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Clinical Trials/NCT06665607
NCT06665607
Recruiting
Not Applicable

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

Inés Llamas-Ramos1 site in 1 country34 target enrollmentStarted: November 4, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Inés Llamas-Ramos
Enrollment
34
Locations
1
Primary Endpoint
Four Square Step Test (FSST): dynamic stability assessment test.

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Four Square Step Test (FSST): dynamic stability assessment test.

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: Initial and after 8 weeks

Evaluate the patient´s perceived of balance confidence during 16 different daily activities. 0%-100%

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Inés Llamas-Ramos
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Inés Llamas-Ramos

PhD

University of Salamanca

Study Sites (1)

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