The Effects Of DBS Of Subthalamıc Nucleus On Functionality In Patıents With Parkinson's Disease: Short-Term Results

Not Applicable

• Conditions: Surgery; Muscle Weakness; Parkinson Disease; Respiration; Decreased
• Interventions: Device: MIP and MEP

• Registration Number: NCT03797976
• Lead Sponsor: Mustafa Kemal University

Brief Summary

Parkinson's disease is a progressive chronic neurodegenerative disease. In cases where drug treatment is insufficient and drug use is not possible due to drug side effects, highly effective and low-risk surgical treatment options could be used. In Parkinson's Disease; findings such as chest wall rigidity and weakness of the respiratory muscle strength occur. The aim of this study was to determine the effect of preop and postop DBS surgery on respiratory muscle strength, respiratory function and physical performance in patients with Parkinson's disease.

Detailed Description

In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle strength, exercise capacity, functionality, and muscle strength will be evaluated

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Lack of any neurological disease other than Parkinson's
• DBS surgery to be performed in the STN region

Exclusion Criteria

• Patients with advanced cognitive impairment
• Patients with pulmonary, neurological and orthopedic diseases affecting functionalities
• Pregnancy
• Patients in whom the stimulation was canceled due to infection after surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parkinson's Disease Group	MIP and MEP	MIP and MEP Respiratory Function Test Strength Test

Primary Outcome Measures

Name	Time	Method
Functional exercise capacity	Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months	6 minute walking test

Secondary Outcome Measures

Name	Time	Method
Muscle strength	Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months	Muscle Testing Device (N)
Grip Test (Peripheral muscle strength)	Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months	Hand Held Dynamometer (kgf)
Pulmonary functions	Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months	Spirometry
Inspiratory and expiratory muscle strength (MIP, MEP)	Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months	Mouth pressure device

Trial Locations

Locations (1)

Hatay Mustafa Kemal University; 🇹🇷 Antakya, Hatay, Turkey