Foot Muscles Training in Sclerosis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Muscle Weakness; Training Group, Sensitivity

• Registration Number: NCT06665607
• Lead Sponsor: Inés Llamas-Ramos

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-11-01
• Study Start: 2024-11-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Four Square Step Test (FSST): dynamic stability assessment test.	Initial and after 8 weeks	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.
Six Spot Step Test (SSST): test that quantitatively assesses lower limb function	Initial and after 8 weeks	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.
The Frailty and Injuries: Cooperative Studies of Intervention Tecnhiques (FICSIT-4 test): Test of static balance	0-9 points. Initial and after 8 weeks	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.
Activities-specific Balance Confidence scale (AsBC)	Initial and after 8 weeks	Evaluate the patient´s perceived of balance confidence during 16 different daily activities. 0%-100%

Trial Locations

Locations (1)

Universidad de Valladolid; 🇪🇸 Valladolid, Spain