GBPDC: Gut-Brain in PD Consortium Master Protocol
NCT07567794
Basal Ganglia Diseases, Brain Diseases
Stanford, California, United States
View Trial DetailsNCT Number: NCT07780461
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Asociación de Parkinson de la Provincia de Pontevedra, Pontevedra, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 1 week
Reliability of the SPPB assessed through repeated administration after a minimum interval of one week using the Intraclass Correlation Coefficient (ICC).
Time frame: Baseline
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 three SPPB components assessed using Cronbach's alpha coefficient.
Time frame: Baseline
Correlation of SPPB scores with established functional assessment measures (TUG, BBS, and MDS-UPDRS Part III).
Time frame: Baseline
An individual case report form developed to collect the following information for each participant: age, sex, time since Parkinson's disease diagnosis (date of diagnosis), Hoehn and Yahr stage, comorbidities, Parkinson's disease-specific pharmacological treatment (oral or parenteral), disease-specific interventions such as deep brain stimulation, and physiotherapy treatment
Time frame: Baseline
The MDS-UPDRS is a validated clinical rating scale widely used to assess the severity and progression of Parkinson's disease (PD) over time. It provides a comprehensive evaluation of both motor and non-motor symptoms and is considered the standard outcome measure for monitoring disease status in clinical and research settings.
The scale consists of four parts: Part I assesses non-motor experiences of daily living, including cognitive impairment, psychiatric symptoms, sleep disturbances, autonomic symptoms, pain, and fatigue; Part II evaluates motor experiences of daily living through patient-reported difficulties in speech, swallowing, handwriting, mobility, tremor, and activities of daily living; Part III is a clinician-administered motor examination assessing rigidity, bradykinesia, gait, posture, balance, and tremor, performed in relation to antiparkinsonian medication status (ON/OFF); and Part IV evaluates motor complications, including dyskinesias, motor fluctuations, and painful
Time frame: Baseline
The International Physical Activity Questionnaire (IPAQ) is a 7-item self-report instrument that assesses physical activity performed during the previous 7 days. It is commonly used to evaluate physical activity levels in research settings. Based on responses, participants are classified into three categories of physical activity: low, moderate, or high.
Time frame: Baseline
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Esther Monge-Pereira, PT, PhD
CONTACT
Irimia Mollinedo-Cardalda, PT, PhD
CONTACT
University of Vigo
Other
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
Acronym: PDSPPB
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