Effects of Lower Extremity Neuromuscular Facilitation and Patients With Multiple Sclerosis

Effects of Lower Extremity Neuromuscular Facilitation on Gait, Balance and Fatigue in Patients With Multiple Sclerosis: A Randomized Controlled Study

Objective: This study aimed to investigate the effects of lower extremity Proprioceptive Neuromuscular Facilitation (PNF) exercises on balance, gait, and fatigue in patients with Multiple Sclerosis (MS).

Method: Twenty-six MS patients (18 women, 8 men) were included in the study. Participants were divided into two groups. The study group (n=13) underwent lower extremity Proprioceptive Neuromuscular Facilitation exercises, while the control group (n=13) underwent lower extremity strengthening exercise training three days a week for six weeks. Static balance, tandem stance test, dynamic balance, walking with the 4-step square test, walking with the 25-step test, and fatigue were assessed twice, before and after treatment, using the fatigue severity scale.

Study Overview

• Status: Completed
• Conditions: Fatigue Syndrome, Chronic; Balance; Gait Balance
• Intervention / Treatment: Other: exercises

Detailed Description

This study was conducted as a randomised, parallel-group, single-blind clinical trial in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Guidelines. Ethical approval was obtained from the SANKO University Non-Interventional Clinical Research Ethics Committee (2024/11-5).

MS patients who volunteered from the SANKO University Faculty of Medicine Neurology Clinic were included in the study. Inclusion criteria were (i) diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) according to the 2017 McDonald criteria, (ii) age 18-65, (iii) Expanded Disability Status Scale (EDSS) score of 4 or below, (iv) no relapse in the last 6 months. Exclusion criteria were (i) a history of lower extremity trauma within the last year, (ii) a history of known chronic neurological disorders, (iii) any contraindication to exercise, and (iv) cognitive impairment as defined by a mini-mental test (score below 24).

The required sample size for the study was determined using a power analysis performed with the G-Power 3.1* programme. The analysis resulted in a medium effect size for between-group comparisons at a 5% significance level (Type I error probability, α=0.05) and 85% statistical power (1-β=0.85), at least 11 participants were needed in each group to detect a medium effect size (Cohen's d ≈ 0.5) in between-group comparisons. A total of 26 participants, 13 in each of the Experimental and Control groups, were included in the study, and this number met the minimum sample size determined by the power analysis.

Forty patients diagnosed with MS were invited to participate in the study, but those who voluntarily withdrew or never started the study (n = 14) were excluded. The study was completed with 26 patients: 13 in the Study group (nine women, four men) and 13 in the Control group (nine women, four men). A minimisation method was used to balance the gender and clinical course of the participants, and a total of 26 patients were randomly assigned to the Study Group (PNFG, n:13) and the Control Group (CG, n:13) . The researcher responsible for randomisation did not participate in data collection or data analysis.

All patients' demographic information (age, gender, body mass index) and disease characteristics (disease duration and EDSS) were recorded. Subsequently, participants' walking, balance, and fatigue status were assessed. Assessments and treatment were conducted at the same time and in the same environment but on different days. Assessments were conducted with rest periods to eliminate fatigue and other potential issues. Two researchers, blinded to randomisation, assessed all patients twice: at baseline (BL) and six weeks later (WL). The physiotherapists administering the treatments did not participate in the assessments. Assignment was concealed from patients until after the baseline assessment. Patients were asked not to discuss their interventions with the assessors during the final assessment. Walking was assessed using a 25-step walking test, balance was assessed statically using a tandem stance test and dynamically using a four-step square test, and fatigue was assessed using a fatigue severity scale.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Gaziantep
    • Gaziantep, Gaziantep, Turkey (Türkiye), 27090
      • Sanko Unıversıty
    • Gaziantep, Gaziantep, Turkey (Türkiye), 27500
      • Sanko Unıversıty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (i) Having been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) according to the 2017 McDonald criteria (Thompson, Banwell et al. 2018), (ii) Aged 18-65 years, (iii) Expanded Disability Status Scale (EDSS) score of 4 or below, (iv) No relapses in the past 6 months.

Exclusion Criteria:

• (i) Having a history of trauma to the lower extremities within the last year, (ii) having a known history of other chronic neurological disorders, (iii) having any contraindications to exercise, (iv) cognitive impairment as defined by a mini-mental test (scoring below 24 points).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: working group; Proprioceptive neuromuscular facilitation (PNF) exercises	Other: exercises; Each of the two groups was given exercise three days a week for six weeks.
Experimental: control group; strengthening exercises	Other: exercises; Each of the two groups was given exercise three days a week for six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
static balance	tandem stance test	6 weeks
dynamic balance	four-square test	6 weeks
gait	25-step walking test	6 weeks
fatigue	Fatigue Severity Scale (fSS): The **Fatigue Severity Scale (FSS)** is a 9-item measure that assesses the severity of fatigue, with each item scored on a scale of 1-7. The average score on the scale is typically considered. **A low FSS score (1.0-3.9)** indicates mild fatigue that does not significantly affect daily life; the individual generally has normal energy levels, and fatigue does not restrict work or social life. A **high FSS score (4.0-7.0)** indicates that fatigue is markedly excessive and negatively affects daily activities; it is consistent with decreased energy, difficulty performing activities, and fatigue seen in chronic illnesses. Clinically, an average score of **4 or above** is considered **significant fatigue**, while a score below 4 is considered **low fatigue**.	6 weeks

Collaborators and Investigators

• Sponsor: Sanko University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): September 16, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: fatigue; gait; balance; multipl skleroz
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue Syndrome, Chronic; Fatigue; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: hakanpolat7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No