NCT07780461

Brief Summary

Parkinson's disease (PD) is a progressive neurodegenerative disorder associated with motor and non-motor impairments that affect physical function, mobility, balance, and quality of life. Although Galicia is one of the Spanish regions with a high prevalence of PD, comprehensive information regarding the functional characteristics of this population remains limited. This observational cross-sectional study aims to characterize the sociodemographic, clinical, cognitive, behavioral, and functional profile of individuals with Parkinson's disease in Galicia and to evaluate the validity and reliability of the Short Physical Performance Battery (SPPB) in this population. The findings will provide updated information on the functional status of people with PD in Galicia and support the use of the SPPB as a practical tool for the assessment of physical performance in clinical and research settings.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress44%
Aug 2026Dec 2026

Study Start

First participant enrolled

August 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 3, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

Parkinson´s DiseasePhysical FunctionShort Physical Performance Battery (SPPB)Functional AssessmentPsychometric Validation

Outcome Measures

Primary Outcomes (4)

  • Test-Retest Reliability of the SPPB

    Reliability of the SPPB assessed through repeated administration after a minimum interval of one week using the Intraclass Correlation Coefficient (ICC).

    Baseline and 1 week

  • Short Physical Performance Battery (SPPB) Total Score

    Evaluation of lower-extremity physical performance through balance, gait speed, and chair-rise tasks. Total score ranges from 0 to 12, with higher scores indicating better physical performance.

    Baseline

  • Internal Consistency of the SPPB

    Internal consistency of the three SPPB components assessed using Cronbach's alpha coefficient.

    Baseline

  • Convergent Construct Validity of the SPPB

    Correlation of SPPB scores with established functional assessment measures (TUG, BBS, and MDS-UPDRS Part III).

    Baseline

Secondary Outcomes (8)

  • Ad Hoc Sociodemographic and Clinical Data Collection Form

    Baseline

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Goetz et al., 2008)

    Baseline

  • International Physical Activity Questionnaire (IPAQ)

    Baseline

  • Mini-Mental State Examination (MMSE) (Folstein et al., 1975; Spanish validation: Lobo et al., 1999)

    Baseline

  • Handgrip Strength Assessment

    Baseline

  • +3 more secondary outcomes

Eligibility Criteria

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

Individuals with a diagnosis of Parkinson's disease

You may qualify if:

  • Clinical diagnosis of Parkinson's disease confirmed by a neurologist.
  • Provision of written informed consent by the participant or, when applicable, by a legally authorized representative.

You may not qualify if:

  • Inability to complete the study assessment procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asociación de Parkinson de la Provincia de Pontevedra

Pontevedra, Pontevedra, 36005, Spain

RECRUITING

Facultad de Fisioterapia

Pontevedra, Pontevedra, 36005, Spain

RECRUITING

Related Publications (11)

  • Motl RW, Learmonth YC, Wojcicki TR, Fanning J, Hubbard EA, Kinnett-Hopkins D, Roberts SA, McAuley E. Preliminary validation of the short physical performance battery in older adults with multiple sclerosis: secondary data analysis. BMC Geriatr. 2015 Dec 3;15:157. doi: 10.1186/s12877-015-0156-3.

    PMID: 26630923BACKGROUND
  • Lopez-Liria R, Vega-Tirado S, Valverde-Martinez MA, Calvache-Mateo A, Martinez-Martinez AM, Rocamora-Perez P. Efficacy of Specific Trunk Exercises in the Balance Dysfunction of Patients with Parkinson's Disease: A Systematic Review and Meta-Analysis. Sensors (Basel). 2023 Feb 6;23(4):1817. doi: 10.3390/s23041817.

    PMID: 36850413BACKGROUND
  • Leddy AL, Crowner BE, Earhart GM. Functional gait assessment and balance evaluation system test: reliability, validity, sensitivity, and specificity for identifying individuals with Parkinson disease who fall. Phys Ther. 2011 Jan;91(1):102-13. doi: 10.2522/ptj.20100113. Epub 2010 Nov 11.

    PMID: 21071506BACKGROUND
  • Kim Y, Park I, Kang M. Convergent validity of the international physical activity questionnaire (IPAQ): meta-analysis. Public Health Nutr. 2013 Mar;16(3):440-52. doi: 10.1017/S1368980012002996. Epub 2012 Jul 2.

    PMID: 22874087BACKGROUND
  • Kegelmeyer DA, Kloos AD, Thomas KM, Kostyk SK. Reliability and validity of the Tinetti Mobility Test for individuals with Parkinson disease. Phys Ther. 2007 Oct;87(10):1369-78. doi: 10.2522/ptj.20070007. Epub 2007 Aug 7.

    PMID: 17684089BACKGROUND
  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

    PMID: 8126356BACKGROUND
  • Brusse KJ, Zimdars S, Zalewski KR, Steffen TM. Testing functional performance in people with Parkinson disease. Phys Ther. 2005 Feb;85(2):134-41.

    PMID: 15679464BACKGROUND
  • Bennie, S., Bruner, K., Dizon, A., Fritz, H., Goodman, B., & Peterson, S. (2003). Measurements of Balance: Comparison of the Timed "Up and Go" Test and Functional Reach Test with the Berg Balance Scale. Journal Of Physical Therapy Science, 15(2), 93-97. https://doi.org/10.1589/jpts.15.93

    BACKGROUND
  • Temporiti F, Mandaresu S, Calcagno A, Coelli S, Bianchi AM, Gatti R, Galli M. Kinematic evaluation and reliability assessment of the Nine Hole Peg Test for manual dexterity. J Hand Ther. 2023 Jul-Sep;36(3):560-567. doi: 10.1016/j.jht.2022.01.007. Epub 2022 Feb 26.

    PMID: 35232627BACKGROUND
  • Morris ME, Martin CL, Schenkman ML. Striding out with Parkinson disease: evidence-based physical therapy for gait disorders. Phys Ther. 2010 Feb;90(2):280-8. doi: 10.2522/ptj.20090091. Epub 2009 Dec 18.

    PMID: 20022998BACKGROUND
  • Martinez-Martin P, Rodriguez-Blazquez C, Alvarez-Sanchez M, Arakaki T, Bergareche-Yarza A, Chade A, Garretto N, Gershanik O, Kurtis MM, Martinez-Castrillo JC, Mendoza-Rodriguez A, Moore HP, Rodriguez-Violante M, Singer C, Tilley BC, Huang J, Stebbins GT, Goetz CG. Expanded and independent validation of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). J Neurol. 2013 Jan;260(1):228-36. doi: 10.1007/s00415-012-6624-1. Epub 2012 Aug 5.

    PMID: 22865238BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Irimia Mollinedo-Cardalda, PT, PhD

    Universidade de Vigo

    PRINCIPAL INVESTIGATOR
  • Iris Machado de Oliveira, PT, PhD

    Universidade de Vigo

    STUDY CHAIR
  • Diego Férnandez-Vázquez, PT, PhD

    Univeridad Rey Juan Carlos

    STUDY CHAIR
  • Esther Monge-Pereira, PT, PhD

    Universidade de Vigo

    STUDY CHAIR

Central Study Contacts

Irimia Mollinedo-Cardalda, PT, PhD

CONTACT

Esther Monge-Pereira, PT, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Permanent Lecturer in Physiotherapy

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 21, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made available to researchers outside the study team. This decision is based on data protection, participant privacy, and confidentiality considerations, as well as the restrictions established in the informed consent process.

Locations