Clinical Pilates for Balance and Function in Multiple Sclerosis

NCT07800039 | Completed

• 1 other identifier: UPAT-MS-PILATES-2024
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Clinical Pilates; Physiotherapy; Balance; Postural Control; Rehabilitation; Functional Mobility

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 4, Week 8, and 1-month follow-up

Secondary Outcomes (6)

• Change in Center of Pressure Displacement

  Baseline, Week 4, Week 8, and 1-month follow-up

• Change in Functional Gait Assessment (FGA) Score

  Baseline, Week 4, Week 8, and 1-month follow-up

• Change in Short Physical Performance Battery (SPPB) Score

  Baseline, Week 4, Week 8, and 1-month follow-up

• Change in Fugl-Meyer Assessment-Lower Extremity (FMA-LE) Domain Scores

  Baseline, Week 4, Week 8, and 1-month follow-up

• Change in Fatigue Severity Scale (FSS) Score

  Baseline, Week 4, Week 8, and 1-month follow-up

Study Arms (3)

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.

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.

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.

Interventions

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.

Conventional Physiotherapy

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.

Clinical Pilates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Home-Based Study Site

Ioannina, Epirus, Greece

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigator remained blinded to participants' group allocation during data analysis. Participant data were coded and analyzed without access to identifying information or knowledge of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Physiotherapy

Model Details: Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: Clinical Pilates, conventional exercise-based physiotherapy, or control.

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 2, 2026
• Study Start: May 30, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)