Parkinson DiseaseNCT03939559
The Efficiency of Home Based Dual Task Training in Parkinson Disease
A study testing Static, dynamic and functional balance exercises and Static, dynamic and functional balance exercises with dual task in people with Parkinson Disease, run by Istanbul University - Cerrahpasa.
Trial summary
The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Static, dynamic and functional balance exercises and Static, dynamic and functional balance exercises with dual task
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2019to 10 Feb 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 1-3 levels according to Hoehn Yahr scale
- Have 3 or fewer scores in the Freezing of Gait Questionnaire
- Obtain at least 24 points from the Mini Mental State Assessment test
- Independent walking on a flat surface without an auxiliary device
Who cannot join
- Serious hearing or vision problems
- Have any cardiac or orthopedic disorder that may prevent walking be
- Any other neurological disorder (eg, dementia, cerebrovascular disease)
- To have a level of education of less than 5 years.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki.
Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and will be given DVD copies with weekly recordings. The time and activity schedule created at the end of the brochures will be required to record daily home exercises of the patients. In the balance exercises group; static, dynamic and functional balance exercise packages will be taught in Parkinson 's disease. In the dual task based balance exercises group; motor or cognitive dual task training will be combined these static dynamic and functional balance exercises. In both groups, exercises will be performed 3 days a week for 8 weeks.
Read the detailed description
The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki.
Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and DVD copies where the exercises are recorded weekly. The time and activity schedule created at the end of the brochures, daily recording of home exercises of the patients will be requested. Home exercise training and assessments will be provided by different physiotherapists. The evaluator physiotherapist will be blind to the treatment group to which the patient belongs. In the balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session. In the dual task based balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session.
The number of subjects to be taken for each group in the 95% confidence interval was considered to be 26, considering the minimal clinical significant change (Minimal Clinically Important Difference, MCID) 3.5 for the Timed Up and Go Test. Considering that the patients did not continue treatment, it was decided to take 30 patients to each group and to carry out the study with a total of 60 patients. The primary outcomes are Mini Best Test,Timed Get Up and Go Test. Also objective datas will be obtained from Biodex Balance System, Wii Balance Board and G Walk Sensory Walking System.The secondary outcome measures include activity balance confidence scale, Parkinson's Disease Questionnaire-39 and cognitive tests such as number range test, verbal memory processes test, mental flexibility and word fluency test.
- Conditions
- Parkinson Disease
- Being tested
- Static, dynamic and functional balance exercises, Static, dynamic and functional balance exercises with dual task
- Keywords
- dual task, balance, postural control, rehabilitation, home-based exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static, dynamic and functional balance exercisesProcedure or surgery
In the first group (G1), 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks
Static, dynamic and functional balance exercises with dual taskProcedure or surgery
In the second group (G2), 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Balance Exercises Group | Experimental | Balance exercises group, 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session Receives: Procedure: Static, dynamic and functional balance exercises |
| Dual Task Based Balance Exercises Group | Experimental | Dual task based balance exercises group, 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks. Receives: Procedure: Static, dynamic and functional balance exercises with dual task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Best Test
The Mini-BEST test to be used for dynamic balance assessment is a 14-item balance scale and is a one-dimensional and highly reliable measurement method that requires approximately 15 minutes to complete.
Measured: 8 weeks
Wii Balance Board
With the Wii Balance Board (WDT), the patients' static balances will be evaluated.
The WDT includes a component similar to a typical force platform with four strain gauge based load sensors that can obtain data about changes in the pressure center and can be wirelessly connected to a computer via Bluetooth.
Measured: 8 weeks
Biodex Balance System
The Biodex Balance System (BBS; Biodex Medical System Inc., Shirley, NY, USA) will be used to measure the displacement of the foot pressure center (CoP).
Measured: 8 weeks
Timed Up and Go Test
Timed Up and Go Test is a simple, widely used and rapid test for assessing mobility, balance and fall risk
Measured: 8 weeks
Gait Assessment with G walk
Spatio temporal parameters of the gait are planned to be evaluated using the G-walk sensor.
Measured: 8 weeks
Secondary outcomes (6)
Activity Balance Confidence Scale
Activity-Specific Balance Confidence Scale will be used to measure patient's balance confidence. The ABC questionnaire, which is answered by an individual's self-perception of 16 items, measures the perceived ability of an individual on a 0-100 scale to achieve equilibrium under different conditions. This item is used to lead into each activity considered: "how confident are you that you will not lose your balance or become unsteady when you...". Each item is rated on a rating scale that ranges from 0-100. The highest score shows full confidence in the balance abilities. Overall score is calculated by adding item scores and then dividing by the total number of items.
Measured: 8 weeks
Parkinson Disease Questionnaire- 39
PDQ-39 is a self-report survey using the 5-point Likert scale to assess quality of life in Parkinson Disease. 39 multiple choice items covering 8 dimensions such as: mobility, activity of daily living (ADL), Emotional well-being, Stigma, Social Support, Cognition,Communication, Bodily Discomfort. All items are accepted to impact quality of life and must be answered to compute scores for each dimension. The responded items based on the experiences from the preceding month and 5 point ordinal scoring system (0:never, 1:occasionally, 2:sometimes, 3:often,4:always). Dimension scores are computed by the sum of scores of each item in the related dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Each dimension total score range from 0(never difficulty) to 100(always difficulty) and. Highest scores reflect worse quality of life. Overall score is the sum of dimension total scores divided by 8.
Measured: 8 weeks
Number Range Test
Number Range Test consists of two parts. The first part is the forward number range, the second part is the reverse number range. The two parts are applied separately. In both sections, the numbers are one by one. First, the advanced number range is applied. Then, the countdown range is applied. The numbers are read to the subject so that a number is read per second. In both the forward and backward range, the subject is passed to the next attempt at any successful attempt. If both attempts fail, the test is not continued. Creates a range of digits of the last repeatable sequence
Measured: 8 weeks
Verbal Memory Processes Test
The Verbal Memory Processes Test can distinguish many memory related parameters. The first of these; the instant memory of the person; the process of learning or acquiring knowledge, the third; remembering and recalling and remembering processes.
Measured: 8 weeks
Mental Flexibility Test
As part of the Mini-Mental State Assessment test, the output from 100 to 7 is done up to 65 (100, 93, 86, 79, 72, 65). Every correct transaction gets 1 point
Measured: 8 weeks
Word Fluency Test
F, A or S starting with the letter of the word or non-action words in as much as possible to say is based on a minute. Each letter is given 1 minute. The total score is all the words spoken in all letters. Measures verbal-phonological fluency. In the investigator's country, K, A, S letters were used in the standardization study. In this study, the total number of words will be taken into consideration.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start10 Jun 2019 (estimated)
- Primary completion10 Sep 2019 (estimated)
- Study completion10 Feb 2020 (estimated)
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 Istanbul University - CerrahpasaThe 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
- Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Ersoz Huseyinsinoglu, Istanbul University - Cerrahpasa
- Investigators
- Guzin Kaya Aytutuldu, MSc., Study chair, Yeditepe UniversityYonca Zenginler Yazgan, Assist.Prof., Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939559
- Sponsor's protocol ID
- İstanbulUCerrahpasa
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Home Based Dual Task Training in Parkinson Disease
- ClinicalTrials.gov ID
- NCT03939559
- Acronym / sponsor ID
- İstanbulUCerrahpasa
- Conditions
- Parkinson Disease
- Keywords
- dual task, balance, postural control, rehabilitation, home-based exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Jun 2019 (estimated)
- Primary completion
- 10 Sep 2019 (estimated)
- Study completion
- 10 Feb 2020 (estimated)
- First posted
- 7 May 2019 (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 investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki.
Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and will be given DVD copies with weekly recordings. The time and activity schedule created at the end of the brochures will be required to record daily home exercises of the patients. In the balance exercises group; static, dynamic and functional balance exercise packages will be taught in Parkinson 's disease. In the dual task based balance exercises group; motor or cognitive dual task training will be combined these static dynamic and functional balance exercises. In both groups, exercises will be performed 3 days a week for 8 weeks.
Detailed description
The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki.
Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and DVD copies where the exercises are recorded weekly. The time and activity schedule created at the end of the brochures, daily recording of home exercises of the patients will be requested. Home exercise training and assessments will be provided by different physiotherapists. The evaluator physiotherapist will be blind to the treatment group to which the patient belongs. In the balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session. In the dual task based balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session.
The number of subjects to be taken for each group in the 95% confidence interval was considered to be 26, considering the minimal clinical significant change (Minimal Clinically Important Difference, MCID) 3.5 for the Timed Up and Go Test. Considering that the patients did not continue treatment, it was decided to take 30 patients to each group and to carry out the study with a total of 60 patients. The primary outcomes are Mini Best Test,Timed Get Up and Go Test. Also objective datas will be obtained from Biodex Balance System, Wii Balance Board and G Walk Sensory Walking System.The secondary outcome measures include activity balance confidence scale, Parkinson's Disease Questionnaire-39 and cognitive tests such as number range test, verbal memory processes test, mental flexibility and word fluency test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups.
| Arm | Type | Receives |
|---|---|---|
| Balance Exercises Group | Experimental | Procedure: Static, dynamic and functional balance exercisesBalance exercises group, 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session |
| Dual Task Based Balance Exercises Group | Experimental | Procedure: Static, dynamic and functional balance exercises with dual taskDual task based balance exercises group, 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with 1-3 levels according to Hoehn Yahr scale
- Have 3 or fewer scores in the Freezing of Gait Questionnaire
- Obtain at least 24 points from the Mini Mental State Assessment test
- Independent walking on a flat surface without an auxiliary device
Key exclusion criteria (4 listed)
- Serious hearing or vision problems
- Have any cardiac or orthopedic disorder that may prevent walking be
- Any other neurological disorder (eg, dementia, cerebrovascular disease)
- To have a level of education of less than 5 years.
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 |
|---|---|---|
| Static, dynamic and functional balance exercisesIn the first group (G1), 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks | Procedure or surgery | Balance Exercises Group |
| Static, dynamic and functional balance exercises with dual taskIn the second group (G2), 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks. | Procedure or surgery | Dual Task Based Balance Exercises Group |
Primary outcome
Mini Best Test
Time frame: 8 weeks
The Mini-BEST test to be used for dynamic balance assessment is a 14-item balance scale and is a one-dimensional and highly reliable measurement method that requires approximately 15 minutes to complete.
Wii Balance Board
Time frame: 8 weeks
With the Wii Balance Board (WDT), the patients' static balances will be evaluated. The WDT includes a component similar to a typical force platform with four strain gauge based load sensors that can obtain data about changes in the pressure center and can be wirelessly connected to a computer via Bluetooth.
Biodex Balance System
Time frame: 8 weeks
The Biodex Balance System (BBS; Biodex Medical System Inc., Shirley, NY, USA) will be used to measure the displacement of the foot pressure center (CoP).
Timed Up and Go Test
Time frame: 8 weeks
Timed Up and Go Test is a simple, widely used and rapid test for assessing mobility, balance and fall risk
Gait Assessment with G walk
Time frame: 8 weeks
Spatio temporal parameters of the gait are planned to be evaluated using the G-walk sensor.
6 secondary outcomes
Activity Balance Confidence Scale
Time frame: 8 weeks
Parkinson Disease Questionnaire- 39
Time frame: 8 weeks
Number Range Test
Time frame: 8 weeks
Verbal Memory Processes Test
Time frame: 8 weeks
Mental Flexibility Test
Time frame: 8 weeks
Word Fluency Test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No
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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.
Guzin Kaya Aytutuldu, MSc. study chair
Yeditepe University
Yonca Zenginler Yazgan, Assist.Prof. study chair
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing Static, dynamic and functional balance exercises and Static, dynamic and functional balance exercises with dual task in people with Parkinson Disease, run by Istanbul University - Cerrahpasa.
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 4 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: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burcu Ersoz Huseyinsinoglu, Assoc.Prof. (+905427274316, burcu.ersoz@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Best Test (time frame: 8 weeks). The study lists 5 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 14 May 2019.