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

NCT ID: NCT02745171

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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.

Detailed Description

The Parkinson's disease results from dysfunction of the dopaminergic systems, cholinergic, serotonergic and noradrenergic, though the neuropathological basic pattern is the change of the nigrostriatal pathway, with decreased concentration of dopamine at the level of dopamine receptors in the body striatum.

With still little known etiology in most instances, the Parkinson's disease has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. Additionally, patients may exhibit cognitive deficits and emotional changes with the progression of the disease.

The clinical diagnosis is primarily based on the identification of the cardinal motor symptoms plus the initial response to levodopa therapy . The literature is unanimous in admitting that the use of Levodopa (L-dopa) is the most effective drug for the treatment, and its administration the most recommended in satisfactory symptom control.

In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders associated disease. Although the speed of the motor of the patient learningParkinson's disease is lower than their control group of the same age, rehabilitation, these individuals may also acquire motor skills as well as improve their performance through practice repetition.

Although a physical rehabilitation program to be beneficial to improve the activities of daily living (ADL) and mobility in patients with Parkinson's disease , it is not yet clear how long its effect is sustained. Most clinical trials of physiotherapy in PD were based on short-term rehabilitation programs.

Few studies have been conducted to evaluate the effects of long-term physical therapy in Parkinson's disease, but many report the beneficial effects of a short-term rehabilitation program, without having to concern monitoring after the physical therapy.

Thus this study aims to continuously evaluate the behavior of the effects of a physical therapy program in patients with Parkinson's disease.

Knowledge of the time interval which is the decline of the gains from physiotherapy is a guiding point to guide the patient regarding their return to service for revaluation, also considering the fact that the disease have progressive.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

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.

Group Type: EXPERIMENTAL

physical therapy

Intervention Type: 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).

Interventions

physical therapy

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with Idiopathic Parkinson's disease according to the Bank of London Brain (Hughes et al, 1992);

2. Both sexes;

3. Patients in stages 1 through 3 for this modified version of the Hoehn & Yahr scale (HY);

4. the patient Agreement to participate in the research after explanation and understanding of it and signing the Consent and Informed.

Exclusion Criteria

1. cognitive disorder identified by the Mini-Mental State Examination as schooling ;

2. Patients with other neurological diseases;

3. initiate other rehabilitative treatment throughout and after the physical therapy program.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

MARIA DAS GRAÇAS WANDERLEY DE SALES CORIOLANO

Associate Professor Department of Anatomy at UFPE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Maria G Coriolano

Role: CONTACT

gracawander@hotmail.com

(81)984768060

Facility Contacts

Bruna P Prudente

Role: primary

brubrupp@hotmail.com

(81)99728-0870

References

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.

Reference Type: DERIVED

PMID: 38588457 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36602886 (View on PubMed)

Other Identifiers

50967815.7.0000.5208

Identifier Type: -

Identifier Source: org_study_id