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Foot Muscles Training in Sclerosis

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06665607
Enrollment
34
Registered
2024-10-30
Start date
2024-11-04
Completion date
2025-07-15
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Muscle Weakness, Training Group, Sensitivity

Brief summary

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

Interventions

PROCEDUREIntrinsic Mucle Training

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

Sponsors

Inés Llamas-Ramos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Four Square Step Test (FSST): dynamic stability assessment test.Initial and after 8 weeksThe 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 functionInitial and after 8 weeksThe 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 balance0-9 points. Initial and after 8 weeksParticipants 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 weeksEvaluate the patient´s perceived of balance confidence during 16 different daily activities. 0%-100%

Countries

Spain

Contacts

Primary ContactDaniel García García, PhD
daniel.ggarcia@uva.es620712485
Backup ContactInés Llamas Ramos, PhD
inesllamas@usal.es663005052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026