Parkinson's Disease (PD)NCT07872202
To Assess Self-sufficiency in Parkinson's Patients and How Rehabilitation Affects Symptoms Linked to Independence
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Parkinson's Disease (PD), run by Palacky University at 1 site in Czechia.
Trial summary
This interventional study aims to assess self-sufficiency in patients with Parkinson's disease in the spa setting using the new Czech Functional Efficiency of Self-sufficiency Test (FEST) and to validate the test in this population. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2024to 1 Mar 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD,
- severity level 1 - 3 according to the Hoehn and Yahr scale,
- age 50-80 years,
- the ability to walk independently,
- a minimum score of ≤76 on the Adenbrooke's Cognitive Test.
Who cannot join
- moderate to severe dementia,
- other comorbidities affecting the gait (e.g. post-stroke condition, vertigo,...), psychiatric disorders,
- severe sensory impairments that would limit the implementation of the rehabilitation plan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences, Palacky University, Olomouc
Olomouc, 775 15
Zuzana Turiaková, Mgr. (MSc.), +420724331263, zuzana.turiakova01@upol.cz
About this study
Official title: Assessment of Patient Self-sufficiency in Rehabilitation Care
This interventional study aims to assess self-sufficiency in patients with Parkinson's disease in the spa setting using the new Czech Functional Efficiency of Self-sufficiency Test (FEST) and to validate the test in this population. It also aims to evaluate changes in cognition, stability, fear of falling, and gait after specialized spa care and to analyze correlations between self-sufficiency and these outcomes.
Read the detailed description
The research includes the validation of a Czech self-sufficiency test designed primarily for patients after a stroke. The aim is to validate this tool in patients with Parkinson's disease (PD). The research will also include the possible modification of certain categories that are characteristic of PD patients, as well as the scoring of the test. The study will include patients undergoing comprehensive spa treatment at a Czech spa facility. The inclusion criteria are: 1/idiopathic PD, 2/disease severity 1-3 according to the Hoehn and Yahr scale, 3/age 50-80 years, 4/ability to walk independently, 5/minimum score ≤76 in Adenbrooke's Cognitive Examination. Exclusion criteria: 1/moderate to severe dementia, 2/other comorbidities affecting the gait (e.g. post-stroke condition, vertigo,...), 3/psychiatric disorders, 4/severe sensory impairments that would limit the implementation of the rehabilitation plan. The research will also evaluate changes in selected parameters, namely: cognition, stability, gait, and fear of falling. The research will also examine whether there is a correlation between self-sufficiency and these factors. Patients will be tested upon admission to care, then undergo a 3-week rehabilitation program, followed by a follow-up measurement.
Standardized tests were selected for research purposes:
Self-sufficiency: Barthel Index, FEST Fear of falling: Short Falls Efficacy Scale - International Stability: Mini-Balance Evaluation Systems Test, measurement on a stabilometric platform Cognition: Adenbrooke's Cognitive Examination (ACE-III) Gait: 6-minute walk test Descriptive statistics and correlation will be used for data processing.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Keywords
- Parkinson's disease, self-sufficiency, spa care, rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther
Also called Active exercising, rehabilitation care
Patients undergo therapies led by clinical experts in the field of physical therapy. Individual therapies include soft tissue therapies, exercises aimed at increasing/maintaining range of motion, increasing muscle strength, balance, cognition, and self-sufficiency. The comprehensive rehabilitation stay will also include the use of natural healing resources - iodine-bromine brine, combined with active therapy.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Experimental | Patients with Parkinson's disease undergo comprehensive spa treatment, which includes: individual therapeutic physical education, group exercises - exercises on balance balls, exercises in the pool, balance training on Nintendo Wii, Nordic walking, Qi Gong. In addition to active therapy, the treatment also utilizes the effects of natural resources on the body - iodine-bromine water in the form of compresses and baths, massages - aromatherapy, classic massages. Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Sufficiency Test Score
Change in the total score of the Functional Efficiency of Self-Sufficiency Test from baseline to completion of the rehabilitation program. The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence.
Unit of measure:
points
Measurement tool:
Functional Efficiency of Self-Sufficiency Test
Measured: 3 weeks
Change in Addenbrooke's Cognitive Examination III (ACE-III) Score
Change in the total Addenbrooke's Cognitive Examination III (ACE-III) score from baseline to completion of the rehabilitation program. The ACE-III total score ranges from 0 to 100 points, with higher scores indicating better cognitive performance.
Unit of measure:
points
Measurement tool:
Addenbrooke's Cognitive Examination III (ACE-III)
Measured: 3 weeks
Change in Short Falls Efficacy Scale-International (Short FES-I) Score
Change in the total Short Falls Efficacy Scale-International (Short FES-I) score from baseline to completion of the rehabilitation program. The total score ranges from 7 to 28 points, with higher scores indicating greater concern about falling.
Unit of measure:
points
Measurement tool:
Short Falls Efficacy Scale-International (Short FES-I)
Measured: 3 weeks
Change in Mini-BESTest Score
Change in the total Mini-Balance Evaluation Systems Test (Mini-BESTest) score from baseline to completion of the rehabilitation program. The total score ranges from 0 to 28 points, with higher scores indicating better dynamic balance.
Unit of measure:
points
Measurement tool:
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Measured: 3 weeks
Change in Weight-Bearing Asymmetry Measured Using a Force Platform
Change in weight-bearing asymmetry during 30-second quiet standing from baseline to completion of the rehabilitation program, measured using a force platform. Weight-bearing asymmetry is expressed as the absolute difference between the percentage load on the left and right sides. Lower values indicate more symmetrical weight distribution.
Unit of measure:
percentage points
Measurement tool:
Force platform
Measured: 3 weeks
Change in Six-Minute Walk Test Distance
Change in the distance walked during the Six-Minute Walk Test (6MWT) from baseline to completion of the rehabilitation program. A greater walking distance indicates better functional exercise capacity.
Unit of measure:
meters (m)
Measurement tool:
Six-Minute Walk Test (6MWT)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuzana Turiakova, Palacky University
- Investigators
- Helena Kisvetrová, Ass.Prof., Principal investigator, Doctoral Study Office, Faculty of Health Sciences, Palacky University, Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872202
- Sponsor's protocol ID
- Dissertation
- Status last verified
- Jan 2026
- First submitted
- 28 Jun 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Self-sufficiency in Rehabilitation Care
- ClinicalTrials.gov ID
- NCT07872202
- Acronym / sponsor ID
- Dissertation
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's disease, self-sufficiency, spa care, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
This interventional study aims to assess self-sufficiency in patients with Parkinson's disease in the spa setting using the new Czech Functional Efficiency of Self-sufficiency Test (FEST) and to validate the test in this population. It also aims to evaluate changes in cognition, stability, fear of falling, and gait after specialized spa care and to analyze correlations between self-sufficiency and these outcomes.
Detailed description
The research includes the validation of a Czech self-sufficiency test designed primarily for patients after a stroke. The aim is to validate this tool in patients with Parkinson's disease (PD). The research will also include the possible modification of certain categories that are characteristic of PD patients, as well as the scoring of the test. The study will include patients undergoing comprehensive spa treatment at a Czech spa facility. The inclusion criteria are: 1/idiopathic PD, 2/disease severity 1-3 according to the Hoehn and Yahr scale, 3/age 50-80 years, 4/ability to walk independently, 5/minimum score ≤76 in Adenbrooke's Cognitive Examination. Exclusion criteria: 1/moderate to severe dementia, 2/other comorbidities affecting the gait (e.g. post-stroke condition, vertigo,...), 3/psychiatric disorders, 4/severe sensory impairments that would limit the implementation of the rehabilitation plan. The research will also evaluate changes in selected parameters, namely: cognition, stability, gait, and fear of falling. The research will also examine whether there is a correlation between self-sufficiency and these factors. Patients will be tested upon admission to care, then undergo a 3-week rehabilitation program, followed by a follow-up measurement.
Standardized tests were selected for research purposes:
Self-sufficiency: Barthel Index, FEST Fear of falling: Short Falls Efficacy Scale - International Stability: Mini-Balance Evaluation Systems Test, measurement on a stabilometric platform Cognition: Adenbrooke's Cognitive Examination (ACE-III) Gait: 6-minute walk test Descriptive statistics and correlation will be used for data processing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | Experimental | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONPatients with Parkinson's disease undergo comprehensive spa treatment, which includes: individual therapeutic physical education, group exercises - exercises on balance balls, exercises in the pool, balance training on Nintendo Wii, Nordic walking, Qi Gong. In addition to active therapy, the treatment also utilizes the effects of natural resources on the body - iodine-bromine water in the form of compresses and baths, massages - aromatherapy, classic massages. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic PD,
- severity level 1 - 3 according to the Hoehn and Yahr scale,
- age 50-80 years,
- the ability to walk independently,
- a minimum score of ≤76 on the Adenbrooke's Cognitive Test.
Key exclusion criteria (3 listed)
- moderate to severe dementia,
- other comorbidities affecting the gait (e.g. post-stroke condition, vertigo,...), psychiatric disorders,
- severe sensory impairments that would limit the implementation of the rehabilitation plan.
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 |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAlso: Active exercising, rehabilitation carePatients undergo therapies led by clinical experts in the field of physical therapy. Individual therapies include soft tissue therapies, exercises aimed at increasing/maintaining range of motion, increasing muscle strength, balance, cognition, and self-sufficiency. The comprehensive rehabilitation stay will also include the use of natural healing resources - iodine-bromine brine, combined with active therapy. | Other | Parkinson's disease patients |
Primary outcome
Change in Self-Sufficiency Test Score
Time frame: 3 weeks
Change in the total score of the Functional Efficiency of Self-Sufficiency Test from baseline to completion of the rehabilitation program. The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence. Unit of measure: points Measurement tool: Functional Efficiency of Self-Sufficiency Test
Change in Addenbrooke's Cognitive Examination III (ACE-III) Score
Time frame: 3 weeks
Change in the total Addenbrooke's Cognitive Examination III (ACE-III) score from baseline to completion of the rehabilitation program. The ACE-III total score ranges from 0 to 100 points, with higher scores indicating better cognitive performance. Unit of measure: points Measurement tool: Addenbrooke's Cognitive Examination III (ACE-III)
Change in Short Falls Efficacy Scale-International (Short FES-I) Score
Time frame: 3 weeks
Change in the total Short Falls Efficacy Scale-International (Short FES-I) score from baseline to completion of the rehabilitation program. The total score ranges from 7 to 28 points, with higher scores indicating greater concern about falling. Unit of measure: points Measurement tool: Short Falls Efficacy Scale-International (Short FES-I)
Change in Mini-BESTest Score
Time frame: 3 weeks
Change in the total Mini-Balance Evaluation Systems Test (Mini-BESTest) score from baseline to completion of the rehabilitation program. The total score ranges from 0 to 28 points, with higher scores indicating better dynamic balance. Unit of measure: points Measurement tool: Mini-Balance Evaluation Systems Test (Mini-BESTest)
Change in Weight-Bearing Asymmetry Measured Using a Force Platform
Time frame: 3 weeks
Change in weight-bearing asymmetry during 30-second quiet standing from baseline to completion of the rehabilitation program, measured using a force platform. Weight-bearing asymmetry is expressed as the absolute difference between the percentage load on the left and right sides. Lower values indicate more symmetrical weight distribution. Unit of measure: percentage points Measurement tool: Force platform
Change in Six-Minute Walk Test Distance
Time frame: 3 weeks
Change in the distance walked during the Six-Minute Walk Test (6MWT) from baseline to completion of the rehabilitation program. A greater walking distance indicates better functional exercise capacity. Unit of measure: meters (m) Measurement tool: Six-Minute Walk Test (6MWT)
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 13 Oct 2026.
- 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.
Helena Kisvetrová, Ass.Prof. principal investigator
Doctoral Study Office, Faculty of Health Sciences, Palacky University, Olomouc
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 TRAINING WITH OR WITHOUT MEDICATION in people with Parkinson's Disease (PD), run by Palacky University at 1 site in Czechia.
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 5 inclusion and 3 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 13 Oct 2026. 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 Czechia. 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 Zuzana Turiaková, Mgr. (MSc.) (+420724331263, zuzana.turiakova01@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Sufficiency Test Score (time frame: 3 weeks). The study lists 6 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 13 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.