Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05341804
Brief Summary:
After developing and pilot testing the training program, including the CogBals software, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG\&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Detailed Description:
Background: Individuals with schizophrenia often experience premature aging and accelerated aging, which increases the challenge of care and recovery. Improvement on balance and implementation of prevention from and deceleration of the disability process is of the critical issues in psychiatric rehabilitation. Unfortunately, evidence- based effective programs are limited. Recently, a novel balance training program through cognitive and balance dual task training has shown better outcomes in the elderly and other clinical populations. Yet, the dual task balance training has not been examined for schizophrenia. This dual task balance training with the Internet of Thing techniques is a novel and important program for middle-aged and older individuals with schizophrenia. Further study is needed to develop the training program and to examine the effectiveness.
Purposes: (1) To develop a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software (CogBals software) (1st year); (2) to pilot the feasibility of the balance training program for the middle-aged and older individuals with schizophrenia and revise it (1st year); and (3) to examine the effects of the balance training program on balance, cognitive functions, and the muscular endurance of lower extremities (2nd to 3rd year).
Methods: For the effectiveness analysis phase, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG\&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Contribution: The study uses cognitive and balance dual task training and expect better outcomes on balance improvement. The program can serve as an evidence- based program to prevent and to decelerate the disability process from people with mental illness. The CogBals software developed by researchers and training in a group format is good to promote in the clinical setting with less manpower.
Study:
NCT05341804
Study Brief:
Protocol Section:
NCT05341804