Parkinson Disease and Pisa SyndromeNCT04137848
Effects of Osteopathic Manipulative Treatment on Postural Control in Parkinson's Disease/Pisa Syndrome Patients
A study testing Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) in people with Parkinson Disease and Pisa Syndrome, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the efficacy of osteopathic manipulations added to an intensive, multidisciplinary rehabilitative (MIRT) program on postural control of PD-PS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease and Pisa Syndrome
- What is being tested?
- Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pisa Syndrome and Parkinson Disease
- PS Onset \< 12 months
- TLF \> 10 degrees
Who cannot join
- Scoliosis or spine deformity
- Changes of PD pharmacological therapy within 3 months
- Co-morbidity with other neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: a Pilot Randomized Placebo-controlled Trial
The aim of the study is to evaluate the efficacy of osteopathic manipulations added to an intensive, multidisciplinary rehabilitative (MIRT) program on postural control of PD-PS patients.
Read the detailed description
Pisa Syndrome is frequently associated with Parkinson Disease and it is characterized by a trunk lateral flexion higher than 10 degrees that is reversible with the lying position. Its pathophysiology is multifactorial, and it is probably different depending on disease onset duration. However, a relevant association between subjective visual vertical misperception and the PS involved side was recently described. Moreover, an impairment in postural control in PD-PS patients has been recognized. Nowadays, physical therapy is the standard treatment and it is proposed to ameliorate paraspinal muscle hyperactivity and balance, as showed by previews descriptive and clinical studies. Despite being physical therapy a cornerstone in PD-PS axial symptoms treatment, the therapeutic protocol for postural control in PD-PS patients is under active study.
In recent years, preliminary studies described the effects of osteopathic manipulative treatment on motor functionality and balance in PD patients in a multidisciplinary setting, which is in line with the evidence of the need of a multidisciplinary and intensive approach to achieve better outcomes. However, the effect of OMT has never been investigated in PD-PS patients. The aim of the study is to evaluate the effects of OMT on postural control of PD-PS patients undergoing the MIRT program. Literature reported the possible benefit of OMT on the balance of healthy subjects, possibly interacting with the multisensorial integration of balance. 24 PD-PS patients are enrolled and randomized in two groups. Posturography is performed to assess Eye-closed Sway Area (ECSA) at baseline and 30 days after enrolment. The investigator who perform posturography and trunk inclination assessment is kept blinded. Trunk inclination is measured with "DIERS Formetric 4D". Other variables considered in the investigation are Eye-opened sway area (EOSA), Trunk Lateral Flexion (TLF), Kyphothic Angle (KA), Unified Parkinson Disease Rating Scale (UPDRS), Six-minute Walking Test (6MWT).
- Conditions
- Parkinson Disease and Pisa Syndrome
- Being tested
- Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT), Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)Procedure or surgery
OMT: 4-week manual therapeutic program with a weekly session of osteopathic examination and manipulation of somatic disfunctions in ambulatory setting. MIRT: 4-week physical therapy with 4 daily sessions (1 hour each), 5days/week, in a hospital setting. The first session comprises cardiovascular warm-up activities, relaxation, muscle stretching, exercises to improve the range of motion of different joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes exercises to improve balance and gait using stabilometric platform,treadmill plus, crossover and cycloergometer. The third and fourth pertain occupational and speech therapy.
Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)Procedure or surgery
SOMT: 4-week of sham osteopathic therapeutic program with a weekly session of osteopathic examination and manipulation in ambulatory setting.
MIRT: 4-week physical therapy with 4 daily sessions (1 hour each), 5days/week, in a hospital setting. The first session comprises cardiovascular warm-up activities, relaxation, muscle stretching, exercises to improve the range of motion of different joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes exercises to improve balance and gait using stabilometric platform,treadmill plus, crossover and cycloergometer. The third and fourth pertain occupational and speech therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) Osteopathic Manipulative Treatment (OMT) is manipulative therapy that was performed once a week along 30 days. Receives: Procedure: Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) |
| Control | Sham comparator | Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) Osteopathic Manipulative Treatment (OMT) is manipulative therapy that was performed once a week along 30 days. Receives: Procedure: Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye-closed sway area (ECSA)
ECSA is assessed with posturography and represents the transformation of the area described by a subject's centre of pressure in eye closed standing. It is used to assess postural stability.
Measured: 1 month
Secondary outcomes (4)
Trunk Lateral Flexion (TLF)
Area described by subject's centre of posture
Measured: 1 month
Kyphothic Angle (KA)
Biomechanical parameter to assess subject's trunk lateral tilt.
Measured: 1 month
Unified Parkinson Disease Rating Scale (UPDRS)
Clinical scale for Parkinson Disease (min 0 points; max 199 points) where the higher scores describes worse outcomes.
Measured: 1 month
Six-minute Walking Test (6MWT)
Functional parameter to assess physical activity reservoir of the subjects.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study startJan 2015
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease and Pisa SyndromeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137848
- Sponsor's protocol ID
- Osteopathy2019
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: a Pilot Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04137848
- Acronym / sponsor ID
- Osteopathy2019
- Conditions
- Parkinson Disease and Pisa Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Oct 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 the study is to evaluate the efficacy of osteopathic manipulations added to an intensive, multidisciplinary rehabilitative (MIRT) program on postural control of PD-PS patients.
Detailed description
Pisa Syndrome is frequently associated with Parkinson Disease and it is characterized by a trunk lateral flexion higher than 10 degrees that is reversible with the lying position. Its pathophysiology is multifactorial, and it is probably different depending on disease onset duration. However, a relevant association between subjective visual vertical misperception and the PS involved side was recently described. Moreover, an impairment in postural control in PD-PS patients has been recognized. Nowadays, physical therapy is the standard treatment and it is proposed to ameliorate paraspinal muscle hyperactivity and balance, as showed by previews descriptive and clinical studies. Despite being physical therapy a cornerstone in PD-PS axial symptoms treatment, the therapeutic protocol for postural control in PD-PS patients is under active study.
In recent years, preliminary studies described the effects of osteopathic manipulative treatment on motor functionality and balance in PD patients in a multidisciplinary setting, which is in line with the evidence of the need of a multidisciplinary and intensive approach to achieve better outcomes. However, the effect of OMT has never been investigated in PD-PS patients. The aim of the study is to evaluate the effects of OMT on postural control of PD-PS patients undergoing the MIRT program. Literature reported the possible benefit of OMT on the balance of healthy subjects, possibly interacting with the multisensorial integration of balance. 24 PD-PS patients are enrolled and randomized in two groups. Posturography is performed to assess Eye-closed Sway Area (ECSA) at baseline and 30 days after enrolment. The investigator who perform posturography and trunk inclination assessment is kept blinded. Trunk inclination is measured with "DIERS Formetric 4D". Other variables considered in the investigation are Eye-opened sway area (EOSA), Trunk Lateral Flexion (TLF), Kyphothic Angle (KA), Unified Parkinson Disease Rating Scale (UPDRS), Six-minute Walking Test (6MWT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) Osteopathic Manipulative Treatment (OMT) is manipulative therapy that was performed once a week along 30 days. |
| Control | Sham comparator | Procedure: Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) Osteopathic Manipulative Treatment (OMT) is manipulative therapy that was performed once a week along 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pisa Syndrome and Parkinson Disease
- PS Onset \< 12 months
- TLF \> 10 degrees
Key exclusion criteria (3 listed)
- Scoliosis or spine deformity
- Changes of PD pharmacological therapy within 3 months
- Co-morbidity with other neurological disease
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 |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)OMT: 4-week manual therapeutic program with a weekly session of osteopathic examination and manipulation of somatic disfunctions in ambulatory setting. MIRT: 4-week physical therapy with 4 daily sessions (1 hour each), 5days/week, in a hospital setting. The first session comprises cardiovascular warm-up activities, relaxation, muscle stretching, exercises to improve the range of motion of different joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes exercises to improve balance and gait using stabilometric platform,treadmill plus, crossover and cycloergometer. The third and fourth pertain occupational and speech therapy. | Procedure or surgery | Experimental |
| Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)SOMT: 4-week of sham osteopathic therapeutic program with a weekly session of osteopathic examination and manipulation in ambulatory setting. MIRT: 4-week physical therapy with 4 daily sessions (1 hour each), 5days/week, in a hospital setting. The first session comprises cardiovascular warm-up activities, relaxation, muscle stretching, exercises to improve the range of motion of different joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes exercises to improve balance and gait using stabilometric platform,treadmill plus, crossover and cycloergometer. The third and fourth pertain occupational and speech therapy. | Procedure or surgery | Control |
Primary outcome
Eye-closed sway area (ECSA)
Time frame: 1 month
ECSA is assessed with posturography and represents the transformation of the area described by a subject's centre of pressure in eye closed standing. It is used to assess postural stability.
4 secondary outcomes
Trunk Lateral Flexion (TLF)
Time frame: 1 month
Kyphothic Angle (KA)
Time frame: 1 month
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: 1 month
Six-minute Walking Test (6MWT)
Time frame: 1 month
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 18 Jan 2020.
Related trials for Parkinson Disease and Pisa Syndrome
Recruiting
Integrating AI in Postural Rehabilitation for Parkinson's Disease
Parkinson Disease, Physical Inactivity
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 Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) in people with Parkinson Disease and Pisa Syndrome, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 18 Jan 2020. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Eye-closed sway area (ECSA) (time frame: 1 month). 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 18 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.