CClinicalTrials.gg
Status unknownNCT05639517Updated Feb 10, 2023

The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients

An interventional study of Augmented Reality Based Telerehabilitation Application and Training face-to-face in Multiple Sclerosis, sponsored by Ankara Yildirim Beyazıt University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Core stability, which is affected from the early period in with patients Multiple Sclerosis (PwMS), is due to deterioration in the somatosensory, motor and musculoskeletal systems. Based on the knowledge that core stability is effective on many functions, it is seen that trunk stabilization exercises are included in the physiotherapy and rehabilitation programs of patients. However, the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training in PwMS, has not been adequately investigated in the literature. The aim of the study is to investigate the effectiveness of augmented reality-based telerehabilitation application, which includes trunk stabilization training, on neuromuscular and sensorimotor parameters in PwMS.

02

Conditions studied

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 228 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with relapsing remitting MS by a neurologist,
  • Having a disability level between 1 and 5 according to the Expanded Disability Status Scale (EDSS),
  • Those who get over 24 points in the Standardized Mini Mental State Test (SMMT),
  • Those who have not had an MS attack in the last three months,
  • Volunteer individuals

Exclusion criteria

Exclusion Criteria:

  • Receiving corticosteroid therapy in the last 4 weeks,
  • Having additional neurological disease that may cause balance disorder
  • Individuals who have had surgery related to the spine, hip, knee or ankle
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Group 1

    Patients in this group will receive spinal stabilization training through augmented reality based telerehabilitation application.

    Other: Augmented Reality Based Telerehabilitation Application

  • Active comparator
    Group 2

    Patients in this group will receive spinal stabilization training face-to-face.

    Other: Training face-to-face

Interventions

  • OtherAugmented Reality Based Telerehabilitation Application

    Spinal stabilization training with augmented reality-based telerehabilitation will be applied twice a week for 8 weeks.

  • OtherTraining face-to-face

    Spinal stabilization training will be applied face-to-face twice a week for 8 weeks.

06

What researchers measure

Primary outcomes

  1. Balance

    MiniBESTest will be used to evaluate the static and dynamic balance.It consists of 14 questions including antisipatuar postural reaction, reactive postural control, sensory orientation and dynamic balance. The test is scored between 0-28 points. The highest score indicates good balance.

    Time frame: Change from baseline at 8 weeks

Secondary outcomes

  1. Muscle Activity

    An 8-channel superficial EMG system will be used to measure signals from the quadriceps and tibialis anterior muscles.Electrodes will be placed according to SENIAM criteria.The signals received from the muscles of the individuals will be recorded during standing up from sitting. As a result, the average muscle activations of the muscles during the activity will be numerically recorded in %MVIC.

    Time frame: Change from baseline at 8 weeks

  2. Core Muscle Endurance-Trunk Flexor

    The trunk flexor test will be performed with the arms crossed over the thorax, the trunk at 60 degrees of flexion, and the knees and hips flexed to 90 degrees. The test will be finished when the participant is unable to maintain the position. The time will be recorded.As the time increases, the endurance decreases.

    Time frame: Change from baseline at 8 weeks

  3. Core Muscle Endurance- Trunk Extansor

    The trunk extensor test will be performed in the prone position, with the pelvis, hips and knees fixed to the bed. The participant will be asked to cross his arms over his body and position his body horizontally. The test will be finished when the participant is unable to maintain the horizontal position. The time will be recorded. As the time increases, the endurance decreases.

    Time frame: Change from baseline at 8 weeks

  4. Core Muscle Endurance- Side Bridge

    While the participants are in the side-lying position, they will raise their hips and align their bodies in a straight line by getting support from their feet and elbows. The time will be recorded by asking them to maintain the position as much as possible.As the time increases, the endurance decreases.

    Time frame: Change from baseline at 8 weeks

  5. Trunk Position Sense

    Inclinometer will be positioned at spinous process of 1th thoracic vertebrae and 1 sacral during trunk position sense assessment. Subject will be retreated to neutral position and asked to come back taught position while eyes closed. Test will be repeated 3 times and angle of deviation from 30 degree flexion position will be recorded and the average of the results will be taken.As the deflection angle increases, the sense of position deteriorates. As the deflection angle increases, the sense of position deteriorates.

    Time frame: Change from baseline at 8 weeks

  6. Spinal mobility

    Spinal Mouse device will be used to evaluate spinal mobility. Measurements will be made between the spinous process of the 7th cervical vertebra and approximately the level of the 3rd sacral vertebra. Maximum degrees of right-left lateral flexion in the frontal plane and maximum degrees of flexion-extension in the sagittal plane will be measured and recorded.As the degree increases, the deformity also increases.

    Time frame: Change from baseline at 8 weeks

  7. Fatique-Fatigue Severity Scale

    The Fatigue Severity Scale, which rates the severity of fatigue symptoms, consists of questions expressing 9 different conditions.A high score indicates increased fatigue severity. Patients with a score of \<4 will be considered "not tired", and patients with a score of \>4 will be considered "tired".

    Time frame: Change from baseline at 8 weeks

  8. Fatigue- Fatigue Impact Scale

    Each question ranges from 0 (no problem) to 4 (maximum problem) in the scale that evaluates cognitive status, physical condition and psychological status. High scores indicate fatigue.

    Time frame: Change from baseline at 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05639517
Lead sponsor
Ankara Yildirim Beyazıt University
Responsible party
Sponsor
First posted
Dec 6, 2022
Start date
Jan 30, 2023 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Dec 15, 2024 (estimated)
Last update
Feb 10, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion