Biofeedback Balance Exercises in Parkinson's Disease

NCT ID: NCT04997213

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-06-20

Brief Summary

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

Detailed Description

Parkinson's disease (PD) is a chronic, progressive, degenerative movement disorder, the incidence of which increases with age, characterized by motor and non-motor findings. Cardinal motor findings such as bradykinesia, rigidity, rest tremor, postural instability, and gait dysfunction and secondary motor symptoms additional to these such as dysarthria, and associated movements in the arms may be seen throughout the course of the disease. Progressive loss of dopaminergic neurons occurs in the basal ganglia, together with a decrease in the speed and angle of movement. Loss of postural reflexes causes balance disturbance findings such as impaired postural control, rigidity in the extremities, and akinesia.Falls, decreased mobility, disability and quality of life impairment occur as a result of balance disorder. Higher rates of falls or fall-related fractures have been reported in PD compared to the non-PD elderly population.There are several exercise applications aimed at balance improving strategies in PD. Strengthening exercises combined with conventional balance exercises, treadmill walking training, tai chi, and biofeedback have been shown to improve gait and and balance control in PD. Various publications have shown that biofeedback therapy in elderly individuals and in healthy individuals with postural disorder exhibits positive effects on balance by enhancing postural stability and reducing body tremor. The basic aim of this study was to investigate the effects of static posturography-assisted visual and auditory biofeedback therapy on balance and the risk of falls in PD. In addition, the study was intended to determine the effects of balance training on the individual's daily living activities, perceived safety level, and emotional state.

Conditions

Parkinson Disease; Balance; Distorted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional group

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.

Group Type: EXPERIMENTAL

Biofeedback exercises

Intervention Type: 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.

Conventional Exercises

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Conventional Exercises

Intervention Type: 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.

Interventions

Biofeedback exercises

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.

Intervention Type: OTHER

Conventional Exercises

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Elif yaksi

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elif Yakşi, MD

Role: PRINCIPAL_INVESTIGATOR

Abant İzzet Baysal University Medical Faculty

Locations

Elif Yakşi

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-FTR-EY-05

Identifier Type: -

Identifier Source: org_study_id