MicrokinesitherapyNCT05494879
Effectiveness of Microkinesitherapy in Seniors
A study testing microkinesitherapy treatment in people with Microkinesitherapy, run by The Opole University of Technology at 1 site in Poland.
Trial summary
Many specialists stress that the aging process is individual, its course, severity and occurrence of disease are not the same for all seniors. The studies indicate that SA should be conceptualized as a process, using developmental trajectories of functioning as component parts, and can take several forms. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Microkinesitherapy
- What is being tested?
- microkinesitherapy treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePoland
- Study dates
- 17 Aug 2022to 18 Jul 2023
- 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- informed consent to participate in the study
Who cannot join
- pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms
- less than 6 months after a heart attack, state after thoracic and cardiac surgery
- uncontrolled hypertension
- insulin-dependent diabetes
- lung cancer
- cognitive impairment or Mini-Mental State Examination < 24.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Faculty of Physical Education and Physiotherapy, Opole University of Technology
Opole, 45-758
About this study
Official title: Evaluation of the Effect of Microkinesitherapy Treatment on Psychosomatic Functions in Community-dwelling Older Adults: A Pilot Study
Many specialists stress that the aging process is individual, its course, severity and occurrence of disease are not the same for all seniors. The studies indicate that SA should be conceptualized as a process, using developmental trajectories of functioning as component parts, and can take several forms. The nature of "successful" trajectories varied from a limited decline over time (e.g., cognitive and physical functioning), stability over time (e.g., self-perceived health) to recovery (from social loneliness) and growth (in life satisfaction and emotional support provided). Therefore, the aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults.
Read the detailed description
new therapeutic methods are being proposed that can be used in the community to steer the aging process toward "healthy aging." An example of a holistic approach to the patient can be found in microkinesitherapy. The focus of microkinesitherapy is to find and restore areas of the body that have lost their vitality and mobility, using gentle touches on various body tissues using specific body maps. The aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults. It was decided to evaluate the impact of a single therapy session on a range of psycho-somatic indicators. The hypotheses were as follows: (H1) The microkinesitherapy intervention will improve the physical function assessed using the Senior Fitness Test, (H2) A single microkinesitherapy treatment will not affect gait performance, (H3) A single microkinesitherapy treatment will improve the quality of life of the participants.
- Conditions
- Microkinesitherapy
- Being tested
- microkinesitherapy treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microkinesitherapy treatmentBehavioural
The therapeutic session of microkinesitherapy included a seeking of "body scares" both taking into account somatic dysfunctions as well as psychosomatic disorders. According to the creators of the method, Grosjean and Benini "Everything that happens with us in a toxic level, either physically or emotionally, are stored by the brain which keeps memories and generates links that may harm the function of the cells generating a vast array of symptoms and dysfunctions".
| Study group | Role | What they receive |
|---|---|---|
| microkinesitherapy treatment | Experimental | The study group received a single therapy session of microkinesitherapy. The entire procedure lasted about 10 minutes. Microkinesitherapy is based on locating information in the patient's body about previous traumas/traumas that have been experienced physically and emotionally, which the body could not eliminate. This information is interpreted on the body by sensitive tensions and called "body scars" and does not necessarily remain in the brain. Receives: Behavioral: microkinesitherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Senior Fitness Test
The Senior Fitness Test (also known as the Fullerton test) was used to assess physical fitness. Five motor tasks were evaluated, including strength, endurance, flexibility, agility, balance, and motor coordination. The sixth component of the test: the 6-minute walk test could not be performed due to the patients' low functional status.
Measured: baseline, 1-month follow-up
Change of the gait parameters
Gait cycle analysis was performed with the subject barefoot over a distance of 5 m long and 2 m wide, making 2 passes (10 m) at normal gait speed. For gait analysis, a wireless inertial sensor system BTS G-WALK (BTS Bioengineering S.p.A., Milan, Italy) was used, placed by means of a semi-elastic belt at the level of the fifth lumbar vertebra (L5) and the first two sacral vertebrae (S1-S2).
Measured: baseline, 1-month follow-up
Change of the quality of life
The WHO's questions stem from multiple statements about quality of life, health and well-being from people with and without disease, and health professionals. The questionnaire was validated and identifies four major domains: Physical health, Psychological, Social relationships, Environment. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed to a 0-100 or 4-20 scales. Lower score indicates poorer quality of life
Measured: baseline, 1-month follow-up
Change of the mental health
The GHQ-12 General Health Questionnaire enables the identification of people whose mental state has broken down temporarily or over the long term as a result of difficulties experienced, problems or as a result of mental illness, and those who are at significant risk of mental health disorders. A version of the GHQ-28 provides an overall score that is an indicator of the patient's mental health, divided into 4 scales: somatic symptoms; anxiety, insomnia; dysfunction and symptoms of depression. The scoring type used in this study was Likert scoring methods (0-1-2-3). Higher score indicates greater disorder
Measured: baseline, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start17 Aug 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion18 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrokinesitherapyStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494879
- Sponsor's protocol ID
- Micro_Poznan
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data presented in this study are available upon request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Microkinesitherapy Treatment on Psychosomatic Functions in Community-dwelling Older Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT05494879
- Acronym / sponsor ID
- Micro_Poznan
- Conditions
- Microkinesitherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 17 Aug 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 18 Jul 2023 (estimated)
- First posted
- 10 Aug 2022 (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.
Many specialists stress that the aging process is individual, its course, severity and occurrence of disease are not the same for all seniors. The studies indicate that SA should be conceptualized as a process, using developmental trajectories of functioning as component parts, and can take several forms. The nature of "successful" trajectories varied from a limited decline over time (e.g., cognitive and physical functioning), stability over time (e.g., self-perceived health) to recovery (from social loneliness) and growth (in life satisfaction and emotional support provided). Therefore, the aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults.
Detailed description
new therapeutic methods are being proposed that can be used in the community to steer the aging process toward "healthy aging." An example of a holistic approach to the patient can be found in microkinesitherapy. The focus of microkinesitherapy is to find and restore areas of the body that have lost their vitality and mobility, using gentle touches on various body tissues using specific body maps. The aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults. It was decided to evaluate the impact of a single therapy session on a range of psycho-somatic indicators. The hypotheses were as follows: (H1) The microkinesitherapy intervention will improve the physical function assessed using the Senior Fitness Test, (H2) A single microkinesitherapy treatment will not affect gait performance, (H3) A single microkinesitherapy treatment will improve the quality of life of the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microkinesitherapy treatment | Experimental | Behavioral: microkinesitherapy treatmentThe study group received a single therapy session of microkinesitherapy. The entire procedure lasted about 10 minutes. Microkinesitherapy is based on locating information in the patient's body about previous traumas/traumas that have been experienced physically and emotionally, which the body could not eliminate. This information is interpreted on the body by sensitive tensions and called "body scars" and does not necessarily remain in the brain. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- informed consent to participate in the study
Key exclusion criteria (6 listed)
- pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms
- less than 6 months after a heart attack, state after thoracic and cardiac surgery
- uncontrolled hypertension
- insulin-dependent diabetes
- lung cancer
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 |
|---|---|---|
| microkinesitherapy treatmentThe therapeutic session of microkinesitherapy included a seeking of "body scares" both taking into account somatic dysfunctions as well as psychosomatic disorders. According to the creators of the method, Grosjean and Benini "Everything that happens with us in a toxic level, either physically or emotionally, are stored by the brain which keeps memories and generates links that may harm the function of the cells generating a vast array of symptoms and dysfunctions". | Behavioural | microkinesitherapy treatment |
Primary outcome
Change of the Senior Fitness Test
Time frame: baseline, 1-month follow-up
The Senior Fitness Test (also known as the Fullerton test) was used to assess physical fitness. Five motor tasks were evaluated, including strength, endurance, flexibility, agility, balance, and motor coordination. The sixth component of the test: the 6-minute walk test could not be performed due to the patients' low functional status.
Change of the gait parameters
Time frame: baseline, 1-month follow-up
Gait cycle analysis was performed with the subject barefoot over a distance of 5 m long and 2 m wide, making 2 passes (10 m) at normal gait speed. For gait analysis, a wireless inertial sensor system BTS G-WALK (BTS Bioengineering S.p.A., Milan, Italy) was used, placed by means of a semi-elastic belt at the level of the fifth lumbar vertebra (L5) and the first two sacral vertebrae (S1-S2).
Change of the quality of life
Time frame: baseline, 1-month follow-up
The WHO's questions stem from multiple statements about quality of life, health and well-being from people with and without disease, and health professionals. The questionnaire was validated and identifies four major domains: Physical health, Psychological, Social relationships, Environment. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed to a 0-100 or 4-20 scales. Lower score indicates poorer quality of life
Change of the mental health
Time frame: baseline, 1-month follow-up
The GHQ-12 General Health Questionnaire enables the identification of people whose mental state has broken down temporarily or over the long term as a result of difficulties experienced, problems or as a result of mental illness, and those who are at significant risk of mental health disorders. A version of the GHQ-28 provides an overall score that is an indicator of the patient's mental health, divided into 4 scales: somatic symptoms; anxiety, insomnia; dysfunction and symptoms of depression. The scoring type used in this study was Likert scoring methods (0-1-2-3). Higher score indicates greater disorder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Yes. The data presented in this study are available upon request from the corresponding author.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microkinesitherapy treatment in people with Microkinesitherapy, run by The Opole University of Technology at 1 site in Poland.
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 1 inclusion and 6 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 10 Aug 2022. 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 Poland. 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?
Results are not available in the source record.
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?
Change of the Senior Fitness Test (time frame: baseline, 1-month follow-up). The study lists 4 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 10 Aug 2022.