Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06665607

Effects of Intrinsic Foot Muscles Training on Stability in Patients with Multiple Sclerosis

Led by Inés Llamas-Ramos · Updated on 2024-11-01

34

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of an 8-week intrinsic foot muscles (IFM) training program on improving stability in patients with Multiple Sclerosis who have moderate neurological disability. The study aims to assess how this specific foot muscle training may impact balance and lower limb function in this population. Participants are randomly assigned to one of two groups: a training group that receives conventional physiotherapy combined with the IFM strengthening program, and a control group that receives sham treatment. The intervention lasts for 8 weeks, focusing on enhancing foot muscle strength to potentially improve stability. Participants will undergo several assessments at the start and after 8 weeks, including the Four Square Step Test (FSST) for dynamic stability, the Six Spot Step Test (SSST) for lower limb function, the FICSIT-4 test for static balance, and the Activities-specific Balance Confidence scale (AsBC). These tests help measure changes in stability and confidence related to balance. The study includes triple masking to reduce bias during the randomized trial period.

CONDITIONS

Brief Title

Foot Muscles Training in Sclerosis

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with moderate neurological disability as scored by the Expanded Disability Status Scale (EDSS), ranging from 3.0 to 6.0
  • Age between 18 and 70 years
  • Diagnosis of Multiple Sclerosis
Not Eligible

You will not qualify if you...

  • Cognitive disturbances affecting test or questionnaire performance
  • Diagnosis of visual or vestibular disorders affecting stability
  • Change in Multiple Sclerosis-specific medication in the 2 months prior to study start
  • Acute relapse within 2 months before study start
  • Traumatologic or orthopedic disorders negatively impacting balance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants undergo conventional physiotherapy treatment combined with intrinsic foot muscles strengthening program.

1 baseline visit and 1 follow-up visit after 8 weeks

Trial Site Locations

Total: 1 location

1

Universidad de Valladolid

Valladolid, Spain

Actively Recruiting

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Research Team

D

Daniel García García, PhD

I

Inés Llamas Ramos, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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