Foot Muscles Training in Sclerosis

NCT06665607 | Recruiting

• 1 other identifier: FOOT TRAINING-SCLEROSIS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; Muscle Weakness; Training Group, Sensitivity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Training Group

EXPERIMENTAL

Procedure: Intrinsic Mucle Training

Control Group

SHAM COMPARATOR

Procedure: Intrinsic Mucle Training

Interventions

Intrinsic Mucle Training PROCEDURE

Conventional physiotherapy treatment and the intrinisc foot muscles strengthening program for 8 weeks.

Control Group; Training Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inés Llamas-Ramos: lead

Study Sites (1)

Universidad de Valladolid

Valladolid, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Weakness; Hypersensitivity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Daniel García García, PhD

CONTACT

620712485; daniel.ggarcia@uva.es

Inés Llamas Ramos, PhD

CONTACT

663005052; inesllamas@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: November 4, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 15, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)