Effects of a Cognitive Gait Dual Task With Smartglasses in Stroke Patients

NCT ID: NCT06476431

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-09-01

Brief Summary

The aim of this study is to find out to determine changes in gait, dual-task interference, cognition, and fall scores during a cognitive walking dual task on a treadmill while wearing augmented reality-based smartglasses in stroke patients.

Before the experiment, the investigators measure the subjects general characteristics, gait, cognition, dual-task interference, and fall risk. This will be done 3 times a week for 30 minutes for 4 weeks.

Group 1 will perform a cognitive task with smart glasses and a gait task on a treadmill at the same time. The training will consist of 10 minutes of treadmill walking without incline, followed by 5 minutes of rest, followed by 10 minutes of treadmill walking with incline, followed by 5 minutes of rest.

Group 2 will perform only treadmill walking without the cognitive task. Same as the experimental group: 10 minutes without treadmill incline, followed by 5 minutes rest, followed by 10 minutes treadmill incline, followed by 5 minutes rest.

At the end of the 4-week training program, the investigators will measure walking ability, cognitive performance, dual-task interference, and fall risk as assessed before the experiment.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

experimental Group 1

The experimental group 1 performs a dual cognitive task on a treadmill.

Group Type: ACTIVE_COMPARATOR

dual task

Intervention Type: OTHER

The intervention program will be a program created by the researcher based on the iPad application Brainilis The tasks (logic, memory, math, and concentration) will be performed using a Type-C cable connected to the smartglasses, and the difficulty level will be adjusted according to the individual's cognitive ability. The experimental group will perform cognitive tasks with the smartglasses while simultaneously performing a walking task on a treadmill. This will be done three times a week for 30 minutes for four weeks. The subjects will not be able to touch the answers, so they will tell the therapist what they think is the correct answer and the therapist will touch the iPad to move on to the next step. The investigators will start with 10 minutes on the treadmill without incline, followed by a 5 minute break, then 10 minutes on the treadmill with incline, followed by a 5 minute break. It will run for 30 minutes, 3 times a week for 4 weeks.

experimental Group 2

The experimental group 2 performs a non-dual task on a treadmill.

Group Type: ACTIVE_COMPARATOR

non dual task

Intervention Type: OTHER

No cognitive task, just treadmill walking. Same as the experimental group 1: 10 minutes without treadmill incline, followed by a 5 minute rest period, followed by 10 minutes on the treadmill with incline, followed by a 5 minute rest period. It will run for 30 minutes, 3 times a week for 4 weeks.

Interventions

dual task

The intervention program will be a program created by the researcher based on the iPad application Brainilis The tasks (logic, memory, math, and concentration) will be performed using a Type-C cable connected to the smartglasses, and the difficulty level will be adjusted according to the individual's cognitive ability. The experimental group will perform cognitive tasks with the smartglasses while simultaneously performing a walking task on a treadmill. This will be done three times a week for 30 minutes for four weeks. The subjects will not be able to touch the answers, so they will tell the therapist what they think is the correct answer and the therapist will touch the iPad to move on to the next step. The investigators will start with 10 minutes on the treadmill without incline, followed by a 5 minute break, then 10 minutes on the treadmill with incline, followed by a 5 minute break. It will run for 30 minutes, 3 times a week for 4 weeks.

Intervention Type: OTHER

non dual task

No cognitive task, just treadmill walking. Same as the experimental group 1: 10 minutes without treadmill incline, followed by a 5 minute rest period, followed by 10 minutes on the treadmill with incline, followed by a 5 minute rest period. It will run for 30 minutes, 3 times a week for 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants have hemiplegia from a stroke
• Able to walk 10 meters independently without assistive devices
• Stable health to participate in the study protocol and interventions

Exclusion Criteria

• Have comorbidities or disabilities other than stroke that may interfere with gait training
• Have an uncontrolled medical condition for which exercise is contraindicated.
• Have a neurological or orthopedic condition that may interfere with the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahmyook University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rochester hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

SYU 2024-05-016-004

Identifier Type: -

Identifier Source: org_study_id