NCT06874764

Brief Summary

When the literature is examined, balance disorders, walking disorders and cognitive problems are frequently observed in Multiple Sclerosis(MS) patients. Using technologically supported equipment such as reaction systems, cognitive function measurements have been successfully performed in the elderly, and improvements in reaction times have been detected in athletes when used for training purposes. The primary aim of the study is to provide improvement in agility and cognitive functions in patients using a technology-supported reaction device. In addition, it aims to improve balance function assessed with static posturography and gait parameters assessed with gait analysis by increasing sensory input and shortening reaction time. As a result of the agility and cognitive training performed, we aim to provide improvement in MS-related quality of life and decrease in disability.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress60%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

March 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

March 3, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

Multiple sclerosisCognitiveVirtual realityAgilityTrainingGait

Outcome Measures

Primary Outcomes (1)

  • Cognitive Functions

    the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) is a battery with demonstrated validity and reliability in Turkish, consisting of the California Verbal Learning Test II (CVLT II), Symbol Digit Modalities Test (SDMT) and Brief Visuospatial Memory Test-Revised (BVMTR) subscales, used to assess cognitive status in MS patients SDMT: There is no lower or upper limit for scoring. A higher number of correct answers (higher scores) is associated with better results. CVLTII:The upper limit for scoring is 80. A higher number of correct answers (higher scores) is associated with better results. BVMTR:The score range is 0-12. Higher scores are associated with better outcomes.

    8th week

Secondary Outcomes (14)

  • Balance assessment

    8th week

  • Anxiety and Depression Status

    8th week

  • Fatigue Assessment

    8th week

  • MS Quality of Life

    8th week

  • Static Posture Assessment(Static Balance)

    8th week

  • +9 more secondary outcomes

Study Arms (2)

Training Group

EXPERIMENTAL

The intervention group will be trained with a difficulty appropriate to their individual levels for 2 months using the reaction system 2 days a week to improve agility and cognitive functions, and if the participant can easily perform the relevant training, the difficulty will be increased by one level. Agility training aims to reach the light side sensor with the hand in order and to do this within the specified time, and aims to speed up the participant's reaction time in the foreground. Cognitive training consists of different trainings such as finding the different image illuminated in 8 sensors, finding two identical signs, remembering the order in which the sensors light up, and touching the sensors in that order. These trainings aim to increase the participant's quick thinking and decision making, and to improve attention, visual memory, visual processing speed, and cognitive functions. Each training session will last approximately 30 minutes.

Other: Wireless Lighting Reaction System Training(Agility plus Cognitive)

Control Group

NO INTERVENTION

The control group will not receive any intervention. They will be asked to continue their normal lives.

Interventions

Agility training and Cognitive trainings(cognitive trainings ready within the device: Eye for detail, Hawk eye, Juggle Factor)

Training Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-55
  • Having a definite MS diagnosis according to the 2017 McDonald criteria.
  • EDSS score of 4 or below
  • Being able to communicate (speaking and understanding Turkish, no speech disorders)

You may not qualify if:

  • Regular exercise in the last 6 months
  • Having an MS attack in the last month
  • Having an MS attack during the study period
  • Presence of additional accompanying neurological diseases
  • Use of dalfampridine
  • Use of antipsychotic and psychostimulant drugs
  • Drug and alcohol addiction
  • Pregnancy, breastfeeding
  • No chronic systemic disease preventing exercise
  • Patients who cannot reach the targeted exercise level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Sport Medicine Clinic

Izmir, Bornova, Turkey (TĂ¼rkiye)

Location

Related Publications (33)

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 13, 2025

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations