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

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Augmented Reality Based Telerehabilitation Application
Training face-to-face
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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".
    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.

    Full Information

    First Posted
    November 26, 2022
    Last Updated
    February 9, 2023
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05639517
    Brief Title
    The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients
    Official Title
    The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 30, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    December 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive spinal stabilization training through augmented reality based telerehabilitation application.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group will receive spinal stabilization training face-to-face.
    Intervention Type
    Other
    Intervention Name(s)
    Augmented Reality Based Telerehabilitation Application
    Intervention Description
    Spinal stabilization training with augmented reality-based telerehabilitation will be applied twice a week for 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Training face-to-face
    Intervention Description
    Spinal stabilization training will be applied face-to-face twice a week for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Balance
    Description
    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 Outcome Measure Information:
    Title
    Muscle Activity
    Description
    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
    Title
    Core Muscle Endurance-Trunk Flexor
    Description
    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
    Title
    Core Muscle Endurance- Trunk Extansor
    Description
    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
    Title
    Core Muscle Endurance- Side Bridge
    Description
    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
    Title
    Trunk Position Sense
    Description
    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
    Title
    Spinal mobility
    Description
    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
    Title
    Fatique-Fatigue Severity Scale
    Description
    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
    Title
    Fatigue- Fatigue Impact Scale
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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