RehabilitationNCT04212689
Virtual Reality Approach in Multiple Sclerosis
A study testing Game Based Virtual Reality Exercises and Conventional Physiotherapy and Rehabilitation in people with Rehabilitation and Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effects of game-based virtual reality exercise added to conventional physiotherapy and rehabilitation program in patients with Multiple Sclerosis (MS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rehabilitation, Multiple Sclerosis
- What is being tested?
- Game Based Virtual Reality Exercises and Conventional Physiotherapy and Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2020to 1 Jun 2021
- 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
- Volunteered to participate in the study,
- Aged 18-65 years
- Having a score between 1.5 - 7 according to Expanded Disability Status Scale (EDSS)
Who cannot join
- Any visual or hearing problem,
- Other neurological, orthopedic or rheumatic problems that may restrict shoulder motion or cause pain,
- Having a physical disability or uncontrolled chronic systemic disease,
- Major trauma,
- Treatment for shoulder problems within the last 6 months,
- History of epileptic attacks
- Not being stable for MS attacks during the last 3 months
Trial locations and contacts
1 site in 1 country.
Halit Selcuk, MSc contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cadde Tıp Merkezi - Cadde Medical Center
Istanbul
Nimet Sermenli Aydin, MSc
About this study
Official title: The Effectiveness of Game-Based Virtual Reality Approach in Patients With Multiple Sclerosis
The aim of our study is to investigate the effects of game-based virtual reality exercise added to conventional physiotherapy and rehabilitation program in patients with Multiple Sclerosis (MS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied.
Read the detailed description
Multiple Sclerosis (MS) is a neuromuscular disease that causes various degrees of disability in mobility and functional activities, causing restrictions on the individual's social and professional life, creating advanced disability and impairing quality of life. Problems in upper limb function affect quality of life and functional independence of the patients. Recovery of restricted daily life functions (such as dressing, personal care, eating and body care) is one of the main goals of physiotherapy and rehabilitation in MS and currently, conventional physiotherapy and rehabilitation methods are most commonly used. The main purpose of this method is to reduce pain, increase range of motion and muscle strength. With the developing technology various virtual reality applications have begun to take place in physiotherapy and rehabilitation programs recently. These virtual reality applications are used to motivate the patient and keep their interest in the rehabilitation. The aim of our study is to investigate the effects of game-based virtual reality exercises added to conventional physiotherapy and rehabilitation program in patients with MS.
- Conditions
- Rehabilitation, Multiple Sclerosis
- Being tested
- Game Based Virtual Reality Exercises, Conventional Physiotherapy and Rehabilitation
- Keywords
- Rehabilitation, Physiotherapy and Rehabilitation, Virtual Reality, Multiple Sclerosis, Upper extremity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Based Virtual Reality ExercisesDevice
A game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons.
Conventional Physiotherapy and RehabilitationOther
The conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Number of participants in this group is anticipated to be 20. Conventional physiotherapy and rehabilitation methods will be applied to this group. Physiotherapy approaches include stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy. Receives: Other: Conventional Physiotherapy and Rehabilitation |
| Study Group | Active comparator | Number of participants in this group is anticipated to be 20. Participants in this group will be receiving conventional physiotherapy and rehabilitation methods and 10 minutes of exercise with the game-based virtual reality system (USE-IT). In the USE-IT system two games will be played for 5 minutes each. Receives: Device: Game Based Virtual Reality Exercises; Other: Conventional Physiotherapy and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion from baseline to week 4
The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.
Measured: 4 weeks
Change in level of pain from baseline to week 4
Level of Pain will be assessed with Visual Analogue Scale (VAS). It is widely used among the methods of measuring the severity of pain. Scale is a 10 cm ruler, participants will mark the level of pain between 0-10 cm, 0 would means ''no pain'' and 10 would means ''worst possible pain''.
Measured: 4 weeks
Change in disability of the upper extremity from baseline to week 4
Disability of the upper extremities will be assessed with 'The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire'. It is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time.
Measured: 4 weeks
Change in pain threshold from baseline to week 4
The pain threshold will be measured with a digital algometer device. Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.
Measured: 4 weeks
Change in proprioception from baseline to week 4
Proprioception will be evaluated with 'Marmara Visual Auditory Joint Education Device (MarVAJED) which was developed by the Faculty of Health Sciences of Marmara University, Istanbul. This device evaluates motion deficits of joints, analyzes joint position sense, provides biofeedback support to increase joint control and also directs to controlled exercises. It analyzes the motion of the joint with the help of small sensors and transfers the data obtained to the mobile phone, tablet or computer.
Measured: 4 weeks
Change in kinesiophobia from baseline to week 4
In the assessment of kinesiophobia 'Tampa Kinesiophobia Scale (TKS)' will be used. It is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury.
Measured: 4 weeks
Satisfaction of the Treatment
An objective test that evaluates the satisfaction of the patient from pain status, functionality, treatment and physiotherapist after treatment will be assessed with 4 questions, and each question is given a score of 0-10 using the VAS scale. 0 means ''I am not satisfied at all'', 10 means ''I am very satisfied''.
Measured: 4 weeks
Change in muscle strength from baseline to week 4
The muscle strength of shoulder flexion, abduction, adduction, external and internal rotation movements will be evaluated by using the Baseline Push-Pull (New York) dynamometer. Results will be calculated in kg (1 lb = 0.454 kg). The patient's arm will be stabilized and the patient will be asked to show maximum resistance within 2 sec against the dynamometer placed and then hold it for 5 seconds at this position and power. The measurement will be repeated twice and recorded with the average of these two values.
Measured: 4 weeks
Change in disability of the fingers from baseline to week 4
The Nine-Hole Peg Test (9HPT) will be used to measure finger dexterity. The test is administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the test activity, recorded in seconds.
Measured: 4 weeks
Change in spasticity from baseline to week 4
Spasticity will be defined with Modified Ashworth Scale (MAS). The MAS measures resistance during passive soft-tissue stretching. Scoring: 0= normal tone. 1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension. 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM. 2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3= considerable increase in muscle tone, passive movement difficult. 4= affected part(s) rigid in flexion or extension.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start20 Jan 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nimet Sermenli Aydın, MSc, Principal investigator, Marmara University Institute of Health SciencesDilara Merve Sari, MSc, Principal investigator, Marmara University Institute of Health SciencesZubeyir Sari, Assoc Prof, Study director, Marmara University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212689
- Sponsor's protocol ID
- 31.10.2019/104
- Status last verified
- Sep 2020
- First submitted
- 25 Dec 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
PubMed 25206611Arman N, Tarakci E, Tarakci D, Kasapcopur O. Effects of Video Games-Based Task-Oriented Activity Training (Xbox 360 Kinect) on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):174-181. doi: 10.1097/PHM.0000000000001001.
PubMed 30020092Burdea GC. Virtual rehabilitation--benefits and challenges. Methods Inf Med. 2003;42(5):519-23.
PubMed 14654886Rubin BD, Kibler WB. Fundamental principles of shoulder rehabilitation: conservative to postoperative management. Arthroscopy. 2002 Nov-Dec;18(9 Suppl 2):29-39. doi: 10.1053/jars.2002.36507. No abstract available.
PubMed 12426529Chen CC. Multimedia virtualized environment for shoulder pain rehabilitation. J Phys Ther Sci. 2016 Apr;28(4):1349-54. doi: 10.1589/jpts.28.1349. Epub 2016 Apr 28.
PubMed 27190481Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
PubMed 8602410Bjartmar C, Trapp BD. Axonal and neuronal degeneration in multiple sclerosis: mechanisms and functional consequences. Curr Opin Neurol. 2001 Jun;14(3):271-8. doi: 10.1097/00019052-200106000-00003.
PubMed 11371748Crayton H, Heyman RA, Rossman HS. A multimodal approach to managing the symptoms of multiple sclerosis. Neurology. 2004 Dec 14;63(11 Suppl 5):S12-8. doi: 10.1212/wnl.63.11_suppl_5.s12.
PubMed 15596731Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08.
PubMed 22020457Feys P, Helsen W, Liu X, Mooren D, Albrecht H, Nuttin B, Ketelaer P. Effects of peripheral cooling on intention tremor in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2005 Mar;76(3):373-9. doi: 10.1136/jnnp.2004.044305.
PubMed 15716530Hiller LB, Wade CK. Upper extremity functional assessment scales in children with Duchenne muscular dystrophy: a comparison. Arch Phys Med Rehabil. 1992 Jun;73(6):527-34.
PubMed 1622300Peresedova AV, Chernikova LA, Zavalishin IA. [Physical rehabilitation in multiple sclerosis: general principles and high-tech approaches]. Vestn Ross Akad Med Nauk. 2013;(10):14-21. Russian.
PubMed 24640715
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Game-Based Virtual Reality Approach in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04212689
- Acronym / sponsor ID
- 31.10.2019/104
- Conditions
- Rehabilitation, Multiple Sclerosis
- Keywords
- Rehabilitation, Physiotherapy and Rehabilitation, Virtual Reality, Multiple Sclerosis, Upper extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 27 Dec 2019 (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.
The aim of our study is to investigate the effects of game-based virtual reality exercise added to conventional physiotherapy and rehabilitation program in patients with Multiple Sclerosis (MS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied.
Detailed description
Multiple Sclerosis (MS) is a neuromuscular disease that causes various degrees of disability in mobility and functional activities, causing restrictions on the individual's social and professional life, creating advanced disability and impairing quality of life. Problems in upper limb function affect quality of life and functional independence of the patients. Recovery of restricted daily life functions (such as dressing, personal care, eating and body care) is one of the main goals of physiotherapy and rehabilitation in MS and currently, conventional physiotherapy and rehabilitation methods are most commonly used. The main purpose of this method is to reduce pain, increase range of motion and muscle strength. With the developing technology various virtual reality applications have begun to take place in physiotherapy and rehabilitation programs recently. These virtual reality applications are used to motivate the patient and keep their interest in the rehabilitation. The aim of our study is to investigate the effects of game-based virtual reality exercises added to conventional physiotherapy and rehabilitation program in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Physiotherapy and RehabilitationNumber of participants in this group is anticipated to be 20. Conventional physiotherapy and rehabilitation methods will be applied to this group. Physiotherapy approaches include stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy. |
| Study Group | Active comparator | Device: Game Based Virtual Reality Exercises, Other: Conventional Physiotherapy and RehabilitationNumber of participants in this group is anticipated to be 20. Participants in this group will be receiving conventional physiotherapy and rehabilitation methods and 10 minutes of exercise with the game-based virtual reality system (USE-IT). In the USE-IT system two games will be played for 5 minutes each. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteered to participate in the study,
- Aged 18-65 years
- Having a score between 1.5 - 7 according to Expanded Disability Status Scale (EDSS)
Key exclusion criteria (7 listed)
- Any visual or hearing problem,
- Other neurological, orthopedic or rheumatic problems that may restrict shoulder motion or cause pain,
- Having a physical disability or uncontrolled chronic systemic disease,
- Major trauma,
- Treatment for shoulder problems within the last 6 months,
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 |
|---|---|---|
| Game Based Virtual Reality ExercisesA game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons. | Device | Study Group |
| Conventional Physiotherapy and RehabilitationThe conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy. | Other | Control Group, Study Group |
Primary outcome
Change in range of motion from baseline to week 4
Time frame: 4 weeks
The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.
Change in level of pain from baseline to week 4
Time frame: 4 weeks
Level of Pain will be assessed with Visual Analogue Scale (VAS). It is widely used among the methods of measuring the severity of pain. Scale is a 10 cm ruler, participants will mark the level of pain between 0-10 cm, 0 would means ''no pain'' and 10 would means ''worst possible pain''.
Change in disability of the upper extremity from baseline to week 4
Time frame: 4 weeks
Disability of the upper extremities will be assessed with 'The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire'. It is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time.
Change in pain threshold from baseline to week 4
Time frame: 4 weeks
The pain threshold will be measured with a digital algometer device. Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.
Change in proprioception from baseline to week 4
Time frame: 4 weeks
Proprioception will be evaluated with 'Marmara Visual Auditory Joint Education Device (MarVAJED) which was developed by the Faculty of Health Sciences of Marmara University, Istanbul. This device evaluates motion deficits of joints, analyzes joint position sense, provides biofeedback support to increase joint control and also directs to controlled exercises. It analyzes the motion of the joint with the help of small sensors and transfers the data obtained to the mobile phone, tablet or computer.
Change in kinesiophobia from baseline to week 4
Time frame: 4 weeks
In the assessment of kinesiophobia 'Tampa Kinesiophobia Scale (TKS)' will be used. It is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury.
Satisfaction of the Treatment
Time frame: 4 weeks
An objective test that evaluates the satisfaction of the patient from pain status, functionality, treatment and physiotherapist after treatment will be assessed with 4 questions, and each question is given a score of 0-10 using the VAS scale. 0 means ''I am not satisfied at all'', 10 means ''I am very satisfied''.
Change in muscle strength from baseline to week 4
Time frame: 4 weeks
The muscle strength of shoulder flexion, abduction, adduction, external and internal rotation movements will be evaluated by using the Baseline Push-Pull (New York) dynamometer. Results will be calculated in kg (1 lb = 0.454 kg). The patient's arm will be stabilized and the patient will be asked to show maximum resistance within 2 sec against the dynamometer placed and then hold it for 5 seconds at this position and power. The measurement will be repeated twice and recorded with the average of these two values.
Change in disability of the fingers from baseline to week 4
Time frame: 4 weeks
The Nine-Hole Peg Test (9HPT) will be used to measure finger dexterity. The test is administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the test activity, recorded in seconds.
Change in spasticity from baseline to week 4
Time frame: 4 weeks
Spasticity will be defined with Modified Ashworth Scale (MAS). The MAS measures resistance during passive soft-tissue stretching. Scoring: 0= normal tone. 1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension. 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM. 2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3= considerable increase in muscle tone, passive movement difficult. 4= affected part(s) rigid in flexion or extension.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Background: PubMed 25206611Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
- Background: PubMed 30020092Arman N, Tarakci E, Tarakci D, Kasapcopur O. Effects of Video Games-Based Task-Oriented Activity Training (Xbox 360 Kinect) on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):174-181. doi: 10.1097/PHM.0000000000001001.
- Background: PubMed 14654886Burdea GC. Virtual rehabilitation--benefits and challenges. Methods Inf Med. 2003;42(5):519-23.
- Background: PubMed 12426529Rubin BD, Kibler WB. Fundamental principles of shoulder rehabilitation: conservative to postoperative management. Arthroscopy. 2002 Nov-Dec;18(9 Suppl 2):29-39. doi: 10.1053/jars.2002.36507. No abstract available.
- Background: PubMed 27190481Chen CC. Multimedia virtualized environment for shoulder pain rehabilitation. J Phys Ther Sci. 2016 Apr;28(4):1349-54. doi: 10.1589/jpts.28.1349. Epub 2016 Apr 28.
- Background: PubMed 8602410Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
- Background: PubMed 11371748Bjartmar C, Trapp BD. Axonal and neuronal degeneration in multiple sclerosis: mechanisms and functional consequences. Curr Opin Neurol. 2001 Jun;14(3):271-8. doi: 10.1097/00019052-200106000-00003.
- Background: PubMed 15596731Crayton H, Heyman RA, Rossman HS. A multimodal approach to managing the symptoms of multiple sclerosis. Neurology. 2004 Dec 14;63(11 Suppl 5):S12-8. doi: 10.1212/wnl.63.11_suppl_5.s12.
- Background: PubMed 22020457Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08.
- Background: PubMed 15716530Feys P, Helsen W, Liu X, Mooren D, Albrecht H, Nuttin B, Ketelaer P. Effects of peripheral cooling on intention tremor in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2005 Mar;76(3):373-9. doi: 10.1136/jnnp.2004.044305.
- Background: PubMed 1622300Hiller LB, Wade CK. Upper extremity functional assessment scales in children with Duchenne muscular dystrophy: a comparison. Arch Phys Med Rehabil. 1992 Jun;73(6):527-34.
- Background: PubMed 24640715Peresedova AV, Chernikova LA, Zavalishin IA. [Physical rehabilitation in multiple sclerosis: general principles and high-tech approaches]. Vestn Ross Akad Med Nauk. 2013;(10):14-21. Russian.
- Individual participant dataSharing planned: No
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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.
Halit Selcuk, MSc contact
Nimet Sermenli Aydın, MSc principal investigator
Marmara University Institute of Health Sciences
Dilara Merve Sari, MSc principal investigator
Marmara University Institute of Health Sciences
Zubeyir Sari, Assoc Prof study director
Marmara University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Based Virtual Reality Exercises and Conventional Physiotherapy and Rehabilitation in people with Rehabilitation and Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Nimet Sermenli Aydın, MSc (+905079955111, nimetsermenli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in range of motion from baseline to week 4 (time frame: 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212689, which also lists 12 linked publications.
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 4 Sep 2020.