NCT06790992

Brief Summary

Background: Supine-to-Stand Test (SST) requires muscle strength, flexibility, and dynamic balance and can be used as a marker of functional motor competence in patients with Multiple Sclerosis (pwMS). Objectives: To investigate the reliability and validity of SST in pwMS. Methods: Muscle strength was measured using digital goniometer for plantar and dorsiflexor in pwMS (n=44). Manual dexterity was assessed through the 9-hole Peg Test (9HPT). Balance was evaluated using with Berg Balance Test (BBT). Walking speed was assessed using Six-minute Walk test (6MWT). Timed up and go test (TUG), Activity-spesific Balance Confidence scale was used for fear of falling. Quality of life was assessed with MSQOL-54. Results: The test's intraclass correlation was 0.984 (95% CI 0.801-0.995). Significant moderate correlations were found between SST and BBT (r=-0.547, p=0.001), TUG (r=0.619, p\<0.001), and 6MWT (r=-0.642, p\<0.001). A moderate correlation was also found between dominant side plantar flexor strength and SST (r=0.349, p=0.043), but not non-dominant side and bilaterally dorsi flexors (p\>0.05). Additionally, no significant correlation was found between SST and bilaterally 9HPT, MSQOL-54 (p\>0.05). Conclusion: This study establishes SST as a reliable and valid tool for assessing functional motor competence in pwMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

August 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

November 7, 2024

Last Update Submit

January 18, 2025

Conditions

Keywords

multiple sclerosis

Outcome Measures

Primary Outcomes (8)

  • Supine-to-stand Test (SST)

    The test was used to evaluate supine-to-stand ability. The patients were first laid in a supine position without shoes on a soft mat in a quiet laboratory environment. The patient was asked to stand up with the command "start". The duration time was recorded. The average of the tests repeated twice was recorded

    1 years

  • Muscle Strength

    Ankle dorsi and plantar flexors strength were evaluated with digital hand dynamometer (Commander Muscle Tester, JTech, Midvale, USA). Ankle muscle strength could predictor for walking capacity in neurological disorders . pwMS performed 3-s maximum isometric voluntary contraction of ankle dorsiflexor and plantar flexors with the dynamometer placed anterior and posterior to the head of metatarsal bones, respectively . Ankle dorsiflexors and plantar flexor strength were tested separately, bilaterally and twice in the supine and prone position, respectively. The average of the values was taken and recorded as Newton.

    1 years

  • Nine Hole Test

    The 9HPT was used to assess the fine manual dexterity of patients. The patient was instructed to insert pegs into the nine empty pegs on the nine-hole board before removing the pegs while sitting position. The test, which it was designed to be completed as rapidly as possible, was administered bilaterally in two trials for each hand. An average time was reported. The patient's manual dexterity degrades with time. The 9HPT is reliable within and between test sessions, discriminates between healthy participants and pwMS with varying levels of upper limb impairment, and has a good convergent validity with other manual dexterity and more comprehensive upper limb tests

    1 years

  • Berg Balance Test

    It was functional measure of balance commonly used in pwMS. The scale consists of 14 functional activities frequently used in daily life (standing up from sitting, standing without support, sitting without support, sitting from standing, transferring, standing with eyes closed, standing with legs together, reaching forward while standing, picking up an object from the floor, looking back, turning 360 degrees, standing on the healthy side of a chair, standing with one foot in front, and standing on one leg). Activities are scored between 0 and 4. If the individual cannot perform the activity, 0 points are given, and if the individual performs it independently, 4 points are given. Low scores indicate impaired balance. The highest score is 56, with 0-20 points indicating impaired balance, 21-40 points indicating acceptable balance, and 41-56 points indicating good balance

    1 years

  • Timed Up and Go (TUG)

    Test was used for a measure of functional mobility in pwMS . The test measures speed during many functions such as standing up, walking, turning and sitting. In the test, the individual was asked to get up from the chair he was sitting in, walk 3 meters at a safe and normal speed, turn, walk back and sit on the chair and the time was recorded in seconds. As the score increases, pwMS' fear of falling increases.

    1 years

  • Six-Minute Walk Test (6MWT)

    The Six-Minute Walk Test was used to assess walking endurance, following the technique reported by Goldman et al . Each participant was asked to walk as securely and quickly as possible for six minutes without running in a 10-meter corridor. The distance they walked for six minutes was recorded. The test was performed twice, and the average was recorded in centimeters. As the score increases, individuals' walking capacity increases.

    1 years

  • Activity-specific Balance Confidence Scale (ABC)

    ABC scale is used to fear of falling. The ABC scale is a self-reported measure of balance confidence that includes 16 items from daily life (indoors and ourdoors activity). The things were graded from 0 (no confidence) to 100 (full confidence). As the score increases, confidence in the activity increases

    1 years

  • Multiple Sclerosis Quality of Life-54

    The test was used to assess the quality of life. It consists of 2 main groups, 12 subgroups and 2 independent items, namely composite physical health (BFS) and composite mental health (BMS). A high score obtained from the scale indicates a high level of quality of life

    1 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PATIENTS DIAGNOSED WITH MULTIPLE SCLEROSIS ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITAL

You may qualify if:

  • being diagnosed with revised 2017 McDonald criteria,
  • aged older than 18 years,
  • ability to walk with or without aid,
  • no medication changes in the last 2 months,
  • volunteering to participate in the research,
  • not having any obstacles to verbal and cognitive communication.

You may not qualify if:

  • having orthopedic, psychological, and other neurological disorders, having had -a relapse in the past 3 months
  • having pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SANKO University

Gaziantep, şehitkamil, 27500, Turkey (Türkiye)

Location

Related Publications (2)

  • VanSant AF. Age differences in movement patterns used by children to rise from a supine position to erect stance. Phys Ther. 1988 Sep;68(9):1330-9. doi: 10.1093/ptj/68.9.1330.

    PMID: 3420166BACKGROUND
  • Ng SSM, Chen P, Chan TCW, Chang CHL, Cheng RHY, Chow KKL, Yeung AFM, Liu TW, Ho LYW, Yeung JWF, Xu RH, Tse MMY. Reliability and validity of the supine-to-stand test in people with stroke. J Rehabil Med. 2023 Sep 18;55:jrm12372. doi: 10.2340/jrm.v55.12372.

    PMID: 37721097BACKGROUND

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

  • hakan polat, phd

    Sanko University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy and Rehabilitation Department, Assistant Professor

Study Record Dates

First Submitted

November 7, 2024

First Posted

January 24, 2025

Study Start

August 1, 2024

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations