Multiple SclerosisMS-PILATESNCT07800039
Clinical Pilates for Balance and Function in Multiple Sclerosis
A study testing Clinical Pilates-Based Rehabilitation and Conventional Exercise-Based Physiotherapy in people with Multiple Sclerosis, run by University of Patras at 1 site in Greece.
Trial summary
This randomized controlled trial evaluated the effects of an 8-week Clinical Pilates program on balance and physical function in individuals with multiple sclerosis (MS). Participants were randomly allocated to one of three groups: Clinical Pilates, conventional exercise-based physiotherapy, or a control group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Clinical Pilates-Based Rehabilitation and Conventional Exercise-Based Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGreece
- Study dates
- 30 May 2024to 10 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a diagnosis of multiple sclerosis
- Ability to maintain an upright standing position
- Mini-Mental State Examination (MMSE) score >24
Who cannot join
- Presence of neurological disorders other than multiple sclerosis
- Lower-limb and/or spinal surgery within the previous year
- History of heart failure
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Clinical Pilates Programme on Static and Dynamic Balance in Individuals With Multiple Sclerosis: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of an 8-week Clinical Pilates program on balance and physical function in individuals with multiple sclerosis (MS). Participants were randomly allocated to one of three groups: Clinical Pilates, conventional exercise-based physiotherapy, or a control group receiving postural guidance without a structured rehabilitation program. The two intervention groups completed 16 supervised exercise sessions over 8 weeks. Outcomes included static and dynamic balance, functional mobility, lower-limb motor function, fatigue, and exercise-related motivation. Assessments were conducted at baseline, after 4 and 8 weeks, and at a one-month follow-up.
- Conditions
- Multiple Sclerosis
- Being tested
- Clinical Pilates-Based Rehabilitation, Conventional Exercise-Based Physiotherapy
- Keywords
- Clinical Pilates, Physiotherapy, Balance, Postural Control, Rehabilitation, Functional Mobility
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pilates-Based RehabilitationBehavioural
Participants received an 8-week Clinical Pilates-based rehabilitation program comprising 16 sessions, delivered twice weekly with a minimum interval of 48 hours between sessions. Each session lasted approximately 60 minutes and included mobility and breathing exercises, strengthening, balance and coordination exercises, trunk control, core activation, body awareness, and stretching. Exercises were performed in standing, sitting, supine, prone, and side-lying positions. Exercise intensity and complexity were progressively adjusted according to individual ability.
Conventional Exercise-Based PhysiotherapyBehavioural
Participants received an 8-week conventional exercise-based physiotherapy program comprising 16 sessions, delivered twice weekly with a minimum interval of 48 hours between sessions. Each session lasted approximately 60 minutes and included progressive strengthening, postural control, sensory integration, balance, and functional training. Exercises progressed from stable to more demanding balance and functional activities, with difficulty individually adjusted according to each participant's abilities and performance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pilates | Experimental | Participants received an 8-week Clinical Pilates-based rehabilitation program consisting of 16 sessions (twice weekly), approximately 60 minutes per session. The program included mobility and breathing exercises, strengthening, balance and coordination exercises, trunk control, core activation, body awareness, and stretching, with progressive adjustment of exercise intensity and complexity. Receives: Behavioral: Clinical Pilates-Based Rehabilitation |
| Conventional Physiotherapy | Active comparator | Participants received an 8-week conventional exercise-based physiotherapy program consisting of 16 sessions (twice weekly), approximately 60 minutes per session. The program included progressive strengthening, postural control, sensory integration, balance, and functional training. Exercise difficulty was progressively adjusted according to each participant's individual capacity. Receives: Behavioral: Conventional Exercise-Based Physiotherapy |
| Control | No intervention | Participants did not receive a structured rehabilitation or exercise program during the study period. They received individualized guidance regarding postural control and balance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Center of Pressure Sway Area
Center of pressure (CoP) sway area was assessed using a Bertec force platform during six standing conditions: feet together with eyes open, feet together with eyes closed, single-leg stance on the right and left leg, and tandem stance with the right and left foot leading. CoP sway area was used as a measure of static postural control, with lower values indicating less postural sway.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Mini-BESTest Score
Dynamic balance was assessed using the Mini-Balance Evaluation Systems Test (Mini-BESTest), a 14-item clinical measure assessing anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The total score ranges from 0 to 28 points, with higher scores indicating better balance performance.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Secondary outcomes (6)
Change in Center of Pressure Displacement
Center of pressure (CoP) displacement in the mediolateral (ML) and anteroposterior (AP) directions was assessed using a Bertec force platform during six standing conditions: feet together with eyes open, feet together with eyes closed, single-leg stance on the right and left leg, and tandem stance with the right and left foot leading. Lower displacement values indicate less postural sway.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Functional Gait Assessment (FGA) Score
Dynamic balance during walking was assessed using the Functional Gait Assessment (FGA). The FGA consists of 10 items assessing the ability to modify gait while performing different walking tasks. Each item is scored from 0 to 3, giving a total score ranging from 0 to 30. Higher scores indicate better functional gait and dynamic balance.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Short Physical Performance Battery (SPPB) Score
Lower-limb physical performance was assessed using the Short Physical Performance Battery (SPPB), which includes standing balance, usual gait speed, and repeated chair-stand tests. Each component is scored from 0 to 4, giving a total score ranging from 0 to 12. Higher scores indicate better lower-limb physical performance.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Fugl-Meyer Assessment-Lower Extremity (FMA-LE) Domain Scores
Lower-limb sensorimotor function was assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE). The following domains were analyzed separately: lower-extremity motor function (E-F; score range: 0-34), sensation (H; score range: 0-12), passive joint motion (I; score range: 0-20), and joint pain (J; score range: 0-20). Higher scores indicate better motor and sensory function, greater passive joint mobility, and less joint pain, respectively.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Fatigue Severity Scale (FSS) Score
Fatigue was assessed using the Fatigue Severity Scale (FSS), a 9-item questionnaire evaluating the severity and impact of fatigue on daily functioning. Each item is rated from 1 to 7, with higher scores indicating greater fatigue severity.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Intrinsic Motivation Inventory (IMI) Scores
Exercise-related motivation was assessed using the 22-item version of the Intrinsic Motivation Inventory (IMI), comprising four subscales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. Items are rated on a 7-point scale from 1 (not at all true) to 7 (very true), with negatively worded items reverse-scored. Subscale scores are calculated by averaging the corresponding item scores and therefore range from 1 to 7. Higher scores indicate greater levels of the construct represented by each subscale (i.e., greater interest/enjoyment, perceived competence, perceived choice, or pressure/tension). The IMI was administered only to participants in the two intervention groups.
Measured: 2nd, 5th and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start30 May 2024
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
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.
- 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
- Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: Clinical Pilates, conventional exercise-based physiotherapy, or control.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Lampropoulou, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800039
- Sponsor's protocol ID
- UPAT-MS-PILATES-2024
- Acronym
- MS-PILATES
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Clinical Pilates Programme on Static and Dynamic Balance in Individuals With Multiple Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07800039
- Acronym / sponsor ID
- MS-PILATES / UPAT-MS-PILATES-2024
- Conditions
- Multiple Sclerosis
- Keywords
- Clinical Pilates, Physiotherapy, Balance, Postural Control, Rehabilitation, Functional Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 2 Sep 2026 (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.
This randomized controlled trial evaluated the effects of an 8-week Clinical Pilates program on balance and physical function in individuals with multiple sclerosis (MS). Participants were randomly allocated to one of three groups: Clinical Pilates, conventional exercise-based physiotherapy, or a control group receiving postural guidance without a structured rehabilitation program. The two intervention groups completed 16 supervised exercise sessions over 8 weeks. Outcomes included static and dynamic balance, functional mobility, lower-limb motor function, fatigue, and exercise-related motivation. Assessments were conducted at baseline, after 4 and 8 weeks, and at a one-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: Clinical Pilates, conventional exercise-based physiotherapy, or control.
| Arm | Type | Receives |
|---|---|---|
| Clinical Pilates | Experimental | Behavioral: Clinical Pilates-Based RehabilitationParticipants received an 8-week Clinical Pilates-based rehabilitation program consisting of 16 sessions (twice weekly), approximately 60 minutes per session. The program included mobility and breathing exercises, strengthening, balance and coordination exercises, trunk control, core activation, body awareness, and stretching, with progressive adjustment of exercise intensity and complexity. |
| Conventional Physiotherapy | Active comparator | Behavioral: Conventional Exercise-Based PhysiotherapyParticipants received an 8-week conventional exercise-based physiotherapy program consisting of 16 sessions (twice weekly), approximately 60 minutes per session. The program included progressive strengthening, postural control, sensory integration, balance, and functional training. Exercise difficulty was progressively adjusted according to each participant's individual capacity. |
| Control | No intervention | –Participants did not receive a structured rehabilitation or exercise program during the study period. They received individualized guidance regarding postural control and balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with a diagnosis of multiple sclerosis
- Ability to maintain an upright standing position
- Mini-Mental State Examination (MMSE) score >24
Key exclusion criteria (4 listed)
- Presence of neurological disorders other than multiple sclerosis
- Lower-limb and/or spinal surgery within the previous year
- History of heart failure
- Uncontrolled hypertension
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 |
|---|---|---|
| Clinical Pilates-Based RehabilitationParticipants received an 8-week Clinical Pilates-based rehabilitation program comprising 16 sessions, delivered twice weekly with a minimum interval of 48 hours between sessions. Each session lasted approximately 60 minutes and included mobility and breathing exercises, strengthening, balance and coordination exercises, trunk control, core activation, body awareness, and stretching. Exercises were performed in standing, sitting, supine, prone, and side-lying positions. Exercise intensity and complexity were progressively adjusted according to individual ability. | Behavioural | Clinical Pilates |
| Conventional Exercise-Based PhysiotherapyParticipants received an 8-week conventional exercise-based physiotherapy program comprising 16 sessions, delivered twice weekly with a minimum interval of 48 hours between sessions. Each session lasted approximately 60 minutes and included progressive strengthening, postural control, sensory integration, balance, and functional training. Exercises progressed from stable to more demanding balance and functional activities, with difficulty individually adjusted according to each participant's abilities and performance. | Behavioural | Conventional Physiotherapy |
Primary outcome
Change in Center of Pressure Sway Area
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Center of pressure (CoP) sway area was assessed using a Bertec force platform during six standing conditions: feet together with eyes open, feet together with eyes closed, single-leg stance on the right and left leg, and tandem stance with the right and left foot leading. CoP sway area was used as a measure of static postural control, with lower values indicating less postural sway.
Change in Mini-BESTest Score
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Dynamic balance was assessed using the Mini-Balance Evaluation Systems Test (Mini-BESTest), a 14-item clinical measure assessing anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The total score ranges from 0 to 28 points, with higher scores indicating better balance performance.
6 secondary outcomes
Change in Center of Pressure Displacement
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Functional Gait Assessment (FGA) Score
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Fugl-Meyer Assessment-Lower Extremity (FMA-LE) Domain Scores
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Change in Fatigue Severity Scale (FSS) Score
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Intrinsic Motivation Inventory (IMI) Scores
Time frame: 2nd, 5th and 8th week
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 9 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pilates-Based Rehabilitation and Conventional Exercise-Based Physiotherapy in people with Multiple Sclerosis, run by University of Patras at 1 site in Greece.
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 4 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 9 Sep 2026. 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 Greece. 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?
Change in Center of Pressure Sway Area (time frame: Baseline, Week 4, Week 8, and 1-month follow-up). The study lists 2 primary outcomes in all. 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 9 Sep 2026.