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

NCT06476431 | Enrolling By Invitation

• 1 other identifier: SYU 2024-05-016-004
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; cognitive training; gait; cognition; fall

Outcome Measures

Primary Outcomes (2)

• 6 minutes walk test

  The 6-minute walk test is a method for assessing functional performance and walking endurance in stroke patients. A straight line of 30 meters is drawn on the floor for the subject to recognize, and cones are placed at each end. During the test, the patient is asked to walk as much distance as possible as quickly as possible while walking to and from the 30-meter section, but the walking speed and rest periods are self-regulated according to the patient's ability. After starting on cue, to eliminate motivational errors during the walk, the therapist speaks only to the subjects about the remaining time and instructions, and asks them to sit in a chair after the end of the walk. The therapist records the distance walked and the number and duration of breaks during the 6-minute walk.

  From enrollment to the end of treatment at 4 weeks

• Dual task Interference

  The 10-meter walk test will be calculated by substituting 100-7-7-7... into the formula. The single task gait speed will be calculated by measuring the gait time, finding the speed, and substituting it into the formula while walking a distance of 10 meters. The dual task gait speed will be calculated by measuring the gait time, finding the speed, and substituting it into the formula while walking a distance of 10 meters and having the therapist calculate 100-7-7 next to participants.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (5)

• Trail Making Test type A/B

  From enrollment to the end of treatment at 4 weeks

• 10m walk test

  From enrollment to the end of treatment at 4 weeks

• Digit Span

  From enrollment to the end of treatment at 4 weeks

• Korea version of Falls Efficacy Scale-International

  From enrollment to the end of treatment at 4 weeks

• Timed Up and Go test

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

experimental Group 1

ACTIVE COMPARATOR

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

Other: dual task

experimental Group 2

ACTIVE COMPARATOR

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

Other: non dual task

Interventions

dual task 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 1

non dual task 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.

experimental Group 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Rochester hospital

Uijeongbu-si, Gyeonggi-do, 11753, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)