An observational study in PARKINSON DISEASE (Disorder), sponsored by University of Vigo. Recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University of Vigo · Observational
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.
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.
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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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 350 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Vigo is the lead sponsor of 53 studies on the registry; 13 are open to participants now.
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Individuals with a diagnosis of Parkinson's disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: 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.
Time frame: Baseline
Internal Consistency of the SPPB
Internal consistency of the three SPPB components assessed using Cronbach's alpha coefficient.
Time frame: Baseline
Convergent Construct Validity of the SPPB
Correlation of SPPB scores with established functional assessment measures (TUG, BBS, and MDS-UPDRS Part III).
Time frame: Baseline
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).
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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
Time frame: Baseline
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).
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
Plan to share: 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.
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