Parkinson DiseaseH_F_ D_PD_MIRTNCT03763955
Effectiveness of MIRT on Hand and Finger Dexterity in PD Patients
An observational study of Parkinson Disease and Dexterity, run by Ospedale Generale Di Zona Moriggia-Pelascini.
Trial summary
Aims of the study are (1) to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and (2) its impact on daily living autonomy of PD patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Dexterity, Rehabilitation
- What is being tested?
- MIRT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 482 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Aug 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parkinsonian inpatients
Who may be able to join
- diagnosis of Parkinson's Disease
Who cannot join
- other neurological disease
- psychosis
- auditive or visual deficit
About this study
Aims of the study are (1) to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and (2) its impact on daily living autonomy of PD patients.
Read the detailed description
Reduction in hand functionality and finger dexterity are significant, but often overlooked, symptoms of Parkinson's Disease (PD). They are strictly correlated with loss of patient's autonomy, due to their significant impact on Activities of Daily Living (ADL) and, consequently in patient's Quality of life (QoL). No studies investigated the effectiveness of a specific and functional-based Occupational Therapy (OT) treatment in improving hand functionality and finger dexterity in PD patients.
Aims of tthe study are to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and its impact on daily living autonomy of PD patients.
Retrospectively, 482 PD patients, hospitalized for a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT) between January 2015 and January 2018 were identified. All patients underwent 1h/day OT treatment. The outcome measure was the O'Connor finger dexterity test; secondary outcome measures were Minnesota dexterity test, UPDRS II and SPDDS scale. These measures were assessed at admission (T0) and discharge (T1).
- Conditions
- Parkinson Disease, Dexterity, Rehabilitation
- Being tested
- MIRT
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRTBehavioural
Also called Multidisciplinary Intensive Rehabilitation Treatment
4 week MIRT provide:
- front to front treatment (1 hour/day for 5 days/week)
- treatment with robotic devices (1 hour/day for 5 days/week)
- occupational therapy (1 hour/day for 5 days/week)
| Study group | Role | What they receive |
|---|---|---|
| PD patients | PD patients at 1-5 H\&Y stage undergoes 4week Multidisciplinary Intensive Rehabilitation Treatment Receives: Behavioral: MIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
O'Connor Finger Dexterity Test
peg-placement test aimed to evaluate the ability to manipulate small objects
Measured: 4 weeks
Secondary outcomes (1)
Minnesota Manual Dexterity Test
test aimed to evaluate the reach-to-grasp movements, gros manual dexterity and left vs right manual impairment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Jan 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
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
- Cohort
- Time perspective
- Other
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763955
- Sponsor's protocol ID
- H_F_D_PD_MIRT
- Acronym
- H_F_ D_PD_MIRT
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of MIRT on Hand and Finger Dexterity in PD Patients
- ClinicalTrials.gov ID
- NCT03763955
- Acronym / sponsor ID
- H_F_ D_PD_MIRT / H_F_D_PD_MIRT
- Conditions
- Parkinson Disease, Dexterity, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 4 Dec 2018 (actual)
- 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.
Aims of the study are (1) to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and (2) its impact on daily living autonomy of PD patients.
Detailed description
Reduction in hand functionality and finger dexterity are significant, but often overlooked, symptoms of Parkinson's Disease (PD). They are strictly correlated with loss of patient's autonomy, due to their significant impact on Activities of Daily Living (ADL) and, consequently in patient's Quality of life (QoL). No studies investigated the effectiveness of a specific and functional-based Occupational Therapy (OT) treatment in improving hand functionality and finger dexterity in PD patients.
Aims of tthe study are to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and its impact on daily living autonomy of PD patients.
Retrospectively, 482 PD patients, hospitalized for a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT) between January 2015 and January 2018 were identified. All patients underwent 1h/day OT treatment. The outcome measure was the O'Connor finger dexterity test; secondary outcome measures were Minnesota dexterity test, UPDRS II and SPDDS scale. These measures were assessed at admission (T0) and discharge (T1).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | Behavioral: MIRTPD patients at 1-5 H\&Y stage undergoes 4week Multidisciplinary Intensive Rehabilitation Treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parkinsonian inpatients
Key inclusion criteria (1 listed)
- diagnosis of Parkinson's Disease
Key exclusion criteria (3 listed)
- other neurological disease
- psychosis
- auditive or visual deficit
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 |
|---|---|---|
| MIRTAlso: Multidisciplinary Intensive Rehabilitation Treatment4 week MIRT provide: 1. front to front treatment (1 hour/day for 5 days/week) 2. treatment with robotic devices (1 hour/day for 5 days/week) 3. occupational therapy (1 hour/day for 5 days/week) | Behavioural | PD patients |
Primary outcome
O'Connor Finger Dexterity Test
Time frame: 4 weeks
peg-placement test aimed to evaluate the ability to manipulate small objects
1 secondary outcome
Minnesota Manual Dexterity Test
Time frame: 4 weeks
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 4 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dexterity, run by Ospedale Generale Di Zona Moriggia-Pelascini.
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 3 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
O'Connor Finger Dexterity Test (time frame: 4 weeks). 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 4 Dec 2018.