NCT04137848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

October 22, 2019

Last Update Submit

January 15, 2020

Conditions

Parkinson Disease and Pisa Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (4)

  • Trunk Lateral Flexion (TLF)

    1 month

  • Kyphothic Angle (KA)

    1 month

  • Unified Parkinson Disease Rating Scale (UPDRS)

    1 month

  • Six-minute Walking Test (6MWT)

    1 month

Study Arms (2)

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.

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.

Procedure: Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)

Interventions

Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)PROCEDURE

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.

Experimental
Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)PROCEDURE

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Generale di Zona Moriggia Pelascini

Gravedona, CO, 22015, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

IT(1)