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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physical therapy
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Quality of life, Functional mobility, Follow up

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de PernambucoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Full Information

First Posted
March 30, 2016
Last Updated
April 19, 2016
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02745171
Brief Title
Continuous Behavior Assessment of the Effects of a Physical Therapy Program for Patients With Parkinson's Disease
Official Title
Continuous Behavior Assessment of the Effects of a Physical Therapy Program for Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Quality of life, Functional mobility, Follow up

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
change from quality of life
Description
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."
Time Frame
change in quality of life, it is evaluated every month to complete the four-month period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria G Coriolano
Phone
(81)984768060
Email
gracawander@hotmail.com
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruna P Prudente
Phone
(81)99728-0870
Email
brubrupp@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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