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Recruiting

NCT Number: NCT06665607

Foot Muscles Training in Sclerosis

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrinsic Mucle Training

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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%

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel García García, PhD

CONTACT

[email protected]

620712485

Inés Llamas Ramos, PhD

CONTACT

[email protected]

663005052

Sponsors and collaborators

Lead sponsor

Inés Llamas-Ramos

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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