Foot Muscles Training in Sclerosis

Effects of Intrinsic Foot Muscles Training in Improving Stability in Multiple Sclerosis Patients

The study tries to assess the efficacy of an 8-week IFM training programme on stability in patients diagnosed with Multiple Sclerosis

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Muscle Weakness; Training Group, Sensitivity
• Intervention / Treatment: Procedure: Intrinsic Mucle Training

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel García García, PhD; Phone Number: 620712485; Email: daniel.ggarcia@uva.es
• Study Contact Backup: Name: Inés Llamas Ramos, PhD; Phone Number: 663005052; Email: inesllamas@usal.es

Study Locations

• Spain
  • Valladolid, Spain
    • Recruiting
    • Universidad de Valladolid
    • Contact: Daniel García García, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with moderate neurological disability as scored by the Expanded Disability Status Scale (EDSS), ranging from 3.0 to 6.0

Exclusion Criteria:

• Cognitive disturbances that could affect the performance of any of the tests or questionnaires included in the study
• Diagnosis of visual or vestibular disorders that could affect patient stability
• Change in Multiple Sclerosis-specific medication in the 2 months prior to the start of the study
• Acute relapse in the 2 months prior to the start of the study
• Traumatologic or orthopaedic disorders that could negatively affect balance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training Group	Procedure: Intrinsic Mucle Training; Conventional physiotherapy treatment and the intrinisc foot muscles strengthening program for 8 weeks.
Sham Comparator: Control Group	Procedure: Intrinsic Mucle Training; Conventional physiotherapy treatment and the intrinisc foot muscles strengthening program for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Four Square Step Test (FSST): dynamic stability assessment test.	The test consists of drawing a cross on the floor, delimiting 4 squares. The subject is placed in square number 1 in front of square number 2. The objective is to enter as quickly as possible into each square following the following sequence: Square number 1, 2, 3, 4, 1, 4, 4, 3, 2 and 1. It measures time.	Initial and after 8 weeks
Six Spot Step Test (SSST): test that quantitatively assesses lower limb function	The test field measured one meter (width) by five meters (length). In the middle of the width line (0.50 m), a cone was placed in the proximal and distal areas of the line (start point and finish point). On each lateral line, two cones were placed at distances of one and three meters on the left. Another two cones were placed at two and four meters on the right. The subjects were instructed to walk on alternating sides and to kick the cones, alternating between the medial and lateral sides of the same foot. The subjects were instructed to complete the test as quickly as possible, without running. It measures distance.	Initial and after 8 weeks
The Frailty and Injuries: Cooperative Studies of Intervention Tecnhiques (FICSIT-4 test): Test of static balance	Participants have to maintain four progressively difficult foot positions for 10 seconds each (side by side stance, semi-tandem stance, tanden stance, unipedal stance). It measures the ability to maintain posture without losing balance is evaluated.	0-9 points. Initial and after 8 weeks
Activities-specific Balance Confidence scale (AsBC)	Evaluate the patient´s perceived of balance confidence during 16 different daily activities. 0%-100%	Initial and after 8 weeks

Collaborators and Investigators

• Sponsor: Inés Llamas-Ramos

Study record dates

Study Major Dates

• Study Start (Estimated): November 4, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Muscle Weakness
• Other Study ID Numbers: FOOT TRAINING-SCLEROSIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No