Multiple SclerosisNCT05639517
The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients
A study testing Augmented Reality Based Telerehabilitation Application and Training face-to-face in people with Multiple Sclerosis, run by Ankara Yildirim Beyazıt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Augmented Reality Based Telerehabilitation Application and Training face-to-face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Augmented Reality Based Telerehabilitation Application, Training face-to-face
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Based Telerehabilitation ApplicationOther
Spinal stabilization training with augmented reality-based telerehabilitation will be applied twice a week for 8 weeks.
Training face-to-faceOther
Spinal stabilization training will be applied face-to-face twice a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients in this group will receive spinal stabilization training through augmented reality based telerehabilitation application. Receives: Other: Augmented Reality Based Telerehabilitation Application |
| Group 2 | Active comparator | Patients in this group will receive spinal stabilization training face-to-face. Receives: Other: Training face-to-face |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 8 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start30 Jan 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639517
- Sponsor's protocol ID
- 2022-985
- Status last verified
- Nov 2022
- First submitted
- 26 Nov 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Augmented Reality Based Telerehabilitation Application on Neuromuscular and Sensorimotor Parameters in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05639517
- Acronym / sponsor ID
- 2022-985
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Augmented Reality Based Telerehabilitation ApplicationPatients in this group will receive spinal stabilization training through augmented reality based telerehabilitation application. |
| Group 2 | Active comparator | Other: Training face-to-facePatients in this group will receive spinal stabilization training face-to-face. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality Based Telerehabilitation ApplicationSpinal stabilization training with augmented reality-based telerehabilitation will be applied twice a week for 8 weeks. | Other | Group 1 |
| Training face-to-faceSpinal stabilization training will be applied face-to-face twice a week for 8 weeks. | Other | Group 2 |
Primary outcome
Balance
Time frame: Change from baseline at 8 weeks
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.
8 secondary outcomes
Muscle Activity
Time frame: Change from baseline at 8 weeks
Core Muscle Endurance-Trunk Flexor
Time frame: Change from baseline at 8 weeks
Core Muscle Endurance- Trunk Extansor
Time frame: Change from baseline at 8 weeks
Core Muscle Endurance- Side Bridge
Time frame: Change from baseline at 8 weeks
Trunk Position Sense
Time frame: Change from baseline at 8 weeks
Spinal mobility
Time frame: Change from baseline at 8 weeks
Fatique-Fatigue Severity Scale
Time frame: Change from baseline at 8 weeks
Fatigue- Fatigue Impact Scale
Time frame: Change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Based Telerehabilitation Application and Training face-to-face in people with Multiple Sclerosis, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Change from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.