Parkinson DiseaseHalluxPD001NCT02098642
Hallux Mobilization in Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 49 to 88 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- MIRT and Mobilization of the metatarsophalangeal joint of the hallux
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD
Who may be able to join
- PD patients stage 3 H\&Y with FOG
Who cannot join
- we excluded patients with atypical parkinsonism, with other concomitant neurological conditions (with cerebrovascular etc.), with joint disorders, muscle disorders or with other orthopedic conditions.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Parkinson's Disease and Movement Disorders Rehabilitation Unit
Gravedona, Como, 22015
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- MIRT, Mobilization of the metatarsophalangeal joint of the hallux
- Keywords
- Gait Disturbances, Metatarsophalangeal joint
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRTOther
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.
Mobilization of the metatarsophalangeal joint of the halluxOther
MIRT and mobilization of the metatarsophalangeal joint of the hallux
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MIRT; Other: 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) Receives: Other: MIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
FOGQ
Freezing of Gait Questionnaire Value
Measured: One month
Secondary outcomes (3)
UPDRS III
Unified Parkinson's disease Rating Scale
Measured: One month
BBS
Berg Balance Scale
Measured: One month
Hallux
Range of metatarsophalangeal joint value
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098642
- Sponsor's protocol ID
- HalluxPD001
- Other IDs
- Hallux PD 001
- Acronym
- HalluxPD001
- Status last verified
- Mar 2014
- First submitted
- 21 Mar 2014
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Mobilization of the Metatarsophalangeal Joint of the Hallux During a Rehabilitation Treatment in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02098642
- Acronym / sponsor ID
- HalluxPD001 / HalluxPD001
- Conditions
- Parkinson Disease
- Keywords
- Gait Disturbances, Metatarsophalangeal joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with passive joint mobilization | – | Other: MIRT, Other: Mobilization of the metatarsophalangeal joint of the halluxPatients 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 |
| No passive joint mobilization | – | Other: MIRTPatients 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) |
Who may qualify
- Ages
- 49 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD
Key inclusion criteria (1 listed)
- PD patients stage 3 H\&Y with FOG
Key exclusion criteria (1 listed)
- we excluded patients with atypical parkinsonism, with other concomitant neurological conditions (with cerebrovascular etc.), with joint disorders, muscle disorders or with other orthopedic conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIRTA 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 | No passive joint mobilization, Patients with passive joint mobilization |
| Mobilization of the metatarsophalangeal joint of the halluxMIRT and mobilization of the metatarsophalangeal joint of the hallux | Other | Patients with passive joint mobilization |
Primary outcome
FOGQ
Time frame: One month
Freezing of Gait Questionnaire Value
3 secondary outcomes
UPDRS III
Time frame: One month
BBS
Time frame: One month
Hallux
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Frazzitta, MD principal investigator
Ospedale Generale Di Zona Moriggia-Pelascini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FOGQ (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.