Treadmill walking in subjects with Parkinson's disease

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5qffrt
• Date of registration: 02/02/2012
• Primary sponsor: Universidade Federal do Rio Grande do Norte - Brazil
• Public title: Treadmill walking in subjects with Parkinson's disease
• Scientific title: Effects of treadmill walking training with additional body load in subjects with Parkinson's disease
• Date of first enrolment: 05/01/2011
• Target sample size: 30
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5qffrt/
• Study design: Therapeutic, parallel, three arms, single-blind, randomized controlled clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Larissa Trigueiro
• Affiliation: Universidade Federal do Rio Grande do Norte

• Name: Larissa Trigueiro
• Affiliation: Universidade Federal do Rio Grande do Norte

Key inclusion & exclusion criteria

Inclusion criteria: Idiopathic Parkinson's disease, diagnosed by a neurologist experienced in movement disorders, according to the criteria of brain bank in London;
Both sexes aged over 40 and less than 75 years;
In the moderate stage of disease (stages 2 and 3, according to the disability scale of Hoehn and Yahr modified) Use of antiparkinsonian medication;
Walk without any brace or assistive device to walk independently, a walkway of 8 meters (m);
Absence of other neurological disorders, musculoskeletal, cardiovascular and / or breathing that prevent treadmill gait training;
No visual changes and / or uncorrected hearing, that might interfere with the implementation of the Protocol;
Absence of severe cognitive impairment that prevented understanding of simple verbal instructions, as detected by the mini mental state examination;
Not having been subjected to surgery extereotáxica;
Signing the consent form (ICF).
Exclusion criteria: Blood pressure (SBP) and systolic and diastolic values above, respectively, 200 mmHg and 110 mmHg before and / or after training;
Heart rate (HR) above the permitted submaximal values, calculated by formula [FCsub = 0.75 x (220 - age)];
Change in dose and / or the type of antiparkinsonian medication during the training period;
Presence of pain and / or severe muscle fatigue that prohibits continued the exercise.

Age minimum: 40Y
Age maximum: 75Y
Gender: -

Health Condition(s) or Problem(s) studied

Neurological gait disorders, Parkinson's disease
C10.597.404
C10.228.140.079.862.500

Intervention(s)

The training protocol will occurr over 4 consecutive weeks, with three weekly sessions of 30 minutes each. Participants allocated to one of three groups (experimental I, II experimental and control) will be subject to the following conditions:

-Control group: 10 individuals with Parkinson's disease (PD) will hold treadmill gait training only on the mat.

-Experimental group I: 10 individuals with PD will hold treadmill gait training in the wake associated with the addition of 5% load, equivalent to body weight. The load will be positioned at waist height.

-Experimental group II: 10 PD patients will perform the same type of training, the group mentioned above, with the addition of 10% load.

Primary Outcome(s)

Expected Outcome: Increased speed, stride length, step cadence and percentage of time balance and reduction in the percentage of support time and double support, the group submitted to training with the addition of 10% load.

For these outcomes will be analyzed: spatial and temporal variables - speed (m / s), stride length (m), stride length (m), cadence (steps / min), percentage of the time balance (%), percent support time (%) and percentage of double support time (%).

Expected outcome: Increase in measurements of angular variables.

For this outcome will be analyzed: angular variables - the hip, the maximum extension in support maximum bending in the balance and range of motion (ROM) of the hip, knee, supporting the maximum extent, the maximum flexion in swing, the angle knee ROM at initial contact and knee and ankle, the maximum dorsiflexion in swing, plantar flexion of the fingers when collecting soil at the end of the stance phase (toe-off), the ankle angle at initial contact and ADM ankle.

Secondary Outcome(s)

- Expected outcome: reduction in the values of the activity domain of daily living and motor examination.

For this outcome will be analyzed to assess the scale unified Parkinson's disease (UPDRS) before and after training, which assesses the severity of Parkinson's disease, so clinical and functional. Scores range from 0 to 4, where higher scores are related to a greater degree of severity of PD.

Secondary ID(s)

063/2011

CAAE 0013.0.051.000-11

Source(s) of Monetary Support

CNPq - Brasilia, DF, Brazil

Secondary Sponsor(s)

Universidade Federal do Rio Grande do Norte - Brazil