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PARKINSON DISEASE (Disorder)PDSPPBNCT07780461

Characterization and Validation of the Short Physical Performance Battery in Individuals Diagnosed With Parkinson's Disease

An observational study of PARKINSON DISEASE (Disorder), run by University of Vigo at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PARKINSON DISEASE (Disorder)
How many people
350 participants
Where
2 sitesSpain
Study dates
1 Aug 2026to 25 Dec 2026
How long will I take part?
1 Week
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals with a diagnosis of Parkinson's disease

Who may be able to join

  • 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.

Who cannot join

  • Inability to complete the study assessment procedures.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Irimia Mollinedo-Cardalda, PT, PhD contact

+34986801771

imollinedo@uvigo.es

Esther Monge-Pereira, PT, PhD contact

+34986801750

esther.monge@uvigo.es

Spain2 sites, 2 recruiting

  • Asociación de Parkinson de la Provincia de Pontevedra

    Pontevedra, Pontevedra, 36005

    Begoña Cerqueiro, Msc, 647421254, apropark@gmail.com

    Recruiting

  • Facultad de Fisioterapia

    Pontevedra, Pontevedra, 36005

    Mercedes Soto, phd, +34986801750, confisio@uvigo.es

    Recruiting

Other trials in Spain

About this study

Official title: Observational Study for the Functional Characterization of the Population Diagnosed With Parkinson's Disease in Galicia, and Validation of the Short Physical Performance Battery in Individuals Diagnosed With Parkinson's Disease

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.

Read the detailed description

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by a combination of motor and non-motor symptoms that negatively affect physical function, mobility, independence, and quality of life. Although advances in pharmacological and surgical treatments have improved symptom management, PD remains associated with progressive functional decline. Accurate assessment of physical performance is therefore essential for clinical decision-making, rehabilitation planning, and monitoring disease progression.

The Short Physical Performance Battery (SPPB) is a widely used measure of lower-extremity physical performance that evaluates balance, gait speed, and chair-rise ability. The instrument has demonstrated strong psychometric properties in older adults and several chronic conditions; however, evidence regarding its measurement properties in individuals with Parkinson's disease remains limited.

This multicenter observational study aims to characterize the functional profile of individuals with Parkinson's disease living in Galicia, Spain, and to evaluate the psychometric properties of the SPPB in this population. The study will examine the reliability, internal consistency, and construct validity of the instrument, as well as its relationship with established measures of disease severity, balance, mobility, dexterity, cognitive status, physical activity, and muscle strength.

6

7 Participants will undergo a comprehensive multidimensional assessment during the ON phase of their antiparkinsonian medication. In addition to conventional clinical and functional evaluations, selected mobility and physical performance tasks will be instrumented using wearable inertial sensor technology to obtain objective kinematic data. A subgroup of participants will complete a second SPPB assessment after a short interval to evaluate test-retest reliability.

The results of this study are expected to provide evidence regarding the suitability of the SPPB as a clinical and research tool for assessing physical performance in individuals with Parkinson's disease. Furthermore, the study will offer valuable information about the functional characteristics of people living with PD in Galicia, supporting future rehabilitation strategies and outcome assessment in this population.

Keywords
Parkinson´s Disease, Physical Function, Short Physical Performance Battery (SPPB), Functional Assessment, Psychometric Validation
Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and 1 week

  2. 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.

    Measured: Baseline

  3. Internal Consistency of the SPPB

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

    Measured: Baseline

  4. Convergent Construct Validity of the SPPB

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

    Measured: Baseline

Secondary outcomes (8)

  1. Ad Hoc Sociodemographic and Clinical Data Collection Form

    An individual case report form was developed to collect the following participant characteristics and clinical data separately: age (years), sex (male/female), time since Parkinson's disease diagnosis (years, calculated from the date of diagnosis), Hoehn and Yahr stage (stage 1-5), comorbidities (presence and type), Parkinson's disease-specific pharmacological treatment (type and route of administration), disease-specific interventions such as deep brain stimulation (presence/absence and type), and physiotherapy treatment (type and frequency).

    Measured: Baseline

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

    The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a validated scale assessing Parkinson's disease (PD) severity and progression. It evaluates motor and non-motor symptoms. Total scores range from 0 to 272, with higher scores indicating greater disease severity and worse outcomes.

    The scale has four parts: Part I assesses non-motor experiences of daily living; Part II assesses motor experiences of daily living; Part III is a clinician-administered motor examination assessing rigidity, bradykinesia, gait, posture, balance, and tremor in relation to medication status (ON/OFF); and Part IV assesses motor complications, including dyskinesias and motor fluctuations.

    Measured: Baseline

  3. International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire (IPAQ) is a 7-item self-report instrument assessing physical activity during the previous 7 days. Physical activity is expressed as MET-minutes/week, with higher scores indicating greater physical activity. Participants are classified as having low (<600 MET-min/week), moderate (600-2999 MET-min/week), or high (≥3000 MET-min/week) physical activity levels.

    Measured: Baseline

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

    The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool designed to assess global cognitive function and detect cognitive impairment or dementia. It is commonly used in both clinical practice and research to monitor cognitive status over time. The MMSE evaluates five cognitive domains: orientation to time and place, immediate memory registration, attention and calculation, language, and visuospatial construction. Total scores range from 0 to 30, with higher scores indicating better cognitive performance. Cognitive impairment is typically classified as normal (24-30), mild (19-23), moderate (10-18), or severe (0-9). Interpretation of results should consider the participant's educational level, as years of formal education may influence performance

    Measured: Baseline

  5. Handgrip Strength Assessment

    Upper-limb muscle strength will be assessed using a Saehan SH5001 hydraulic hand dynamometer (Saehan Corporation). Participants will perform the test in either a standing or seated position, with the elbow extended and slightly away from the trunk. Three measurements will be obtained for each hand, and the mean value will be calculated and recorded in kilograms (kg).

    Measured: Baseline

  6. Nine-Hole Peg Test (9HPT) (Proud et al., 2019)

    The Nine-Hole Peg Test (9HPT) is a standardized and widely used measure of finger dexterity and upper extremity function. It assesses fine motor coordination by requiring participants to place nine pegs into nine holes on a pegboard and then remove them as quickly as possible, using one hand at a time. During the assessment, participants are seated at a table with the testing apparatus positioned in front of them. The task is performed separately with each hand, typically beginning with the non-dominant hand. The examiner records the time required to complete the task in seconds. Performance is based on completion time, with shorter times indicating greater manual dexterity and better fine motor function.

    Measured: Baseline

  7. Berg Balance Scale (BBS) (Qutubuddin et al., 2005)

    The Berg Balance Scale (BBS) is a validated clinical measure of balance performance, functional mobility, and fall risk in individuals with Parkinson's disease. The scale consists of 14 functional tasks that assess balance during sitting, standing, reaching, turning, transfers, and changes in position. Each item is scored on a 5-point scale ranging from 0 (unable to perform) to 4 (performs independently), with a total score ranging from 0 to 56. Higher scores indicate better balance and greater functional independence. Total scores are commonly interpreted as follows: 0-20, high risk of falls and severe dependency; 21-40, moderate risk of falls and moderate dependency; and 41-56, low risk of falls and greater independence. The BBS is widely used in clinical and research settings to evaluate balance impairments and monitor functional outcomes over time.

    Measured: Baseline

  8. Timed Up and Go Test (TUG) (Nocera et al., 2013)

    The Timed Up and Go (TUG) test is a validated measure of functional mobility and fall risk in individuals with Parkinson's disease. Participants are instructed to stand up from a chair with armrests, walk 3 meters, turn around, walk back to the chair, and sit down. Performance is assessed by recording the time (seconds) required to complete the task. Shorter completion times indicate better functional mobility, while longer times are associated with a greater risk of falls.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start1 Aug 2026
  3. Primary completion25 Nov 2026 (estimated)
  4. Study completion25 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
350 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780461
Sponsor's protocol ID
PDSPPB
Acronym
PDSPPB
Status last verified
Aug 2026
First submitted
3 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 26630923

  • 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.

    PubMed 36850413

  • 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.

    PubMed 21071506

  • 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.

    PubMed 22874087

  • 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.

    PubMed 17684089

  • 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.

    PubMed 8126356

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

    PubMed 15679464

  • 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

  • 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.

    PubMed 35232627

  • 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.

    PubMed 20022998

  • 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.

    PubMed 22865238

Questions about this trial

What is this clinical trial studying?

An observational study of PARKINSON DISEASE (Disorder), run by University of Vigo at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Irimia Mollinedo-Cardalda, PT, PhD (+34986801771, imollinedo@uvigo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test-Retest Reliability of the SPPB (time frame: Baseline and 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07780461, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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