The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease

NCT03774225 | Unknown

• 1 other identifier: Pâmela e Amarílis
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo, Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in two groups: Experimental Group (EG), that performed the balance and gait training based on games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance (MVG) provided by a PT and a control group (CG) that performed an identical training with no MVG during the training.

Conditions

Parkinson Disease

Keywords

Virtual Reality; International Classification of Functioning; Disability and Health; Rehabilitation; Gait; Balance

Outcome Measures

Primary Outcomes (3)

• Change in Functional balance and gait with Best Test

  A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability

  1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)

• Change in Gait with 6 minut walk test

  a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions

  1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)

• Change in Functional balance with Rapid turn test

  Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left).

  1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)

Secondary Outcomes (3)

• Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale

  1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)

• Risk of falls with FES-I scale

  1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)

• Endurance with 6 minut walk test

  1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)

Study Arms (3)

Manual and verbal guidance (MVG)

EXPERIMENTAL

The MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system®

Other: Virtual Reality with Manual and Verbal Guidance; Other: Virtual Reality with No Manual and Verbal Guidance; Other: Physical Therapy

No manual and verbal guidance (NMVG)

EXPERIMENTAL

The NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern.

Other: Virtual Reality with Manual and Verbal Guidance; Other: Virtual Reality with No Manual and Verbal Guidance; Other: Physical Therapy

Physical Therapy

ACTIVE COMPARATOR

The Control Group will be trained by conventional Physical Therapy exercises.

Other: Virtual Reality with Manual and Verbal Guidance; Other: Virtual Reality with No Manual and Verbal Guidance; Other: Physical Therapy

Interventions

Virtual Reality with Manual and Verbal Guidance OTHER

Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.

Also known as: Experimental Group with Manual and Verbal Guidance (MVG)

Manual and verbal guidance (MVG); No manual and verbal guidance (NMVG); Physical Therapy

Virtual Reality with No Manual and Verbal Guidance OTHER

Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game.

Also known as: Experimental Group with No Manual and Verbal Guidance (NMVG)

Manual and verbal guidance (MVG); No manual and verbal guidance (NMVG); Physical Therapy

Physical Therapy OTHER

Patients of the control group will be trained with balance exercises by a experient physiotherapist.

Also known as: Control Group

Manual and verbal guidance (MVG); No manual and verbal guidance (NMVG); Physical Therapy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
• Active treatment with levodopa
• Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification

You may not qualify if:

• Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
• Severe respiratory and / or cardiovascular conditions
• Visual and / or auditory deficit that can not be corrected with orthotics;
• Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance;
• Previous experience with Microsoft XBOX Kinect® games;
• Be in rehab at another location concomitant with study training.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Brazil Parkinson Association

São Paulo, 04142-092, Brazil

Location

Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

São Paulo, 05360-160, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities; Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria Elisa P Piemonte

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The assessments where conducting by a blind examiner (investigator) in different days of the training. The examinator wasn't know which group the participant would be performing
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-blind, parallel-group, randomised trial

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: December 12, 2018
• Study Start: December 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: July 20, 2019
• Last Updated: February 18, 2019

Record last verified: 2018-07

Locations

BR (2)