Multiple SclerosisNCT04838886
The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients
A study testing Telerehabilitation-based Pilates Exercise in people with Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated… 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?
- Telerehabilitation-based Pilates Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 25 May 2022
- 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
- 18-65 years of age
- Voluntarily participate in research to accept
- Having a diagnosis of "Multiple Sclerosis" by a specialist physician
- Relapse free in the last 3 mounts
- An Expanded Disability Status Scale (EDSS) score less than or equal to 4
Who cannot join
- Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara
About this study
Official title: The Effect of Telerehabilitation Based Pilates Training on Physical Performance and Quality of Life in Multiple Sclerosis Patients
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. In MS, various loss of strength, balance, fatigue, cognitive and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders affect the quality of life by limiting the individual's activities and participation in their daily lives. Therefore, it is important to treat these disorders in the treatment of MS.
There are various pharmacological treatments and invasive procedures for the management of MS symptoms and one of the most commonly used treatment options is rehabilitation. Clinically-based exercise and rehabilitation are some of the most beneficial rehabilitation strategies in people with MS (PwMS). Clinically-based exercise and rehabilitation have been shown to stabilize or improve many physical symptoms of MS including loss of strength, balance dysfunction, impaired mobility, and fatigue. These benefits have led many practitioners to consider physical exercise as a nonpharmaceutical disease-modifying treatment. However, due to various factors such as mobility disorders, fatigue, and related problems, geographic location, time constraints, transportation difficulties, health insurance coverage, and financial burden, clinical-based exercise may be problematic in some pwMS. To overcome these challenges, approaches to rehabilitation have been developed such as telerehabilitation. The telerehabilitation system provides benefits such as continuity in patient education and rehabilitation, showing progress in rehabilitation, making changes in the treatment program, and saving individuals time and financial expenses. It is also an innovative and potential alternative to face-to-face interventions for treating disease-related disorders in pwMS. In literature, there are many studies examining the effectiveness of telerehabilitation in pwMS. According to these studies, ıt has been shown that telerehabilitation, with its technical facilities, had the potential to make clinical interventions widely accessible and effective for MS, however, telerehabilitation-based interventions could not replace traditional interventions but could perfectly complement. It has been found that telerehabilitation improved balance and postural control in MS patients and had no side effects. However, it was emphasized that the evidence levels of the studies were insufficient for methodological reasons. It has been determined additional studies are needed to investigate examining the effect on walking.
Read more
Another clinical-based exercise method is Pilates. Pilates is a "core" stability-based exercise method that includes endurance, flexibility, movement, posture, and respiratory control. Studies have shown that Pilates training can improve balance, mobility, and muscle strength, fatigue in pwMS due to its structure consisting of balance and strengthening exercises. When the literature is reviewed in terms of Telerehabilitation based on Pilates in pwMS, it is seen that there are only two studies. In both studies, pwMS were given 20 minutes of yoga, 20 minutes of Pilates, and 20 minutes of dual-task exercise. However, these studies were in the project phase and the results are still not reported. On the other hand, in both studies, Pilates is given as combined training.
As a result, telerehabilitation is an alternative method to MS treatment. In addition, while there are many clinical-based Pilates studies in the literature, telerehabilitation-based Pilates studies are insufficient. Telerehabilitation-based Pilates training studies are needed. Therefore, the investigators planned this study to investigate the effect of telerehabilitation-based pilates training on physical performance and quality of life in pwMS.
Read the detailed description
This study is planned as a randomized control trial. Patients will be randomly divided into two groups as intervention and control. The intervention group will be received telerehabilitation-based pilates training three times a week for six weeks. Telerehabilitation-based pilates will be provided via videoconferencing.
The first session will be the introduction session, patients will be informed about basic principles of Pilates and it will be included teaching inward movement of the lower abdominal wall and supine exercises of segmental movements involving trunk muscle recruitment to maintain a neutral posture. Afterward the session, a typical session will be included supine, side-lying, quadruped exercise, sitting on the exercise ball, and standing exercises. Exercises will be included thoracic extension, general abdominal strengthening, core stabilization exercises for the deep abdominal muscles. The difficulty of these exercises will be gradually increased and focused on keeping neutral positions of the spine in different gravity orientations. The control group will be a wait-list group without any additional specific treatment. All assessments will be done before and after the 6-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken and the Expanded Disability Status Scale score of those of MS will be recorded. Primary outcomes are balance, gait, core endurance and power, and muscle strength; secondary outcomes are physical activity, fatigue, and quality of life
- Conditions
- Multiple Sclerosis
- Being tested
- Telerehabilitation-based Pilates Exercise
- Keywords
- Multiple Sclerosis, Pilates, Exercise, Telerehabilitation, Physical performance, Balance, Gait, Fatigue
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation-based Pilates ExerciseOther
The group that will receive telerehabilitation-based pilates training via telerehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The intervention group will be received telerehabilitation-based pilates training three times a week for 6 weeks. Receives: Other: Telerehabilitation-based Pilates Exercise |
| Waitlist | No intervention | The control group will be a wait-list group without any additional specific treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance- Baseline
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Measured: Assessment will be conducted before the intervention
Dynamic Balance-Post intervention
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Measured: Assessment will be conducted immediately after the intervention.
Static Balance- Baseline
Biodex Balance System
Measured: Assessment will be conducted before the intervention.
Static Balance- Post intervention
Biodex Balance System
Measured: Assessment will be conducted immediately after the intervention.
An individual's confidence in performing activities- Baseline
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
Measured: Assessment will be conducted before the intervention.
An individual's confidence in performing activities- Post intervention
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
Measured: Assessment will be conducted immediately after the intervention.
Exercise capacity- Baseline
Six minute walk test
Measured: Assessment will be conducted before the intervention.
Exercise capacity- Post intervention
Six minute walk test
Measured: Assessment will be conducted immediately after the intervention.
Gait parameters- Baseline
Wearable system (G-Walk)
Measured: Assessment will be conducted before the intervention.
Gait parameters- Post intervention
Wearable system (G-Walk)
Measured: Assessment will be conducted immediately after the intervention.
Functional mobility- Baseline
Timed up go test
Measured: Assessment will be conducted before the intervention.
Functional mobility- Post intervention
Timed up go test
Measured: Assessment will be conducted immediately after the intervention.
Core endurance- Baseline
Mcgill core endurance tests
Measured: Assessment will be conducted before the intervention.
Core endurance- Post intervention
Mcgill core endurance tests
Measured: Assessment will be conducted immediately after the intervention.
Core strength- Baseline
Mcgill core strength tests
Measured: Assessment will be conducted before the intervention.
Core strength-Post intervention
Mcgill core strength tests
Measured: Assessment will be conducted immediately after the intervention.
Muscle Strength outcomes- Baseline
Hand dynamometer (Baseline®, White Plains, New York, US)
Measured: Assessment will be conducted before the intervention.
Muscle Strength outcomes- Post intervention
Hand dynamometer (Baseline®, White Plains, New York, US)
Measured: Assessment will be conducted immediately after the intervention.
Secondary outcomes (8)
Physical activity level- Baseline
international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best)
Measured: Assessment will be conducted before the intervention.
Physical activity level- Post intervention
international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best)
Measured: Assessment will be conducted immediately after the intervention.
Fatigue severity- Baseline
Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst)
Measured: Assessment will be conducted before the intervention.
Fatigue severity- Post intervention
Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst)
Measured: Assessment will be conducted immediately after the intervention.
Impact of fatigue on activities- Baseline
Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst)
Measured: Assessment will be conducted before the intervention.
Impact of fatigue on activities- Post intervention
Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst)
Measured: Assessment will be conducted immediately after the intervention.
Health related quality of life- Baseline
Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best)
Measured: Assessment will be conducted before the intervention.
Health related quality of life- Post intervention- Post intervention
Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best)
Measured: Assessment will be conducted immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Apr 2021
- Primary completion15 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Model description
- Intervention and control groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kader Eldemir, Gazi University
- Investigators
- Kader Eldemir, PT, MSc., Study chair, Research AssistantArzu Güçlü-Gündüz, PT, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838886
- Sponsor's protocol ID
- Gazi 2
- Status last verified
- May 2022
- First submitted
- 30 Mar 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data but when the statistical analysis of all data are made, all results will be shared
Publications
Eldemir K, Guclu-Gunduz A, Eldemir S, Saygili F, Ozkul C, Irkec C. Effects of Pilates-based telerehabilitation on physical performance and quality of life in patients with multiple sclerosis. Disabil Rehabil. 2024 May;46(9):1807-1814. doi: 10.1080/09638288.2023.2205174. Epub 2023 May 6.
PubMed 37147864
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation Based Pilates Training on Physical Performance and Quality of Life in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04838886
- Acronym / sponsor ID
- Gazi 2
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Pilates, Exercise, Telerehabilitation, Physical performance, Balance, Gait, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 9 Apr 2021 (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.
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. In MS, various loss of strength, balance, fatigue, cognitive and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders affect the quality of life by limiting the individual's activities and participation in their daily lives. Therefore, it is important to treat these disorders in the treatment of MS.
There are various pharmacological treatments and invasive procedures for the management of MS symptoms and one of the most commonly used treatment options is rehabilitation. Clinically-based exercise and rehabilitation are some of the most beneficial rehabilitation strategies in people with MS (PwMS). Clinically-based exercise and rehabilitation have been shown to stabilize or improve many physical symptoms of MS including loss of strength, balance dysfunction, impaired mobility, and fatigue. These benefits have led many practitioners to consider physical exercise as a nonpharmaceutical disease-modifying treatment. However, due to various factors such as mobility disorders, fatigue, and related problems, geographic location, time constraints, transportation difficulties, health insurance coverage, and financial burden, clinical-based exercise may be problematic in some pwMS. To overcome these challenges, approaches to rehabilitation have been developed such as telerehabilitation. The telerehabilitation system provides benefits such as continuity in patient education and rehabilitation, showing progress in rehabilitation, making changes in the treatment program, and saving individuals time and financial expenses. It is also an innovative and potential alternative to face-to-face interventions for treating disease-related disorders in pwMS. In literature, there are many studies examining the effectiveness of telerehabilitation in pwMS. According to these studies, ıt has been shown that telerehabilitation, with its technical facilities, had the potential to make clinical interventions widely accessible and effective for MS, however, telerehabilitation-based interventions could not replace traditional interventions but could perfectly complement. It has been found that telerehabilitation improved balance and postural control in MS patients and had no side effects. However, it was emphasized that the evidence levels of the studies were insufficient for methodological reasons. It has been determined additional studies are needed to investigate examining the effect on walking.
Another clinical-based exercise method is Pilates. Pilates is a "core" stability-based exercise method that includes endurance, flexibility, movement, posture, and respiratory control. Studies have shown that Pilates training can improve balance, mobility, and muscle strength, fatigue in pwMS due to its structure consisting of balance and strengthening exercises. When the literature is reviewed in terms of Telerehabilitation based on Pilates in pwMS, it is seen that there are only two studies. In both studies, pwMS were given 20 minutes of yoga, 20 minutes of Pilates, and 20 minutes of dual-task exercise. However, these studies were in the project phase and the results are still not reported. On the other hand, in both studies, Pilates is given as combined training.
As a result, telerehabilitation is an alternative method to MS treatment. In addition, while there are many clinical-based Pilates studies in the literature, telerehabilitation-based Pilates studies are insufficient. Telerehabilitation-based Pilates training studies are needed. Therefore, the investigators planned this study to investigate the effect of telerehabilitation-based pilates training on physical performance and quality of life in pwMS.
Detailed description
This study is planned as a randomized control trial. Patients will be randomly divided into two groups as intervention and control. The intervention group will be received telerehabilitation-based pilates training three times a week for six weeks. Telerehabilitation-based pilates will be provided via videoconferencing.
The first session will be the introduction session, patients will be informed about basic principles of Pilates and it will be included teaching inward movement of the lower abdominal wall and supine exercises of segmental movements involving trunk muscle recruitment to maintain a neutral posture. Afterward the session, a typical session will be included supine, side-lying, quadruped exercise, sitting on the exercise ball, and standing exercises. Exercises will be included thoracic extension, general abdominal strengthening, core stabilization exercises for the deep abdominal muscles. The difficulty of these exercises will be gradually increased and focused on keeping neutral positions of the spine in different gravity orientations. The control group will be a wait-list group without any additional specific treatment. All assessments will be done before and after the 6-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken and the Expanded Disability Status Scale score of those of MS will be recorded. Primary outcomes are balance, gait, core endurance and power, and muscle strength; secondary outcomes are physical activity, fatigue, and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention and control groups
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Telerehabilitation-based Pilates ExerciseThe intervention group will be received telerehabilitation-based pilates training three times a week for 6 weeks. |
| Waitlist | No intervention | –The control group will be a wait-list group without any additional specific treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years of age
- Voluntarily participate in research to accept
- Having a diagnosis of "Multiple Sclerosis" by a specialist physician
- Relapse free in the last 3 mounts
- An Expanded Disability Status Scale (EDSS) score less than or equal to 4
Key exclusion criteria (1 listed)
- Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.
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 |
|---|---|---|
| Telerehabilitation-based Pilates ExerciseThe group that will receive telerehabilitation-based pilates training via telerehabilitation | Other | Exercise group |
Primary outcome
Dynamic Balance- Baseline
Time frame: Assessment will be conducted before the intervention
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Dynamic Balance-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Static Balance- Baseline
Time frame: Assessment will be conducted before the intervention.
Biodex Balance System
Static Balance- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Biodex Balance System
An individual's confidence in performing activities- Baseline
Time frame: Assessment will be conducted before the intervention.
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
An individual's confidence in performing activities- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
Exercise capacity- Baseline
Time frame: Assessment will be conducted before the intervention.
Six minute walk test
Exercise capacity- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Six minute walk test
Gait parameters- Baseline
Time frame: Assessment will be conducted before the intervention.
Wearable system (G-Walk)
Gait parameters- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Wearable system (G-Walk)
Functional mobility- Baseline
Time frame: Assessment will be conducted before the intervention.
Timed up go test
Functional mobility- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Timed up go test
Core endurance- Baseline
Time frame: Assessment will be conducted before the intervention.
Mcgill core endurance tests
Core endurance- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Mcgill core endurance tests
Core strength- Baseline
Time frame: Assessment will be conducted before the intervention.
Mcgill core strength tests
Core strength-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Mcgill core strength tests
Muscle Strength outcomes- Baseline
Time frame: Assessment will be conducted before the intervention.
Hand dynamometer (Baseline®, White Plains, New York, US)
Muscle Strength outcomes- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Hand dynamometer (Baseline®, White Plains, New York, US)
8 secondary outcomes
Physical activity level- Baseline
Time frame: Assessment will be conducted before the intervention.
Physical activity level- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Fatigue severity- Baseline
Time frame: Assessment will be conducted before the intervention.
Fatigue severity- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Impact of fatigue on activities- Baseline
Time frame: Assessment will be conducted before the intervention.
Impact of fatigue on activities- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Health related quality of life- Baseline
Time frame: Assessment will be conducted before the intervention.
Health related quality of life- Post intervention- Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 37147864Eldemir K, Guclu-Gunduz A, Eldemir S, Saygili F, Ozkul C, Irkec C. Effects of Pilates-based telerehabilitation on physical performance and quality of life in patients with multiple sclerosis. Disabil Rehabil. 2024 May;46(9):1807-1814. doi: 10.1080/09638288.2023.2205174. Epub 2023 May 6.
- related infoLink provided by the sponsor.
- related infoLink provided by the sponsor.
- related infoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data but when the statistical analysis of all data are made, all results will be shared
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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.
Kader Eldemir, PT, MSc. study chair
Research Assistant
Arzu Güçlü-Gündüz, PT, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation-based Pilates Exercise in people with Multiple Sclerosis, run by Gazi 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 27 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dynamic Balance- Baseline (time frame: Assessment will be conducted before the intervention). The study lists 18 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 NCT04838886, which also lists 1 linked publication.
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 27 May 2022.