Continuous Behavior Assessment of the Effects of a Physical Therapy Program for Patients With Parkinson's Disease

NCT02745171 | Unknown DMC

• 1 other identifier: 50967815.7.0000.5208
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of degenerative and progressive, with changes in the nigrostriatal pathway, and decreased concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders of the disease. The role of physiotherapy aims to stimulate the security and independence of patients with PD in carrying out activities and to preserve and improve physical function. Some studies have shown the negative effect of the disease on quality of life and functional mobility. Few studies have been conducted to evaluate the effects of long-term therapy in PD, but many report the beneficial effects of a rehabilitation program in a short period of time. Objective: To continually assess the effects after the completion of a physical therapy program in patients with Parkinson's disease. Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental. Patients who are recruited will undergo an assessment using the scales of assessment of functional mobility, quality of life and motor examination before starting physical therapy at the end of treatment and two months after completion of treatment, and the intervals assessments of a month.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Quality of life; Functional mobility; Follow up

Outcome Measures

Primary Outcomes (1)

• change from quality of life

  The PDQ-39 is a specific rating scale of QOL in PD and comprises 39 items that can be answered with five different response options: "never"; "On occasion"; "sometimes"; "often"; "Always" or "it is impossible for me."

  change in quality of life, it is evaluated every month to complete the four-month period.

Study Arms (2)

Control group

NO INTERVENTION

This group will be evaluated after three months there will be a reassessment, in this case the participating subjects do not perform any kind of therapy.

Experimental group

EXPERIMENTAL

There will be an initial evaluation, after a month of physical therapy at the end of the protocol, and twice more after the protocol, both interval a month.

Other: physical therapy

Interventions

physical therapy OTHER

Will be held 15 sessions, 2 times a week, lasting 50 minutes, a physical therapy protocol developed by the Pro-Parkinson Physiotherapy based on the Guide of the Dutch Society of Physiotherapy (Keus, 2004).

Experimental group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Idiopathic Parkinson's disease according to the Bank of London Brain (Hughes et al, 1992);
• Both sexes;
• Patients in stages 1 through 3 for this modified version of the Hoehn \& Yahr scale (HY);
• the patient Agreement to participate in the research after explanation and understanding of it and signing the Consent and Informed.

You may not qualify if:

• cognitive disorder identified by the Mini-Mental State Examination as schooling ;
• Patients with other neurological diseases;
• initiate other rehabilitative treatment throughout and after the physical therapy program.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Maria G Coriolano

CONTACT

(81)984768060; gracawander@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Anatomy at UFPE

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 20, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

BR (1)