Clinical trial NCT04997213: Biofeedback Balance Exercises in Parkinson's Disease
Official title: Effects of Classical Balance-Coordination Exercises and Static Posturography Device Assisted Feedback Exercises on Fall Risk and Balance-Coordination Parameters in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Balance; Distorted
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We have two groups. First group received biofeedback exercise and conventional exercise group, second group received only conventional exercise treatment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Hoehn and Yahr Scale
timeFrame: Baseline
measure: The Movement Disorder Society Unified Parkinson's Disease rating Scale
timeFrame: Baseline
measure: The Movement Disorder Society Unified Parkinson's Disease rating Scale
timeFrame: 6 weeks
measure: Tinetti Balance and Gait Assessment
timeFrame: Baseline
measure: Tinetti Balance and Gait Assessment
timeFrame: 6 weeks
measure: Berg Balance Scale
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: Timed Up and Go Test
timeFrame: Baseline
measure: Timed Up and Go Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Tandem Stance Test
timeFrame: Baseline
measure: Tandem Stance Test
timeFrame: 6 weeks
measure: Health Assessment Questionnaire
timeFrame: Baseline
measure: Health Assessment Questionnaire
timeFrame: 6 weeks
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Elif Yakşi
Study officials:
affiliation: Abant İzzet Baysal University Medical Faculty
name: Elif Yakşi, MD
role: PRINCIPAL_INVESTIGATOR
References: