Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000097943
Ethics application status
Approved
Date submitted
18/01/2011
Date registered
28/01/2011
Date last updated
28/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
kinesiotherapy associated with electrical stimulation in patients with Parkinson's
Scientific title
kinesiotherapy associated with electrical stimulation in patients with Parkinson's
Secondary ID [1] 253432 0
there's no other number
Universal Trial Number (UTN)
U1111-1119-0971
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 260979 0
Condition category
Condition code
Neurological 259148 259148 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 259149 259149 0 0
Physiotherapy
Neurological 259150 259150 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electrial stimulation:
The device has two channels, with each channel has two electrodes, resulting in four electrodes. a channel with two parallel electrodes were placed in the thoracic spine and another channel with two parallel electrodes were placed in the lumbar spine. Electrial stimulation was applied to the motor point of the paravertebral muscles. The parameters used 220 ms for duration, frequency of 40 Hz, cycle on (connected) 06 seconds and cycle off (off) 12 seconds; rise and fall 05 05
Kinesiotherapy:
1 - The patient standing on the ball with both feet on the ground. The hips, knees and feet are flexed at 90 degrees. Knees and feet are hip-width apart, and the patient was instructed to get up and sit on the ball with the contraction produced by FES 2 sets of 10 times with 2 minutes rest between exercise and other
2 - The patient standing on the ball with both feet on the ground. The hips, knees and feet are flexed at 90 degrees. Knees and feet are hip-width apart, and the patient was bending over the shoulder trunk extension along with the contraction produced by FES in two sets of 10 times.
3 - Exercise for spinal extension against gravity with forward flexion of the arms, to stand facing the wall holding a Swiss ball, the length of the column is practiced against gravity for 2 sets of 10 times.
4 - Exercise for the mobility of hip flexion and shoulder flexion involving the stretching of paraspinal: without assistance from the FES, sitting on a chair, pushes the ball forward and backward in a series of 10 times, with 30 seconds.
Cooling exercise: patient sitting on the ball, doing breathing pattern quiet for 2 minutes.
The subject performed 2 consecutive weeks of treatment (excluding weekends) Totaling 10 sessions of 50 minutes each. The sessions were conducted individually by trained physical therapist
Intervention code [1] 257877 0
Rehabilitation
Comparator / control treatment
compared before and after treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 261964 0
To examine postural held digital photograph of the individual
(Sony - Cyber-shot - 7.2 mega pixels), positioned on a tripod (Vanguard VT-131) at a height of 90 cm above ground, distance of 3 meters from the sample . The pictures were taken with the sample without a shirt, dress shorts, standing orthos tactical plans: the anterior, posterior and lateral left and right. Specific anatomical points were marked with polystyrene spheres of 1 cm in diameter and attached with double sided tape. As standard protocol SAPO (http://sapo.incubadora.fapesp.br).
Timepoint [1] 261964 0
The photographs were analyzed by SAPO is a free software user friendly tutorials for postural assessment with scientific and creating a database and is available at http://sapo.incubadora.fapesp.br.
Printing plantigrade was recorded to preserve the position and dimensions based on different planes photographed. The vertical reference was obtained from a plumb line marked with 2 points and 1 meter attached to the ceiling. The horizontal alignment of the floor, the tripod and the machine was measured with a level of timber.
Two other variables were analyzed asymmetry in the sagittal and frontal planes, corresponding to the projection of center of gravity (CG) on the basis of support.
Was assessed at pre-treatment and two weeks after treatment
Secondary outcome [1] 268888 0
Scale Range estimate unified Parkinson (UPDRS)
The scale Range estimate unified Parkinson (UPDRS) assesses the signs, symptoms and activities of certain patients by self report and clinical observation. It comprises 42 items, totaling 147 points, divided into four parts: mental activity, behavior and mood 16 points, activities of daily living (ADLs) 52 points, 56 points and holding motor complications of drug therapy 23 points. The score for each item ranges from 0 to 4, with the maximum value indicates greater disease involvement and the minimum normal.
Timepoint [1] 268888 0
Was assessed at pre-treatment and two weeks after treatment

Eligibility
Key inclusion criteria
The sample consists of a male patient, 45 years with a clinical diagnosis of Parkinson's disease
be in possession of Parkinson's disease being the staging of Hoehn and Yahr stage Modified 2 or above
Minimum age
45 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patient who has Parkinson's disease being the staging of Hoehn and Yahr Modified below 2

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1
Accrual to date
Final
Recruitment outside Australia
Country [1] 3143 0
Brazil
State/province [1] 3143 0
Pouso Alegre

Funding & Sponsors
Funding source category [1] 258341 0
University
Name [1] 258341 0
University Vale to sapucai
Country [1] 258341 0
Brazil
Primary sponsor type
Individual
Name
Andreia Maria Silva
Address
Rua Benjamin Constant 93
City: Alfenas
State: MG
CEP:37130-000
Country
Brazil
Secondary sponsor category [1] 257495 0
None
Name [1] 257495 0
Address [1] 257495 0
Country [1] 257495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260317 0
1234/2010
Ethics committee address [1] 260317 0
Ethics committee country [1] 260317 0
Brazil
Date submitted for ethics approval [1] 260317 0
02/12/2009
Approval date [1] 260317 0
02/01/2010
Ethics approval number [1] 260317 0
1234/2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32104 0
Address 32104 0
Country 32104 0
Phone 32104 0
Fax 32104 0
Email 32104 0
Contact person for public queries
Name 15351 0
Andreia Maria Silva
Address 15351 0
Address: Rua Benjamin Constant 93,
City: Alfenas
State: MG
CEP: 37130-000
Country 15351 0
Brazil
Phone 15351 0
553532911486
Fax 15351 0
Email 15351 0
[email protected]
Contact person for scientific queries
Name 6279 0
Andreia Maria Silva
Address 6279 0
Rua Benjamin Constant 93
City: Alfenas
state: MG
CEP: 37130-000
Country 6279 0
Brazil
Phone 6279 0
553532911486
Fax 6279 0
Email 6279 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.