Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke

NCT04003571 | Unknown

• 1 other identifier: N201904041
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: AR and FES group (10), Traditional physiotherapy group (10).

Conditions

Stroke

Keywords

stroke; augmented reality; functional electrical stimulation

Outcome Measures

Primary Outcomes (3)

• Change of Time Up Go test (TUG)

  The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

• Change of Berg Balance Scale (BBS)

  Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

• Change of Functional magnetic resonance imaging (fMRI)

  Our study will use 3 Tesla magnetic resonance imaging\[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)\] for functional magnetic resonance imaging. Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters. The EPI scan for 525 seconds. All subjects are asked to close their eyes and supine. our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

Secondary Outcomes (5)

• Change of Fugl-Meyer Assessment (FMA)-Lower extremity

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

• Change of Modified Ashworth Scale (MAS)

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

• Change of Motor evoked potential (MEP)

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

• Change of 10 meter walking test

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

• Change of Diffusion Tensor Imaging (DTI)

  Measurement before and after intervention ( week 0 and at the end of week 8) in both groups

Study Arms (2)

Augmented reality with functional electrical stimulation group

EXPERIMENTAL

Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks.

Behavioral: Augmented Reality with Functional Electrical Stimulation group

Traditional physiotherapy group

ACTIVE COMPARATOR

Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks.

Behavioral: Traditional physiotherapy

Interventions

Augmented Reality with Functional Electrical Stimulation group BEHAVIORAL

Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.

Augmented reality with functional electrical stimulation group

Traditional physiotherapy BEHAVIORAL

Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .

Traditional physiotherapy group

Eligibility Criteria

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

You may qualify if:

• Patients present with unilateral hemiplegia caused by a first-ever stroke
• Brunnstrom stage above stage II, mental health was stable
• Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)

You may not qualify if:

• Patients having other neurologic problems, which can affect balance and walking ability
• Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
• severe hearing or eye problem

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical university Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chien-Hung Lai, MD PhD

CONTACT

886-2-27372181; chlai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: October 10, 2019
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

TW (1)