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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Vigo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Inability to complete the study assessment procedures.

Trial population

Individuals with a diagnosis of Parkinson's disease

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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).

Time frame
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.

Time frame
Baseline
3

Internal Consistency of the SPPB

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

Time frame
Baseline
4

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

Secondary outcomes

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).

Time frame
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.

Time frame
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.

Time frame
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

Time frame
Baseline

Other outcomes

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