An interventional study of Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) and Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT) in Parkinson Disease and Pisa Syndrome, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Not applicable, Interventional, and Treatment
Among 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini — none open to participants now, none under way, none of them phase 3. Parkinson Disease · Ospedale Generale Di Zona Moriggia-Pelascini.
Among the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini, this one is the 13th largest by enrollment of the 13 interventional ones that give a count, is one of 6 that started in 2015, is one of 13 with no phase, and was the 21st registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
Browse Parkinson Disease studies →None of the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini is open now. The open studies under Parkinson Disease, anywhere →
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 6 started in 2015.
This study's enrollment of 24 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Median enrollment 100 across the 13 interventional studies, 80 across the 10 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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Ospedale Generale Di Zona Moriggia-Pelascini is the lead sponsor of 36 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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).
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Exclusion Criteria:
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.
Procedure: Osteopathic Manipulative Treatment (OMT)+ 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.
Procedure: Sham Osteopathic Manipulative Treatment (SOMT)+ 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.
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.
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.
Time frame: 1 month
Trunk Lateral Flexion (TLF)
Area described by subject's centre of posture
Time frame: 1 month
Kyphothic Angle (KA)
Biomechanical parameter to assess subject's trunk lateral tilt.
Time frame: 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.
Time frame: 1 month
Six-minute Walking Test (6MWT)
Functional parameter to assess physical activity reservoir of the subjects.
Time frame: 1 month
Ran from Jan 2015 to primary completion in Sep 2016, 20 months.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 20 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Ospedale Generale Di Zona Moriggia-Pelascini