Hallux Mobilization in Patients With Parkinson's Disease (HalluxPD001)

March 24, 2014 updated by: Ospedale Generale Di Zona Moriggia-Pelascini

Passive Mobilization of the Metatarsophalangeal Joint of the Hallux During a Rehabilitation Treatment in Patients With Parkinson's Disease

Parkinson's disease is a degenerative disorder of the central nervous system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in the course of the disease, the most obvious symptoms are movement-related; these include shaking, rigidity, slowness of movement and difficulty with walking and gait. A multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different parameters in PD that are poorly responsive to dopaminergic therapy. In this study, we aim to understand whether the passive mobilization of the metatarsophalangeal joint of the hallux determines an increase in the joint range in this district, allowing to improve, at least, the gait.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Parkinson's disease is a degenerative disorder of the central nervous system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in the course of the disease, the most obvious symptoms are movement-related; these include shaking, rigidity, slowness of movement and difficulty with walking and gait. The main families of drugs useful for treating motor symptoms are levodopa dopamine agonists and Monoamine oxidases-B inhibitors.A multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different parameters in PD that are poorly responsive to the pharmacological therapy. In this study, we aim to understand whether the passive mobilization of the metatarsophalangeal joint of the hallux determines an increase in the joint range in this district, allowing to improve, at least, the gait in patients with PD. In this course, we will evaluate whether passive mobilization of this joint, lead to positive effects on the freezing of gait and on the festination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Como
      • Gravedona, Como, Italy, 22015
        • Parkinson's Disease and Movement Disorders Rehabilitation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

49 years to 88 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PD

Description

Inclusion Criteria:

PD patients stage 3 H&Y with FOG

Exclusion Criteria:

we excluded patients with atypical parkinsonism, with other concomitant neurological conditions (with cerebrovascular etc.), with joint disorders, muscle disorders or with other orthopedic conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with passive joint mobilization
Patients diagnosed with PD according to the Gelb et al in Hoen&Yahr stage 3, with Freezing of Gait and treated with a Multidisciplinary intensive rehabilitation treatment (MIRT), including the mobilization of the metatarsophalangeal joint of the hallux
Other: MIRT
A 4-week cycle of physiotherapy that entailed three daily sessions, 5 days a week. The first session comprised cardiovascular warm-up activities, relaxation exercises, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, and exercises to improve the functionality of abdominal muscles and postural changes in the supine position. The second session included exercises to improve balance and gait using a stabilometric platform with a visual cue and treadmill training associated with auditory and visual cues (treadmill plus). The last was an occupational therapy session with the aim of improving autonomy in daily living activities.
Other: Mobilization of the metatarsophalangeal joint of the hallux
MIRT and mobilization of the metatarsophalangeal joint of the hallux
No passive joint mobilization
Patients diagnosed with PD according to the Gelb et al in Hoen&Yahr stage 3, with Freezing of Gait and treated with a Multidisciplinary intensive rehabilitation treatment (MIRT)
Other: MIRT
A 4-week cycle of physiotherapy that entailed three daily sessions, 5 days a week. The first session comprised cardiovascular warm-up activities, relaxation exercises, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, and exercises to improve the functionality of abdominal muscles and postural changes in the supine position. The second session included exercises to improve balance and gait using a stabilometric platform with a visual cue and treadmill training associated with auditory and visual cues (treadmill plus). The last was an occupational therapy session with the aim of improving autonomy in daily living activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FOGQ
Time Frame: One month
Freezing of Gait Questionnaire Value
One month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BBS
Time Frame: One month
Berg Balance Scale
One month
UPDRS III
Time Frame: One month
Unified Parkinson's disease Rating Scale
One month
Hallux
Time Frame: One month
Range of metatarsophalangeal joint value
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giuseppe Frazzitta, MD, Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HalluxPD001
  • Hallux PD 001 (OTHER: Ospedale Generale di Zona "Moriggia-Pelascini")

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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