Clinical trial NCT05664984: Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment
Official title: The Effectiveness of Cognitive Rehabilitation Intervention With the Telerehabilitation Method for Amnestic Mild Cognitive Impairment: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Impairment
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blind randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
timeFrame: before the first session
measure: The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
timeFrame: after the 12-week intervention program
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Türkiye
Study officials:
References: