NCT06198972

Brief Summary

Multiple Sclerosis (MS) is an autoimmune, demyelinating disease that progresses with motor and sensory loss of the central nervous system and causes disability at different levels. Although signs and symptoms vary depending on the location of the lesion, findings such as loss of muscle strength, spasticity, sensory disorders and fatigue cause decreases in walking function in the majority of patients. Loss of muscle strength and fatigue cause loss of mobility, causing individuals with MS to be less physically active than healthy adults in the same age group. As a result, approximately 40% of individuals with MS have walking problems and approximately 70% of them experience a decrease in daily living activities. Literature studies frequently include strengthening exercises for lower extremity muscles in MS patients. However, the results of pelvic pattern exercises, which are the key to lower extremity movements, are not specified. In this study, which is planned in the light of this information, the findings obtained from pelvic PNF exercises will serve to fill this gap in the literature.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

December 27, 2023

Last Update Submit

April 14, 2025

Conditions

Keywords

PNFPelvic exercisestrength

Outcome Measures

Primary Outcomes (3)

  • Muscle Strength:

    Lower extremity muscle strength will be measured with a digital muscle dynamometer. Lower extremity muscles will be evaluated using a digital dynamometer (Knect). With this device, muscle force values are expressed in Newton (N). Muscle strength will be recorded by making 3 measurements with a digital dynamometer, on the right and left extremities, without allowing the patients to compensate, and the average values will be used.

    Baseline and after 6 weeks

  • Figure of 8 walk test

    It is a standard clinical measurement used to evaluate advanced walking performance required in daily life. In the figure-8 walking test, two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the beginning of the test, the child walks around the first cone as fast as he can, then when he reaches the other starting point, this time he walks around the other cone. The elapsed time is recorded. The validity and reliability of the figure-8 walking test was studied in stroke patients and knee prosthesis patients.

    Baseline and after 6 weeks

  • 12 ıtem walk test

    It is a 12-item questionnaire that questions the impact of walking on MS. The difficulties experienced by individuals during walking activity in the last 2 weeks are questioned. Each item contains 5 points (1; not at all impressed, 5; completely impressed). Lower scores indicate better gait impairment. It has been reported that the Turkish version of the scale is valid and reliable.

    Baseline and after 6 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

strength exercise training

Other: Strength exercises

Study Group

EXPERIMENTAL

pnf exercise training

Other: Pelvic Pnf exercises

Interventions

Exercise Frequency 3 days/week Exercise Intensity 60% of 1 maximum repetition Exercise Duration: 5-minute warm-up 20 minutes (2 sets of 15 repetitions) exercise training 5 min cool down Exercise Type Pelvic patterns * Anterior elevation-Posterior depression * Anterior depression-Posterior elevation PNF techniques * Repetitive stretching * Rhythmic stabilization

Study Group

3 days/week 60% of 1 repetition maximum 5 minute warm up 20 min exercise training 5 min cool down Lower extremity movements * Hip flexion * Hip extension * Hip abduction * Hip adduction * Knee flexion * Knee extension Resistance exercise training

Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Consent for the study was obtained;
  • Between 18-50 years of age,
  • Extended Disability Status Scale (EDSS) score of 4 and below,
  • Not in the habit of exercising regularly
  • Can walk on the treadmill,
  • Not pregnant,
  • Not receiving corticosteroid treatment in the last 1 month,
  • Fampridine etc. in the last month. not taking medication,
  • Patients who have not received Botox treatment in the last 6 months will be included.

You may not qualify if:

  • Individuals who cannot tolerate the treatment programs and cannot ensure their continuity (2 weeks in a row) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Islam Science and Technology University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Zekiye İpek Katırcı Kırmacı

    Gaziantep Islam Science and Technology University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 15, 2024

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations