Clinical trial NCT04137848: Effects of Osteopathic Manipulative Treatment on Postural Control in Parkinson's Disease/Pisa Syndrome Patients
Official title: Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: a Pilot Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease and Pisa Syndrome
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* Pisa Syndrome and Parkinson Disease
* PS Onset \&lt; 12 months
* TLF \&gt; 10 degrees

Exclusion Criteria:

* Scoliosis or spine deformity
* Changes of PD pharmacological therapy within 3 months
* Co-morbidity with other neurological disease

Primary outcomes:
measure: Eye-closed sway area (ECSA)
timeFrame: 1 month
Secondary outcomes:
measure: Trunk Lateral Flexion (TLF)
timeFrame: 1 month
measure: Kyphothic Angle (KA)
timeFrame: 1 month
measure: Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: 1 month
measure: Six-minute Walking Test (6MWT)
timeFrame: 1 month
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Ospedale Generale di Zona Moriggia Pelascini
state: CO
Study officials:
References: