive Impairment: A Feasibility Randomized Controlled Trial
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Aug 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G) [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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Health Sciences Türkiye Ankara Turkey

    Sponsors and Collaborators

    • Saglik Bilimleri Universitesi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Berkan Torpil, PhD, Associate professor, Saglik Bilimleri Universitesi
    ClinicalTrials.gov Identifier:
    NCT05664984
    Other Study ID Numbers:
    • 20/513
    First Posted:
    Dec 27, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 27, 2022