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NCT Number: NCT07800039

Clinical Pilates for Balance and Function in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Home-Based Study Site

Ioannina, Epirus, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with a diagnosis of multiple sclerosis
  • Ability to maintain an upright standing position
  • Mini-Mental State Examination (MMSE) score >24

Exclusion criteria

  • Presence of neurological disorders other than multiple sclerosis
  • Lower-limb and/or spinal surgery within the previous year
  • History of heart failure
  • Uncontrolled hypertension

Treatment and study plan

Clinical Pilates-Based Rehabilitation

Behavioral

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 Physiotherapy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Center of Pressure Displacement

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    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.

  2. Change in Functional Gait Assessment (FGA) Score

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    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.

  3. Change in Short Physical Performance Battery (SPPB) Score

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    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.

  4. Change in Fugl-Meyer Assessment-Lower Extremity (FMA-LE) Score

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    Lower-limb sensorimotor function was assessed using the lower-extremity section of the Fugl-Meyer Assessment (FMA-LE). The assessment evaluates lower-limb motor function, sensation, joint range of motion, and joint pain. Higher scores indicate better lower-limb sensorimotor function.

  5. Change in Fatigue Severity Scale (FSS) Score

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    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.

  6. Change in Intrinsic Motivation Inventory (IMI) Scores

    Time frame: 2nd, 5th and 8th week

    Exercise-related motivation was assessed using selected subscales of the Intrinsic Motivation Inventory (IMI), including interest/enjoyment, perceived competence, perceived choice, and pressure/tension. The IMI was administered only to participants in the two intervention groups. Higher scores reflect greater levels of the construct assessed by each subscale.

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

Effectiveness of a Clinical Pilates Programme on Static and Dynamic Balance in Individuals With Multiple Sclerosis: A Randomized Controlled Trial

Acronym: MS-PILATES

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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