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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
FOGQ
Time Frame: One month
Freezing of Gait Questionnaire Value
One month

Secondary Outcome Measures

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

Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

  • 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

March 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (ESTIMATE)

March 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Parkinson Disease

Clinical Trials on MIRT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe