NCT05420532

Brief Summary

The study aims to designing virtual reality-based testing and rehabilitation software for people with multiple sclerosis and assess the feasibility of software. Also, the effects of an 8-week virtual reality-based upper extremity training in persons with multiple sclerosis will be investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

June 10, 2022

Last Update Submit

June 10, 2022

Conditions

Keywords

multiple sclerosisvirtual realityexergaming

Outcome Measures

Primary Outcomes (1)

  • Nine-Hole Peg Test

    The Nine-Hole Peg Test is used to assess manual dexterity performance. It requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Two trials for each hand are performed and the score is the average time. Higher scores indicate less manual dexterity performance.

    Change from Baseline at 8 weeks

Secondary Outcomes (3)

  • Jamar Hand Dynamometer

    Change from Baseline at 8 weeks

  • Arm Function in Multiple Sclerosis Questionnaire

    Change from Baseline at 8 weeks

  • The User Satisfaction Evaluation Questionnaire

    immediately after the session

Other Outcomes (1)

  • Expanded Disability Status Scale

    At baseline

Study Arms (1)

Exergaming Group

EXPERIMENTAL

A video game-based physical activity training will be applied under a physiotherapist supervision for 1 days/week for 8 weeks.

Other: Exergaming

Interventions

A video game-based physical activity training applied using a commercial game console.

Exergaming Group

Eligibility Criteria

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

You may qualify if:

  • Having a definitive diagnosis of MS according to the 2017 McDonald criteria
  • Being over 18 years old
  • To be willing to participate in the study.

You may not qualify if:

  • Having a neurological disease other than MS
  • Cognitive disability at a level that hinders assessment and treatment.
  • Having a relapse 30 days before or during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Serkan Ozakbas, MD

CONTACT

Asiye Tuba Ozdogar, Research Assisstant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

January 30, 2022

Primary Completion

July 15, 2023

Study Completion

August 30, 2023

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations