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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Augmented Reality Based Telerehabilitation Application; Other: Training face-to-face

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Patients in this group will receive spinal stabilization training through augmented reality based telerehabilitation application.	Other: Augmented Reality Based Telerehabilitation Application; Spinal stabilization training with augmented reality-based telerehabilitation will be applied twice a week for 8 weeks.
ACTIVE_COMPARATOR: Group 2; Patients in this group will receive spinal stabilization training face-to-face.	Other: Training face-to-face; Spinal stabilization training will be applied face-to-face twice a week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks
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".	Change from baseline at 8 weeks
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.	Change from baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 30, 2023
• Primary Completion (ANTICIPATED): September 30, 2024
• Study Completion (ANTICIPATED): December 15, 2024

Study Registration Dates

• First Submitted: November 26, 2022
• First Submitted That Met QC Criteria: November 26, 2022
• First Posted (ACTUAL): December 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2022-985

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No