Biofeedback Balance Exercises in Parkinson's Disease

NCT04997213 | Completed

• 1 other identifier: AIBU-FTR-EY-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effectiveness of static posturography-assisted biofeedback exercises in PD-related balance disorder.

Conditions

Parkinson Disease; Balance; Distorted

Outcome Measures

Primary Outcomes (9)

• The Hoehn and Yahr Scale

  All patients in this study were classified based on the Hoehn and Yahr scale prior to treatment. This scale is widely used for classifying PD into five stages. It permits objective evaluation of the progression of the disease, from Stage 0 (no disease symptoms) to Stage 5 (the patient is confined to a wheelchair or bed).

  Baseline

• The Movement Disorder Society Unified Parkinson's Disease rating Scale

  This is an extensive scale employed for the clinical evaluation of severity of PD. It consists of four sections including non-motor findings, motor problems, motor findings, and treatment complications. Fourteen motor findings (0 - no finding, or normal, 4- severe finding) in the second section of the scale and comprising the motor problems part were evaluated before treatment in this study.

  Baseline

• The Movement Disorder Society Unified Parkinson's Disease rating Scale

  This is an extensive scale employed for the clinical evaluation of severity of PD. It consists of four sections including non-motor findings, motor problems, motor findings, and treatment complications. Fourteen motor findings (0 - no finding, or normal, 4- severe finding) in the second section of the scale and comprising the motor problems part were evaluated before treatment in this study.

  6 weeks

• Tinetti Balance and Gait Assessment

  This scale consists of two sections assessing gait and balance. The first nine questions concern balance, and the following seven concern gait. The total possible score is 28, consisting of 12 for the gait scale and 16 for the balance scale

  Baseline

• Tinetti Balance and Gait Assessment

  This scale consists of two sections assessing gait and balance. The first nine questions concern balance, and the following seven concern gait. The total possible score is 28, consisting of 12 for the gait scale and 16 for the balance scale

  6 weeks

• Berg Balance Scale

  This scale consists of 14 sections and measures the ability to maintain balance during voluntary movements and postural changes in the trunk and extremities. Scoring is between 0 and 4 (0: unable to complete the task, 4: normal performance). The highest possible score is 56. Scores of 0-20 indicate balance disorder, scores of 21-40 indicate acceptable balance, and scores of 41-56 indicate good balance

  Baseline

• Berg Balance Scale

  This scale consists of 14 sections and measures the ability to maintain balance during voluntary movements and postural changes in the trunk and extremities. Scoring is between 0 and 4 (0: unable to complete the task, 4: normal performance). The highest possible score is 56. Scores of 0-20 indicate balance disorder, scores of 21-40 indicate acceptable balance, and scores of 41-56 indicate good balance

  6 weeks

• Timed Up and Go Test

  TUG evaluation was performed before and after treatment. In this test, the subject is asked to stand up from a chair, walk 3 meters, turn around, walk back to the chair and sit back down, and the time taken to perform this task is recorded in seconds.

  Baseline

• Timed Up and Go Test

  TUG evaluation was performed before and after treatment. In this test, the subject is asked to stand up from a chair, walk 3 meters, turn around, walk back to the chair and sit back down, and the time taken to perform this task is recorded in seconds.

  6 weeks

Secondary Outcomes (6)

• Tandem Stance Test

  Baseline

• Tandem Stance Test

  6 weeks

• Health Assessment Questionnaire

  Baseline

• Health Assessment Questionnaire

  6 weeks

• Beck Depression Inventory

  Baseline

Study Arms (2)

Interventional group

EXPERIMENTAL

Biofeedback system is a center of pressure-controlled video game-based exercise system designed for patients with neurological and orthopedic diseases and provides balance training using auditory, visual, and pressure biofeedback. The system contains several games, each designed to focus on a different component of balance. Biofeedback is provided by means of a monitor in front of the patient. The balance exercises program involved a total of 18 sessions, each lasting 20 min, three times a week for six weeks, and were individually tailored based on the patient's tolerance and current motor and sensorial capacities. All patients performed conventional exercises.

Other: Biofeedback exercises; Other: Conventional Exercises

Control group

ACTIVE COMPARATOR

Classic balance exercises were performed (two-leg stance, semi-tandem stance, tandem stance, standing on one leg, tandem walking, turning completely around, heel-to-toe stance, and standing with the eyes closed). Patients with balance disorder first were commenced balance training in a seated position before progressing to standing exercises, to the extent that these could be tolerable.

Other: Conventional Exercises

Interventions

Biofeedback exercises OTHER

Biofeedback system is a center of pressure-controlled video game-based exercise system designed for patients with neurological and orthopedic diseases and provides balance training using auditory, visual, and pressure biofeedback. The system contains several games, each designed to focus on a different component of balance. Biofeedback is provided by means of a monitor in front of the patient. The balance exercises program was involved a total of 18 sessions, each lasting 20 min, three times a week for six weeks, and was individually tailored based on the patient's tolerance and current motor and sensorial capacities. All patients performed conventional exercises.

Interventional group

Conventional Exercises OTHER

Classic balance exercises were performed (two-leg stance, semi-tandem stance, tandem stance, standing on one leg, tandem walking, turning completely around, heel-to-toe stance, and standing with the eyes closed). Patients with balance disorder first could be commenced balance training in a seated position before progressing to standing exercises, to the extent that these could be tolerable.

Control group; Interventional group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease,
• Age 40 - 85

You may not qualify if:

• Presence of systemic or neurological disease capable of causing balance disorder,
• Postural hypotension,
• Presence of cardiovascular or musculoskeletal system disease capable of affecting locomotion,
• Presence of advanced dementia or mental disability

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Elif Yakşi

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Elif Yakşi, MD

  Abant İzzet Baysal University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: We have two groups. First group received biofeedback exercise and conventional exercise group, second group received only conventional exercise treatment

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 9, 2021
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 20, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

TU (1)