Parkinson DiseaseNCT04997213
Biofeedback Balance Exercises in Parkinson's Disease
A study testing Biofeedback exercises and Conventional Exercises in people with Parkinson Disease and Balance; Distorted, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effectiveness of static posturography-assisted biofeedback exercises in PD-related balance disorder. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Balance; Distorted
- What is being tested?
- Biofeedback exercises and Conventional Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease,
- Age 40 - 85
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The aim of this study was to evaluate the effectiveness of static posturography-assisted biofeedback exercises in PD-related balance disorder.
Read the 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
- Being tested
- Biofeedback exercises, Conventional Exercises
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback exercisesOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (6)
Tandem Stance Test
Tandem stance is a clinical measurement used to assess postural stability and standing balance in a heel-to-toe position on a narrow base of support with a temporal measurement. The individual's ability to maintain static balance is recorded in seconds
Measured: Baseline
Tandem Stance Test
Tandem stance is a clinical measurement used to assess postural stability and standing balance in a heel-to-toe position on a narrow base of support with a temporal measurement. The individual's ability to maintain static balance is recorded in seconds
Measured: 6 weeks
Health Assessment Questionnaire
This questionnaire consists of eight questions designed to assess the effects of individuals' health status on daily living. Day-to-day activities such as dressing, hygiene, eating, and walking are assessed, and high scores indicate poor health status.
Measured: Baseline
Health Assessment Questionnaire
This questionnaire consists of eight questions designed to assess the effects of individuals' health status on daily living. Day-to-day activities such as dressing, hygiene, eating, and walking are assessed, and high scores indicate poor health status.
Measured: 6 weeks
Beck Depression Inventory
The BDI is used to evaluate physical, emotional, and cognitive symptoms encountered in depression, such as hopelessness, irritability, guilt, fatigue, and weight loss. Scoring is performed from absence of symptoms to severe symptoms. Total scores range between 0 (no depression) and 63 (severe depression).
Measured: Baseline
Beck Depression Inventory
The BDI is used to evaluate physical, emotional, and cognitive symptoms encountered in depression, such as hopelessness, irritability, guilt, fatigue, and weight loss. Scoring is performed from absence of symptoms to severe symptoms. Total scores range between 0 (no depression) and 63 (severe depression).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We have two groups. First group received biofeedback exercise and conventional exercise group, second group received only conventional exercise treatment
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif yaksi, Abant Izzet Baysal University
- Investigators
- Elif Yakşi, MD, Principal investigator, Abant İzzet Baysal University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997213
- Sponsor's protocol ID
- AIBU-FTR-EY-05
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04997213
- Acronym / sponsor ID
- AIBU-FTR-EY-05
- Conditions
- Parkinson Disease, Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We have two groups. First group received biofeedback exercise and conventional exercise group, second group received only conventional exercise treatment
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Biofeedback exercises, Other: Conventional ExercisesBiofeedback 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. |
| Control group | Active comparator | Other: Conventional ExercisesClassic 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Parkinson's disease,
- Age 40 - 85
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback exercisesBiofeedback 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. | Other | Interventional group |
| Conventional ExercisesClassic 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. | Other | Control group, Interventional group |
Primary outcome
The Hoehn and Yahr Scale
Time frame: Baseline
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).
The Movement Disorder Society Unified Parkinson's Disease rating Scale
Time frame: Baseline
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.
The Movement Disorder Society Unified Parkinson's Disease rating Scale
Time frame: 6 weeks
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.
Tinetti Balance and Gait Assessment
Time frame: Baseline
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
Tinetti Balance and Gait Assessment
Time frame: 6 weeks
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
Berg Balance Scale
Time frame: Baseline
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
Berg Balance Scale
Time frame: 6 weeks
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
Timed Up and Go Test
Time frame: Baseline
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.
Timed Up and Go Test
Time frame: 6 weeks
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 secondary outcomes
Tandem Stance Test
Time frame: Baseline
Tandem Stance Test
Time frame: 6 weeks
Health Assessment Questionnaire
Time frame: Baseline
Health Assessment Questionnaire
Time frame: 6 weeks
Beck Depression Inventory
Time frame: Baseline
Beck Depression Inventory
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Yakşi, MD principal investigator
Abant İzzet Baysal University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback exercises and Conventional Exercises in people with Parkinson Disease and Balance; Distorted, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hoehn and Yahr Scale (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.