Idiopathic Parkinson DiseaseNCT06390163
Effects of Sensory-Motor Integration Training in Patients with Idiopathic Parkinson's Disease
A study testing Sensory-Motor Integration Training in people with Idiopathic Parkinson Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this single blind randomized controlled trial is to investigate the effect of sensory-motor integration training on cognitive functions, balance and gait in patients with Parkinson Disease? The main questions it aims to answer are: Does sensory-motor integration training have an effect on balance in… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- Sensory-Motor Integration Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2024to 30 Oct 2024
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with idiopathic Parkinson's disease
- Being between the ages of 45-75
- Being between stage 2-3 according to the Modified Hoehn-Yahr Staging Scale
- Having a score > 21 on the Montreal Cognitive Assessment Scale
- Being literate in Turkish
- No drug or dose changes throughout the study.
- Not having participated in any physiotherapy or rehabilitation program in the last 6 months.
- Volunteering to participate in the study
Who cannot join
- Presence of other neurological diseases
- Presence of vision problems (that cannot be compensated with the correct lens) or vestibular disorders that may affect balance, other than symptoms related to Parkinson's disease.
- Serious comorbidities that affect balance and gait or cannot be controlled with life-threatening medication (Diabetes, Hypertension, Cardiopulmonary diseases)
- Long-term corticosteroid use
- Presence of orthopedic and systemic diseases that may affect participation in exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation the Effects of Sensory-Motor Integration Training on Cognitive Functions, Balance and Gait in Patients with Idiopathic Parkinson's Disease
The goal of this single blind randomized controlled trial is to investigate the effect of sensory-motor integration training on cognitive functions, balance and gait in patients with Parkinson Disease?
The main questions it aims to answer are:
- Does sensory-motor integration training have an effect on balance in patients with Parkinson Disease?
- Does sensory-motor integration training have an effect on cognitive functions in patients with Parkinson Disease?
- Does sensory-motor integration training have an effect on gait in patients with Parkinson Disease? Patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. Patients in the study group will receivesensory-motor integration training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. No additional recommendations will be given to individuals in either group.
Read the detailed description
40 patients will be included in the study. Patients who agree to participate in the study will be divided into two groups, study and control groups, by using a table of random numbers, ensuring that there are equal numbers of patients in each group. Demographic and clinical information of all patients participating in the study will be recorded. Montreal Cognitive Assessment Test and Modified Hoehn Yahr Staging Scale scores of all participants will be recorded by the neurologist and eligible patients will be included in the study. Evaluations to be applied to the groups within the scope of the study: Unified Parkinson Disease Rating Scale Part 3 , Static posturography measurement, Functional Reaching Test , Dynamic Gait Index , Rapid Mild Cognitive Impairment Screening, Stroop Test, Symbol Digit Modalities Test , Clock Drawing Test. Assessments will be made during the patients on period (approximately 60 minutes after medication intake). On the first day of the study, demographic information will be recorded in both groups and the patients participating in the study will be randomized. After randomization, patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. Patients in the study group will receive sensory-perceptual-motor training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. No additional recommendations will be given to individuals in either group. Patients will be excluded from the study if they participate in any physiotherapy and rehabilitation program during the study. Patients in both groups will be evaluated a total of 3 times: at the beginning of the study, at the end of the study (at week 8), and 4 weeks after the end of the study (at week 12).
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- Sensory-Motor Integration Training
- Keywords
- Balance, Gait, Cognitive Function, Sensory-perception-motor training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory-Motor Integration TrainingOther
An exercise chain consisting of motor tasks, sensory stimuli and cognitive tasks will be created. Each session will include at least 3 motor tasks, 3 sensory stimuli and 3 cognitive tasks selected according to the patient's condition.
| Study group | Role | What they receive |
|---|---|---|
| Sensory-motor Integration Training | Experimental | Patients in the study group will receive sensory-motor integration training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. Receives: Other: Sensory-Motor Integration Training |
| Standart Care | No intervention | Patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Posturography
It measures postural stability while standing statically and dynamically. The device has a computer-connected force platform that measures the vertical forces applied on the patients\' feet (center of pressure/COG) to measure the position of the center of gravity and postural control.
Measured: Baseline, week 8 and week 12
Modified Dynamic Gait Index
Index is used to evaluate and document the ability to respond to changing task demands during gait. An increase in the score indicates that the patient\'s walking ability is better.
Measured: Baseline, week 8 and week 12
Functional Reach Test
It is used to evaluate dynamic balance and anteroposterior stability. In the standing position, the arm is lifted 90° upwards and stretched forward as much as possible, without losing contact with the feet. Initially, the projection of the acromion and the 3rd metacarpal bone on the wall is marked. At the final point reached after reaching forward, the projection of the 3rd metacarpal bone on the wall is marked and the difference is calculated. In elderly individuals, there is a risk of falling if the reach distance is less than 25.4 cm, and there is a risk of serious falling if it is less than 15 cm.
Measured: Baseline, week 8 and week 12
Quick Mild Cognitive Impairment Screen
It consists of 6 subtests: orientation, registration, clock drawing, delayed recall, verbal fluency and logical memory. This has a high degree of sensitivity in detecting cognitive impairment. It is also quick to apply, taking 3 to 5 minutes. There are cutoff points that are adjusted for factors such as age and education level. The total score is 100, and a score below 62 points indicates cognitive impairment.
Measured: Baseline, week 8 and week 12
Symbol Digit Modalities Test
It is a test frequently used in clinics because it evaluates attention, visuo-spatial information processing speed and working memory. Test is based on matching meaningless geometric shapes with certain numbers. The first 10 symbols are considered trials. Then the test starts and the person gets points for the correct marking he makes within 90 seconds. The maximum score is 60. Turkish Standardization of the test battery containing the relevant test was made and permission was obtained from the relevant authors
Measured: Baseline, week 8 and week 12
Stroop Test
The Stroop Test, which also measures the ability to change perceptual setup and response under disruptive influence, information processing speed and attention (especially selective attention).Increasing time and error indicates lower cognitive level.
Measured: Baseline, week 8 and week 12
Clock Drawing Test
Clock drawing test is an easy, quickly applicable, paper-and-pencil test with high validity and reliability used to evaluate visual-motor functions, planning, sequencing and abstract thinking skills. The Shulmann method will be used for scoring and this method evaluates out of a total of 5 points. An increase in the score indicates a better cognitive level.
Measured: Baseline, week 8 and week 12
Movement Disorders Society Unified Parkinson's Disease Rating Scale - Part 3
It is the revised form developed in 1980, by the Movement Disorders Association in 2008. It is a revised version that will eliminate the uncertainties present in scale and include current scientific developments. The number of questions, which was 42 in scale, was increased to 50 , and questions with yes/no options were removed because they caused structural inconsistency, and all questions were scored between 0 and 4. In our study, only the 3rd Part, which includes the Motor examination, will be used.
Measured: Baseline, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start5 May 2024
- Primary completion20 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Seckinogullari Korkusuz, Hacettepe University
- Investigators
- Ayla Fil Balkan, Assoc.Prof, Study director, Hacettepe UniversitySüleyman Korkusuz, PhD, Study chair, Atılım UniversityAyşenur Özcan, MSc, Study chair, Çankırı Karatekin UniversityGül Yalçın Çakmaklı, Assoc.Prof., Study chair, Hacettepe UniversityÖznur Yiğit, Assisst.Prof, Study chair, Hacettepe UniversityBülent Elibol, Prof.Dr., Study chair, Hacettepe UniversityBüşra Seçkinoğulları Korkusuz, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390163
- Sponsor's protocol ID
- KA-23038
- Status last verified
- Dec 2024
- First submitted
- 1 Mar 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gandolfi M, Munari D, Geroin C, Gajofatto A, Benedetti MD, Midiri A, Carla F, Picelli A, Waldner A, Smania N. Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial. Mult Scler. 2015 Oct;21(11):1453-62. doi: 10.1177/1352458514562438. Epub 2015 Jan 12.
PubMed 25583852Taghizadeh G, Azad A, Kashefi S, Fallah S, Daneshjoo F. The effect of sensory-motor training on hand and upper extremity sensory and motor function in patients with idiopathic Parkinson disease. J Hand Ther. 2018 Oct-Dec;31(4):486-493. doi: 10.1016/j.jht.2017.08.001. Epub 2017 Nov 14.
PubMed 29150384
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Effects of Sensory-Motor Integration Training on Cognitive Functions, Balance and Gait in Patients with Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06390163
- Acronym / sponsor ID
- KA-23038
- Conditions
- Idiopathic Parkinson Disease
- Keywords
- Balance, Gait, Cognitive Function, Sensory-perception-motor training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 30 Apr 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.
The goal of this single blind randomized controlled trial is to investigate the effect of sensory-motor integration training on cognitive functions, balance and gait in patients with Parkinson Disease?
The main questions it aims to answer are:
- Does sensory-motor integration training have an effect on balance in patients with Parkinson Disease?
- Does sensory-motor integration training have an effect on cognitive functions in patients with Parkinson Disease?
- Does sensory-motor integration training have an effect on gait in patients with Parkinson Disease? Patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. Patients in the study group will receivesensory-motor integration training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. No additional recommendations will be given to individuals in either group.
Detailed description
40 patients will be included in the study. Patients who agree to participate in the study will be divided into two groups, study and control groups, by using a table of random numbers, ensuring that there are equal numbers of patients in each group. Demographic and clinical information of all patients participating in the study will be recorded. Montreal Cognitive Assessment Test and Modified Hoehn Yahr Staging Scale scores of all participants will be recorded by the neurologist and eligible patients will be included in the study. Evaluations to be applied to the groups within the scope of the study: Unified Parkinson Disease Rating Scale Part 3 , Static posturography measurement, Functional Reaching Test , Dynamic Gait Index , Rapid Mild Cognitive Impairment Screening, Stroop Test, Symbol Digit Modalities Test , Clock Drawing Test. Assessments will be made during the patients on period (approximately 60 minutes after medication intake). On the first day of the study, demographic information will be recorded in both groups and the patients participating in the study will be randomized. After randomization, patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. Patients in the study group will receive sensory-perceptual-motor training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. No additional recommendations will be given to individuals in either group. Patients will be excluded from the study if they participate in any physiotherapy and rehabilitation program during the study. Patients in both groups will be evaluated a total of 3 times: at the beginning of the study, at the end of the study (at week 8), and 4 weeks after the end of the study (at week 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory-motor Integration Training | Experimental | Other: Sensory-Motor Integration TrainingPatients in the study group will receive sensory-motor integration training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. |
| Standart Care | No intervention | –Patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being diagnosed with idiopathic Parkinson's disease
- Being between the ages of 45-75
- Being between stage 2-3 according to the Modified Hoehn-Yahr Staging Scale
- Having a score > 21 on the Montreal Cognitive Assessment Scale
- Being literate in Turkish
Key exclusion criteria (5 listed)
- Presence of other neurological diseases
- Presence of vision problems (that cannot be compensated with the correct lens) or vestibular disorders that may affect balance, other than symptoms related to Parkinson's disease.
- Serious comorbidities that affect balance and gait or cannot be controlled with life-threatening medication (Diabetes, Hypertension, Cardiopulmonary diseases)
- Long-term corticosteroid use
- Presence of orthopedic and systemic diseases that may affect participation in exercise
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 |
|---|---|---|
| Sensory-Motor Integration TrainingAn exercise chain consisting of motor tasks, sensory stimuli and cognitive tasks will be created. Each session will include at least 3 motor tasks, 3 sensory stimuli and 3 cognitive tasks selected according to the patient's condition. | Other | Sensory-motor Integration Training |
Primary outcome
Static Posturography
Time frame: Baseline, week 8 and week 12
It measures postural stability while standing statically and dynamically. The device has a computer-connected force platform that measures the vertical forces applied on the patients\' feet (center of pressure/COG) to measure the position of the center of gravity and postural control.
Modified Dynamic Gait Index
Time frame: Baseline, week 8 and week 12
Index is used to evaluate and document the ability to respond to changing task demands during gait. An increase in the score indicates that the patient\'s walking ability is better.
Functional Reach Test
Time frame: Baseline, week 8 and week 12
It is used to evaluate dynamic balance and anteroposterior stability. In the standing position, the arm is lifted 90° upwards and stretched forward as much as possible, without losing contact with the feet. Initially, the projection of the acromion and the 3rd metacarpal bone on the wall is marked. At the final point reached after reaching forward, the projection of the 3rd metacarpal bone on the wall is marked and the difference is calculated. In elderly individuals, there is a risk of falling if the reach distance is less than 25.4 cm, and there is a risk of serious falling if it is less than 15 cm.
Quick Mild Cognitive Impairment Screen
Time frame: Baseline, week 8 and week 12
It consists of 6 subtests: orientation, registration, clock drawing, delayed recall, verbal fluency and logical memory. This has a high degree of sensitivity in detecting cognitive impairment. It is also quick to apply, taking 3 to 5 minutes. There are cutoff points that are adjusted for factors such as age and education level. The total score is 100, and a score below 62 points indicates cognitive impairment.
Symbol Digit Modalities Test
Time frame: Baseline, week 8 and week 12
It is a test frequently used in clinics because it evaluates attention, visuo-spatial information processing speed and working memory. Test is based on matching meaningless geometric shapes with certain numbers. The first 10 symbols are considered trials. Then the test starts and the person gets points for the correct marking he makes within 90 seconds. The maximum score is 60. Turkish Standardization of the test battery containing the relevant test was made and permission was obtained from the relevant authors
Stroop Test
Time frame: Baseline, week 8 and week 12
The Stroop Test, which also measures the ability to change perceptual setup and response under disruptive influence, information processing speed and attention (especially selective attention).Increasing time and error indicates lower cognitive level.
Clock Drawing Test
Time frame: Baseline, week 8 and week 12
Clock drawing test is an easy, quickly applicable, paper-and-pencil test with high validity and reliability used to evaluate visual-motor functions, planning, sequencing and abstract thinking skills. The Shulmann method will be used for scoring and this method evaluates out of a total of 5 points. An increase in the score indicates a better cognitive level.
Movement Disorders Society Unified Parkinson's Disease Rating Scale - Part 3
Time frame: Baseline, week 8 and week 12
It is the revised form developed in 1980, by the Movement Disorders Association in 2008. It is a revised version that will eliminate the uncertainties present in scale and include current scientific developments. The number of questions, which was 42 in scale, was increased to 50 , and questions with yes/no options were removed because they caused structural inconsistency, and all questions were scored between 0 and 4. In our study, only the 3rd Part, which includes the Motor examination, will be used.
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 27 Dec 2024.
- Background: PubMed 25583852Gandolfi M, Munari D, Geroin C, Gajofatto A, Benedetti MD, Midiri A, Carla F, Picelli A, Waldner A, Smania N. Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial. Mult Scler. 2015 Oct;21(11):1453-62. doi: 10.1177/1352458514562438. Epub 2015 Jan 12.
- Background: PubMed 29150384Taghizadeh G, Azad A, Kashefi S, Fallah S, Daneshjoo F. The effect of sensory-motor training on hand and upper extremity sensory and motor function in patients with idiopathic Parkinson disease. J Hand Ther. 2018 Oct-Dec;31(4):486-493. doi: 10.1016/j.jht.2017.08.001. Epub 2017 Nov 14.
- 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.
Ayla Fil Balkan, Assoc.Prof study director
Hacettepe University
Süleyman Korkusuz, PhD study chair
Atılım University
Ayşenur Özcan, MSc study chair
Çankırı Karatekin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory-Motor Integration Training in people with Idiopathic Parkinson Disease, run by Hacettepe 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 8 inclusion and 5 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 27 Dec 2024. 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?
Static Posturography (time frame: Baseline, week 8 and week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06390163, which also lists 2 linked publications.
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 27 Dec 2024.