Effect of Treadmill Training on Treadmill and Video Game on the Balance and Walking of People with Parkinson's Disease

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-8tbhyr
• Date of registration: 10/10/2016
• Prospective Registration: No
• Primary sponsor: Universidade Nove de Julho
• Public title: Effect of Treadmill Training on Treadmill and Video Game on the Balance and Walking of People with Parkinson's Disease
• Scientific title: Effect of gait training and virtual reality on balance and gait in individuals with Parkinson’s disease: Protocol for a randomized, controlled, blind, clinical trial
• Date of first enrolment: 01/08/2016
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-8tbhyr
• Study type: Intervention
• Study design: clinical trial treatment, randomized, controlled, parallel, blind, with three arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Claudia Santos Oliveira
• Affiliation: Universidade Nove de Julho

• Name: Claudia Santos Oliveira
• Affiliation: uninove

Key inclusion & exclusion criteria

Inclusion criteria: Diagnosis of idiopathic PD in phase 1, 2 or 3 on the Hoehn and Yahr scale; Score ? 46 on Berg Balance Scale – BBS; Adequate vision (with or without glasses); Adequate hearing (with or without a hearing aid).

Exclusion criteria: Physical disability; Severe heart disease; History of seizure; Uncontrolled hypertension.


Age minimum:
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

F04.754.137.506.662

G11.427.690

Parkinson’s Disease, Gait Training on a Treadmill, Virtual Reality, Balance, Gait

E01.370.600.250

Intervention(s)

F04.754.137.506.662

E01.370.600.250

All procedures will be performed at the Parkinson Association Brazil in Sao Paulo. The individuals will participate in 20-minute training sessions three times a week for four weeks (total: 12 sessions) [20,21]. A specific aspect of the study will be the application of progressive, intensive gait training protocols that will be similar to each other. Heart rate (HR), blood pressure (BP) and perceived exertion will be measured before, during (after 10 minutes of training) and after immediately after training. This procedure will be performed to ensure training intensity within the stipulated target range: HR between 60 and 70% of maximum HR (220 beats per minute – age) [22,23]. BP will need to be below 200/100 mm Hg and the modified Borg scale will be used for the determination of perceived exertion during the exercise session. Each group will received the respective interventions, the main focus of which was physical fitness and motor coordination.

Over ground gait training
Training will be performed in a closed environment and consisted of routine exercises with controlled intensity. For such, hula hoops, cones, steps, balls, colored obstacles, horizontal ladders and stairs will be used. To execute the tasks, the participants walked past and/or around obstacles, went up and down a step, performed gait controlled by horizontal markings on the floor and pace controlled by the therapist’s instructions.


Treadmill training - TT
Prior to the training sessions, the participants will be familiarized with the safe practice of the procedure. The treadmill was equipped with hand rails and a disconnection system to avoid falls. The training sessions were adapted individually to each participant, who will be instruct to walk or run maintaining the HR within

Other

Primary Outcome(s)

Improved dynamic balance measured by scale of BERG after conducting 12 treadmill workout sessions, virtual reality training and conventional training therapy in people with Parkinson's disease

•Berg Balance Scale – BBS – This scale was validated for use in Brazil by Miyamoto et al.[12] and is employed for the evaluation of functional balance. For such, the participant is scored regarding a set of 14 tasks on a five-point scale. The score for each task ranges from 0 (unable to perform the task) to 4 (performs the task independently). The final score ranges from 0 to 56 points, with lower scores denoting a greater risk of falls and higher scores denoting better performance. The cutoff point for the risk of falls is less than 45 points.

Secondary Outcome(s)

outcomes are not expected secondary

Source(s) of Monetary Support

Universidade Nove de Julho

Associação Brasil Parkinson

Secondary Sponsor(s)

Associação Brasil Parkinson

Universidade Nove de Julho