Parkinson DiseaseNCT06615115
The Effect of Different Types of Focus Instructions in Parkinson's Rehabilitation
A study testing Exercise in people with Parkinson Disease and Cognitive Deficit in Attention, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Cognitive Deficit in Attention, Feedback, Psychological
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hoehn and Yahr Stage II or III
- Individuals between the ages of 50 and 70 who can walk independently but have balance disorders
- Having a score between 21-56 on the Berg Balance Scale
- Having a score between 24-30 on the Mini Mental State Test
- Having agreed to participate in the study (Not having a freezing phenomenon)
- Being in the Medication-on period
Who cannot join
- Having malignancy and metabolic diseases
- Having had Cerebrovascular Accident before
- Other neurological disease history
- Presence of cognitive problems
- Presence of visual or hearing disorders
- Presence of deep brain pacemaker
- Presence of freezing phenomenon (persons with Freezing of Gait Questionnaire FOG-Q above zero)
- Presence of dyskinesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atafiz Tıp Merkezi
Istanbul, 34636
Leyla Koçak, PT, +05334029807, leyla.kocak2803@hotmail.com
İsmail Muştu, PT, +02165759444 ext. 9444, mustuismail@gmail.com
About this study
Official title: Effects of an External and Combined Focus of Attention-Instructed Exercise Program on Postural Stability and Dual-Task Walking in Parkinson's Disease: A Randomized, Assessor-Blinded, Controlled Trial
Parkinson's disease is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increases their quality of life. Recently, various additional methods have been developed to increase the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention has been shown to facilitate motor function development, reduce postural instability, and improve dual-task walking by being easier to remember. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients. This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, taking into account the presence of freezing phenomena in Parkinson's patients.
Read the detailed description
Parkinson's disease (PD) is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Such deficits are associated with the acquisition of motor function skills. Although PD patients are open to learning, they experience challenges with motor planning. Therefore, individuals with PD may require additional training, sensory input, and motor education for the permanence and ease of motor skill acquisition.
The difficulties PD patients face with complex commands indicate that they can learn in a feedforward manner, but they show inconsistencies in the use of automatic functions. This inconsistency results in challenges in adapting to variable situations and performing complex activities (like balance and walking). Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increasing their quality of life. Recently, various additional methods have been developed to enhance the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. One commonly used method to address deficits in motor behavior is motor learning activities, which involve repetitive movements and ensure continuity.
Many studies have shown that the concept of focus of attention contributes to the efficiency and learning of various motor functions, particularly balance. Individuals with Parkinson's are highly receptive to external stimuli, so a focus-based strategy during balance and walking training can improve these skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention facilitates motor function development, reduces postural instability, and improves dual-task walking. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients.
This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, considering the presence of freezing phenomena in Parkinson's patients. Approximately 48 individuals with Parkinson's disease without freezing phenomena will participate in an exercise program for six weeks, three days a week. Participants will be randomized into a combined focus group, an external focus group, and a control group. Assessments will be repeated at the beginning and end of the six-week exercise program.
- Conditions
- Parkinson Disease, Cognitive Deficit in Attention, Feedback, Psychological, Gait, Festinating
- Being tested
- Exercise
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
All participants will perform a total body stretching exercise for 10 minutes, followed by 10 minutes of obstacle course navigation, 10 minutes of balance training (including tandem walking, balance board exercises, single-leg balance, and two-legged reaching exercises), and will conclude with 10 minutes of strength training exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group1: Exercises with External Attention Focus Instructions | Experimental | Throughout the descriped exercise program, the physiotherapist will guide the participants using only external focus of attention instructions.
Example: Go over the red block. (10 rounds ) Receives: Other: Exercise |
| Group 2: Exercises with Combined Attention Focus Instructions | Experimental | The exercise program given to the External Focus of Attention group will also be administered to this group. While guiding the exercises, the physiotherapist will use a combination of both external and internal focus of attention instructions to direct the participants.
Example: Pass over the red block by pulling your knees up as high as you can. Receives: Other: Exercise |
| Grup 3: Exercises with no instructions (Control Group) | Experimental | The same exercise program given to the other groups will also be administered to this group but no instruction will be given to this group.
Example: Take 10 turn around the track, passing over the blocks Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
This is a 14-item scale that measures the ability to maintain balance during dynamic tasks. It is rated on a scale of 0 to 4 points, with a maximum total score of 56. As the total score decreases, the risk of falling increases.
0 to 20 points: Indicates that the individual is dependent on a wheelchair and has a 100% risk of falling. 21 to 40 points: Suggests that the individual has a moderate risk of falling and may be able to walk with assistance. 41 to 56 points: Indicates that the individual can ambulate independently with a low risk of falling.
Measured: baseline, six weeks after the baseline
Time Up and Go Dual Task
The test assesses balance, walking, and functionality during activities. The TUG-Dual Task evaluates walking abilities and attention management by asking participants to solve a simple math problem or perform another cognitive task while walking. Patients will be assessed for functionality, walking speeds, and balance evaluations. If the duration lasts more than 12 seconds, there is a risk of falling.
Measured: baseline, six weeks after the baseline
Secondary outcomes (1)
The Parkinson's Disease Questionnaire-39 (PDQ-39)
The PDQ-39 is a PD specific health status questionnaire comprising 39 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100¼more health problems).
Measured: baseline, six weeks after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start30 Jan 2025
- Primary completion30 May 2025 (estimated)
- Study completion30 Dec 2025 (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.
- 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
- Participants who meet the inclusion criteria will be randomized into external focus of attention, combined focus of attention, and control groups. The same exercise program will be administered to all three groups by the same physiotherapist. The exercise program will last for 6 weeks, with sessions held three times a week. Although the exercises will be the same, the instructions given to the patients will vary by group. Assessments will be repeated at the beginning of treatment and at the end of the 6th week by a blinded evaluator.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Pişirici, Bahçeşehir University
- Investigators
- Leyla Koçak, PT, Principal investigator, Bahcesehir University, Faculty of Health Sciences, Department of PhysiotherapyPelin Pişirici, PT, PhD, Study director, Bahcesehir University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615115
- Sponsor's protocol ID
- LPar24
- Status last verified
- Feb 2025
- First submitted
- 24 Sep 2024
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an External and Combined Focus of Attention-Instructed Exercise Program on Postural Stability and Dual-Task Walking in Parkinson's Disease: A Randomized, Assessor-Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT06615115
- Acronym / sponsor ID
- LPar24
- Conditions
- Parkinson Disease, Cognitive Deficit in Attention, Feedback, Psychological, Gait, Festinating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Sep 2024 (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.
Parkinson's disease is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increases their quality of life. Recently, various additional methods have been developed to increase the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention has been shown to facilitate motor function development, reduce postural instability, and improve dual-task walking by being easier to remember. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients. This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, taking into account the presence of freezing phenomena in Parkinson's patients.
Detailed description
Parkinson's disease (PD) is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Such deficits are associated with the acquisition of motor function skills. Although PD patients are open to learning, they experience challenges with motor planning. Therefore, individuals with PD may require additional training, sensory input, and motor education for the permanence and ease of motor skill acquisition.
The difficulties PD patients face with complex commands indicate that they can learn in a feedforward manner, but they show inconsistencies in the use of automatic functions. This inconsistency results in challenges in adapting to variable situations and performing complex activities (like balance and walking). Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increasing their quality of life. Recently, various additional methods have been developed to enhance the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. One commonly used method to address deficits in motor behavior is motor learning activities, which involve repetitive movements and ensure continuity.
Many studies have shown that the concept of focus of attention contributes to the efficiency and learning of various motor functions, particularly balance. Individuals with Parkinson's are highly receptive to external stimuli, so a focus-based strategy during balance and walking training can improve these skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention facilitates motor function development, reduces postural instability, and improves dual-task walking. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients.
This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, considering the presence of freezing phenomena in Parkinson's patients. Approximately 48 individuals with Parkinson's disease without freezing phenomena will participate in an exercise program for six weeks, three days a week. Participants will be randomized into a combined focus group, an external focus group, and a control group. Assessments will be repeated at the beginning and end of the six-week exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants who meet the inclusion criteria will be randomized into external focus of attention, combined focus of attention, and control groups. The same exercise program will be administered to all three groups by the same physiotherapist. The exercise program will last for 6 weeks, with sessions held three times a week. Although the exercises will be the same, the instructions given to the patients will vary by group. Assessments will be repeated at the beginning of treatment and at the end of the 6th week by a blinded evaluator.
| Arm | Type | Receives |
|---|---|---|
| Group1: Exercises with External Attention Focus Instructions | Experimental | Other: ExerciseThroughout the descriped exercise program, the physiotherapist will guide the participants using only external focus of attention instructions. Example: Go over the red block. (10 rounds ) |
| Group 2: Exercises with Combined Attention Focus Instructions | Experimental | Other: ExerciseThe exercise program given to the External Focus of Attention group will also be administered to this group. While guiding the exercises, the physiotherapist will use a combination of both external and internal focus of attention instructions to direct the participants. Example: Pass over the red block by pulling your knees up as high as you can. |
| Grup 3: Exercises with no instructions (Control Group) | Experimental | Other: ExerciseThe same exercise program given to the other groups will also be administered to this group but no instruction will be given to this group. Example: Take 10 turn around the track, passing over the blocks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hoehn and Yahr Stage II or III
- Individuals between the ages of 50 and 70 who can walk independently but have balance disorders
- Having a score between 21-56 on the Berg Balance Scale
- Having a score between 24-30 on the Mini Mental State Test
- Having agreed to participate in the study (Not having a freezing phenomenon)
Key exclusion criteria (8 listed)
- Having malignancy and metabolic diseases
- Having had Cerebrovascular Accident before
- Other neurological disease history
- Presence of cognitive problems
- Presence of visual or hearing disorders
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 |
|---|---|---|
| ExerciseAll participants will perform a total body stretching exercise for 10 minutes, followed by 10 minutes of obstacle course navigation, 10 minutes of balance training (including tandem walking, balance board exercises, single-leg balance, and two-legged reaching exercises), and will conclude with 10 minutes of strength training exercises. | Other | Group 2: Exercises with Combined Attention Focus Instructions, Group1: Exercises with External Attention Focus Instructions, Grup 3: Exercises with no instructions (Control Group) |
Primary outcome
Berg Balance Scale
Time frame: baseline, six weeks after the baseline
This is a 14-item scale that measures the ability to maintain balance during dynamic tasks. It is rated on a scale of 0 to 4 points, with a maximum total score of 56. As the total score decreases, the risk of falling increases. 0 to 20 points: Indicates that the individual is dependent on a wheelchair and has a 100% risk of falling. 21 to 40 points: Suggests that the individual has a moderate risk of falling and may be able to walk with assistance. 41 to 56 points: Indicates that the individual can ambulate independently with a low risk of falling.
Time Up and Go Dual Task
Time frame: baseline, six weeks after the baseline
The test assesses balance, walking, and functionality during activities. The TUG-Dual Task evaluates walking abilities and attention management by asking participants to solve a simple math problem or perform another cognitive task while walking. Patients will be assessed for functionality, walking speeds, and balance evaluations. If the duration lasts more than 12 seconds, there is a risk of falling.
1 secondary outcome
The Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: baseline, six weeks after the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- 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.
Leyla Koçak, PT principal investigator
Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy
Pelin Pişirici, PT, PhD study director
Bahcesehir University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson Disease and Cognitive Deficit in Attention, run by Bahçeşehir 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pelin Pişirici, PT, PhD (05055016076, pelinpisirici@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: baseline, six weeks after the baseline). The study lists 2 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 11 Feb 2025.