About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Balance impairment due cerebrovascular diseases or neurodegenerative diseases.
Being able to mantain standing for 2 minuts without assistance.
Berg scale ≥21
Age ≥18
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Balance Training Using Augmented Reality
Other interventionThe intervention will be carried out in two phases. The first phase will take place at Vall d\&#39;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").
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Adherence (Home)
Time the Augmentad reality system is used in comparision to the scheduled dosage.
Secondary outcomes
Berg Balance Scale
The Berg Balance Scale is a 14-item scale that assesses balance and fall risk in adults. Patients receive a score from 0-4 on their ability to meet these balance dimensions. A global score can be calculated out of 56. A score of 0 represents an inability to complete the item, and a score of 56 represents the ability to independently complete the item.
Postural Sway
Quantitative static balance assement. It will be assessed using Ned SVE/IBE system for postural assessment.
Five Times Sit to Stand Test (FTSS)
The Five Times Sit to Stand Test is a highly reliable tool for assessing lower limbs strengh and balance control and is used to detect risk of fall in enderly and stroke patients. In this test the participants are instructed to stand up from a chair five times as fast as possible.
The Activities-specific Balance Confidence (ABC) Scale.
\&amp;-item self-report measure in wich patients rate their balance confidence for performing activities.
Other outcomes
The Montreal Cognitive Assesment (MoCA)
Cognitive test validated as a highly sensitive tool for early detection of mild cognitive impairment. MoCA assesses short term memory, visuospacial abilities, executive functions, attention, concentration and working memory, and orientation to time and place.
Sponsors and contacts
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Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
Eodyne Systems SL
Collaborator