NCT06641336

Brief Summary

The study aims to explore the patients' perspective on usability and feasibility of the RehAtt™ mixed-reality system during upper limb, gait and balance function rehabilitation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

October 11, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

rehabilitationmixed realitymotor rehabilitationpatients' perspective

Outcome Measures

Primary Outcomes (1)

  • Semi-structured interview

    The interview was based on a questionnaire that included rating-scale-based questions on mixed-reality therapy meeting the patient's needs, frustration during the exercise, ease of use, difficulties encountered, motivational aspect, likability and usefulness of each exercise, and open-ended questions on motivation, overall view of the mixed-reality system and possible unwanted effects.

    On the day of the end of the intervention

Study Arms (1)

RehAtt

EXPERIMENTAL

Each patient was included in the introduction session (performed by a psychologist), three sessions of occupational therapy and three sessions of physiotherapy. Each session lasted for 30 minutes. Occupational-therapy training was focused on activities aimed at improving upper limb function; physiotherapy training was focused on balance, walking and standing.

Device: RehAtt

Interventions

RehAttDEVICE

Each patient received the RehAtt intervention.

RehAtt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first ischaemic or hemorrhagic stroke,
  • one-sided hemiparesis,
  • adequate cognitive abilities.

You may not qualify if:

  • severe cognitive impairment,
  • aphasia,
  • known presence of an epileptic seizure in the last year,
  • other orthopaedic and neurological diseases affecting sensory or motor functions,
  • inability to sit independently,
  • severe visual impairment,
  • severe depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nataša Bizovičar, MD, PhD

    University Rehabilitation Institute, Republic of Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Metka Moharić, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 15, 2024

Study Start

October 11, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations