Translation and Validation of BELA-p-K… | Clinical Trial

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

About this study

In order to provide an appropriate endpoint for the assessment of the effectiveness of rehabilitation treatments on QoL of PD patients, in this study we translated and then validated the Belastungsfragebogen Parkinson kurzversion (BELA-P-k). This tool allows evaluating separately two crucial aspects: i) the loss of personal autonomy in activities of daily life and ii) the psychological and psychosocial impact of the disease.

The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled out the questionnaire. PD patients were also evaluated by using the Parkinson Disease Questionnaire -39 (PDQ39), the Unified Parkinson's Disease Rating Scale (UPDRS), the Mini Mental State Examination (MMSE) and the Frontal Assessment Battery (FAB) The internal consistency of the questionnaire was assessed by means of Cronbach's alpha coefficient.

The discriminant validity was assessed by testing for differences between mean values for patients grouped according to Hoehn and Yahr stages. This analysis was carried out by a one-way analysis of variance.

Finally, the construct validity was determined by assessing the relationship (Spearman rank correlation coefficient) between Bela-P-k and the PDQ39

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parkinson's Disease

Exclusion criteria

any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous twelve months;
other chronic diseases with a known impact in QoL.
MMSE < 24

Treatment and study plan

BELASTUNGSFRAGEBOGEN PARKINSON KURZVERSION (BELA-P-K)

Diagnostic Test

we proposed the translation and validation of Bela-p-K, a questionnaire that evaluates the Quality of Life in parkinsonian patients.

we applied the method of translation and back-translation at dutch version of questionnaire. after, we evaluated 103 PD patients with Bela-p-K and PDQ39.

The internal consistency of questionnaire was analyzed calculating alpha-Chronbach. We also evaluated the construct validity correlating Bela-p-K and PDQ39

Primary outcomes

Bela-p-K

Time frame: 15 minuts

questionnaire for QoL evaluation

Sponsors and collaborators

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Other

Registry information

Official study title

Italian Validation of the Belastungfragebogen Parkinson Kurzversion (BELA-P-K): a Disease-specific Questionnaire for Evaluation of the Subjective Perception of Quality of Life.

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Mar 8, 2017
Registry last updated: Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed