Foot Muscles Training in Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInés Llamas-Ramos

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrinsic Mucle Training

    Procedure/Surgery

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Training GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Initial and after 8 weeks
2

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.

Time frame
Initial and after 8 weeks
3

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.

Time frame
0-9 points. Initial and after 8 weeks
4

Activities-specific Balance Confidence scale (AsBC)

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

Time frame
Initial and after 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inés Llamas-Ramos

Lead sponsor

University of Salamanca

Sponsor institution