A Low-Cost Balance Training Platform Using Augmented Reality in Neurorehabilitation: a Usability Study

NCT06627387 | Recruiting

• 1 other identifier: PR(AT)309/2024
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the Usability, adherence, acceptance, and security of an augmented reality platform for balance training in patients with balance disorders due to degenerative injuries or cerebrovascular diseases. The main questions it aims to answer are:

• Is the augmented reality system usable, acceptable, and safe with good adherence?
• Does the system improve the balance in our population?
• Participants will be asked to assist at Vall d'Hebrón Hospital, where patients will undergo balance training under the supervision of a physiotherapist three days a week for four weeks.
• If the patients meet the inclusion criteria, the intervention will be extended for two more weeks at home.

Conditions

Postural Balance; Cerebrovascular Disorders; Neurodegenerative Diseases; Augmented Reality; Neurological Rehabilitation

Keywords

Augmented Reality; Postural balance; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (6)

• System Usability Scale (SUS)

  The System Usability Scale is a reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents, from Strongly Agree to Disagree Strongly. A value above 68 points is considered acceptable.

  "Week 4" "Week 6"

• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

  The instrument is a self-administered questionnaire assessing user satisfaction with assistive technology product and associated services.

  "Week 4" "Week 6"

• User Esperience Questionnaire (UEQ)

  The scales of the questionnaire cover comprehensive impression of user experience. Both classical usability aspects (efficiency, perspicuity, dependability) and user experience (originality stimulation) are measured. The items are scaled from -3 to +3. Thus, -3 represents the most negative answer, 0 a neutral answer, and +3 the most positive answer.

  "Week 4" "Week 6"

• Adherence (Home)

  Time the Augmentad reality system is used in comparision to the scheduled dosage.

  "Week 6"

• Adherence (Hospital)

  Total sessions scheduled for therapy compared to the number of sessions attended

  "Week 4"

• Ad-hoc questions

  Questions to assess the attitude towards the system and to gather data on privacy and feeling of stigma.

  "Day 0" "Week 4" "Week 6"

Secondary Outcomes (5)

• Berg Balance Scale

  "Day 0" "Week 4" "Week 6"

• Postural Sway

  "Day 0" "Week 4" "Week 6"

• Five Times Sit to Stand Test (FTSS)

  "Day 0" "Week 4" "Week 6"

• The Activities-specific Balance Confidence (ABC) Scale.

  "Day 0" "Week 4" "Week 6"

• The EuroQol-5 Dimension-5 Level (EQ-5D-5L)

  "Day 0" "Week 4" "Week 6"

Other Outcomes (1)

• The Montreal Cognitive Assesment (MoCA)

  "Day 0"

Study Arms (1)

Balance training

EXPERIMENTAL

The intervention will be carried out in two phases. The first phase will take place at Vall d'Hebron Hospital, where patients will undergo balance training under the supervision of a physiotherapist. The scheduled dose will be 60 minutes a day, 3 days a week for 4 weeks. If the patients meet the inclusion criteria, the intervention will be extended for two more weeks at home.

Other: Balance Training Using Augmented Reality

Interventions

Balance Training Using Augmented Reality OTHER

The intervention will be carried out in two phases. The first phase will take place at Vall d\'Hebron Hospital, where patients will undergo balance training under the supervision of a physiotherapist. The scheduled dose will be 60 minutes daily, three days a week for four weeks. If the patients meet the inclusion criteria, the intervention will be extended for two more weeks at home. For this task, the involvement of a family member as a training partner will be essential. Relatives will receive training on using the system in the hospital and must be present whenever the patient undergoes the training at home. Three assessments will be carried out during the six weeks of the study. At the beginning of the intervention ("Day 0" ), a second is once the hospital intervention has been carried out ("Week 4" ), and the last is once the home intervention has been carried out ("Week 6").

Also known as: Personalized Health Assistance SystEM (PHASE)

Balance training

Eligibility Criteria

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

You may qualify if:

• Balance impairment due cerebrovascular diseases or neurodegenerative diseases.
• Being able to mantain standing for 2 minuts without assistance.
• Berg scale ≥21
• Age ≥18
• Signing informed consent
• To have a training partner during the exercises at home.
• No fall attempt during hospital intervention
• No have enough space to train safely at their home.
• Being familiar with technological devices such a laptop, tablets or inteligent cellphones.

You may not qualify if:

• The presence of a condition or abnormality that could compromise the patient's safety.
• Severe cognitive impairments tha prevent the execution of the xperiment (MoCA \<19)
• Presence of sensory aphasia.
• Diagnostic of conduct disorders.
• Presence of severe neglect.
• Spasticity =4 in MAS lower limb.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Eodyne Systems SL: collaborator

Study Sites (1)

Hospital Vall D'Hebrón

Barcelona, Barcelona, 08035, Spain

RECRUITING

Related Publications (5)

• Truijen S, Abdullahi A, Bijsterbosch D, van Zoest E, Conijn M, Wang Y, Struyf N, Saeys W. Effect of home-based virtual reality training and telerehabilitation on balance in individuals with Parkinson disease, multiple sclerosis, and stroke: a systematic review and meta-analysis. Neurol Sci. 2022 May;43(5):2995-3006. doi: 10.1007/s10072-021-05855-2. Epub 2022 Feb 17.

  PMID: 35175439 BACKGROUND

• Lim JH, Lee HS, Song CS. Home-based rehabilitation programs on postural balance, walking, and quality of life in patients with stroke: A single-blind, randomized controlled trial. Medicine (Baltimore). 2021 Sep 3;100(35):e27154. doi: 10.1097/MD.0000000000027154.

  PMID: 34477171 BACKGROUND

• Keller JL, Bastian AJ. A home balance exercise program improves walking in people with cerebellar ataxia. Neurorehabil Neural Repair. 2014 Oct;28(8):770-8. doi: 10.1177/1545968314522350. Epub 2014 Feb 13.

  PMID: 24526707 BACKGROUND

• Lei C, Sunzi K, Dai F, Liu X, Wang Y, Zhang B, He L, Ju M. Effects of virtual reality rehabilitation training on gait and balance in patients with Parkinson's disease: A systematic review. PLoS One. 2019 Nov 7;14(11):e0224819. doi: 10.1371/journal.pone.0224819. eCollection 2019.

  PMID: 31697777 BACKGROUND

• Iruthayarajah J, McIntyre A, Cotoi A, Macaluso S, Teasell R. The use of virtual reality for balance among individuals with chronic stroke: a systematic review and meta-analysis. Top Stroke Rehabil. 2017 Jan;24(1):68-79. doi: 10.1080/10749357.2016.1192361. Epub 2016 Jun 16.

  PMID: 27309680 BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Susana Rodriguez Gonzalez, MD

  VHIR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana Rodriguez Gonzalez, MD

CONTACT

+34 607609067; susana.rodriguezgonzalez@vallhebron.cat

Marta Fernandez-Lobera, PhD

CONTACT

+34 677517345; marta.fernandez@vhir.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: usability study

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: October 4, 2024
• Study Start: August 6, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)