NCT06102148

Brief Summary

The aim of this study is to examine the effects of PNF techniques on pain, motor function, fatigue and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 16, 2023

Last Update Submit

October 20, 2023

Conditions

Keywords

Multiple SclerosisProprioceptive Neuromuscular FacilitationPainMotor FunctionFatigueQuality of Life

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale (VAS)

    Pain

    through study completion, an average of 1 year

  • Multiple Sclerosis Quality of Life-54 (MSQoL-54)

    Quality of Life

    through study completion, an average of 1 year

  • Fatigue Severity Scale and Fatigue Impact Scale (FIS)

    Fatigue

    through study completion, an average of 1 year

  • Timed Up and Go (TUG)

    Mobility and Balance

    through study completion, an average of 1 year

  • The Six-Minute Walk Test (6-MWT)

    Functionality

    through study completion, an average of 1 year

  • Hand Dexterity

    Hand Dexterity

    through study completion, an average of 1 year

Study Arms (2)

PNF Group

EXPERIMENTAL
Other: PNF Group

Control Group

SHAM COMPARATOR
Other: Control Group

Interventions

Exercise training and PNF training

PNF Group

Exercise training

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a clinical diagnosis of Relapsing-Remitting MS (RRMS) as defined by McDonald criteria
  • years of age
  • an Expanded Disability Status Scale (EDSS) score \< 4
  • relapse-free for the last 3 months
  • cognitive impairment that was defined with mini mental test.

You may not qualify if:

  • a history of different neurological diseases
  • having any contraindication for exercise
  • having orthopedic, vision, hearing, or perception problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisPainFatigue

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 26, 2023

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations