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Effects of Osteopathic Manipulative Treatment on Postural Control in Parkinson's Disease/Pisa Syndrome Patients

Primary Purpose

Parkinson Disease and Pisa Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease and Pisa Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pisa Syndrome and Parkinson Disease
  • PS Onset < 12 months
  • TLF > 10 degrees

Exclusion Criteria:

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

Sites / Locations

  • Ospedale Generale di Zona Moriggia Pelascini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Trunk Lateral Flexion (TLF)
Area described by subject's centre of posture
Kyphothic Angle (KA)
Biomechanical parameter to assess subject's trunk lateral tilt.
Unified Parkinson Disease Rating Scale (UPDRS)
Clinical scale for Parkinson Disease (min 0 points; max 199 points) where the higher scores describes worse outcomes.
Six-minute Walking Test (6MWT)
Functional parameter to assess physical activity reservoir of the subjects.

Full Information

First Posted
October 22, 2019
Last Updated
January 15, 2020
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT04137848
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease and Pisa Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eye-closed sway area (ECSA)
Description
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
Secondary Outcome Measure Information:
Title
Trunk Lateral Flexion (TLF)
Description
Area described by subject's centre of posture
Time Frame
1 month
Title
Kyphothic Angle (KA)
Description
Biomechanical parameter to assess subject's trunk lateral tilt.
Time Frame
1 month
Title
Unified Parkinson Disease Rating Scale (UPDRS)
Description
Clinical scale for Parkinson Disease (min 0 points; max 199 points) where the higher scores describes worse outcomes.
Time Frame
1 month
Title
Six-minute Walking Test (6MWT)
Description
Functional parameter to assess physical activity reservoir of the subjects.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pisa Syndrome and Parkinson Disease PS Onset < 12 months TLF > 10 degrees Exclusion Criteria: Scoliosis or spine deformity Changes of PD pharmacological therapy within 3 months Co-morbidity with other neurological disease
Facility Information:
Facility Name
Ospedale Generale di Zona Moriggia Pelascini
City
Gravedona
State/Province
CO
ZIP/Postal Code
22015
Country
Italy

12. IPD Sharing Statement

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Effects of Osteopathic Manipulative Treatment on Postural Control in Parkinson's Disease/Pisa Syndrome Patients

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