Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

NCT ID: NCT05664984

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single blind randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The investigator who evaluated the cases was blinded from the study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1-face-to-face group

Cognitive rehabilitation intervention was given face-to-face.

Group Type EXPERIMENTAL

1-face-to-face

Intervention Type BEHAVIORAL

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 group

Cognitive rehabilitation intervention was given tele-rehabilitation method.

Group Type EXPERIMENTAL

2-tele rehabilitation

Intervention Type BEHAVIORAL

2-tele rehabilitation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

2-tele rehabilitation

2-tele rehabilitation

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cognitive rehabilitation Cognitive rehabilitation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Berkan Torpil, PhD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Health Sciences Türkiye

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Torpil B, Pekcetin E, Pekcetin S. The effectiveness of cognitive rehabilitation intervention with the telerehabilitation method for amnestic mild cognitive impairment: A feasibility randomized controlled trial. J Telemed Telecare. 2025 Apr;31(3):320-327. doi: 10.1177/1357633X231189541. Epub 2023 Aug 3.

Reference Type DERIVED
PMID: 37537894 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20/513

Identifier Type: -

Identifier Source: org_study_id