Parkinson's DiseaseNCT02051556
Working on Asymmetry in Parkinson's Disease
A study testing Physical Therapy WSI, Physical Therapy BSI and Physical Therapy ST in people with Parkinson's Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and progression. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Physical Therapy WSI, Physical Therapy BSI and Physical Therapy ST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Sep 2014
- Phase
- Interventional
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease, freezing of gait history, informed consent
Who cannot join
- depression, severe orthopedic diseases
Trial locations and contacts
1 site in 1 country.
Nicola Modugno, MD, PhD contact
About this study
Official title: Working on Asymmetry in Parkinson's Disease: a Double Blind, Randomized, Controlled Rehabilitation Trial.
Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and progression.
In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been reported to be associated with FOG episodes. As the maintenance of gait depends on the precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral coordination may impair gait sequence, potentially causing freezing.
Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait. Aim of the study was to evaluate how the modulation of asymmetry through physical therapy might improve gait and FOG.
Read the detailed description
The patients will be'blind' to the study protocol and will be randomly assigned to one of the three study arms: 1) physiotherapy aimed to potentiate the more affected body side (worst side improvement, WSI); 2) physiotherapy aimed to potentiate the less affected body side (best side improvement, BSI); 3) physiotherapy aimed to potentiate both sides equally (standard treatment, ST). Each group will be undergo physiotherapy twice a week for three months. Each session will have duration of one hour and include a first part of warming up, a final part of cooling down (these two parts are the same for all the groups) and an active part (which is different from group to group). The active part includes exercises which are alike for all the groups but with a number of repetitions different from group to group according to the aim of potentiating the most affected side (WSI) or the least affected side (BSI) or both sides equally (in this case the number of repetitions was the same for both sides; ST). Medical treatment will be kept stable through all the study duration; medications are expressed as levodopa daily dose equivalent (LEDD).
- Conditions
- Parkinson's Disease
- Being tested
- Physical Therapy WSI, Physical Therapy BSI, Physical Therapy ST
- Keywords
- Parkinson's disease, Freezing of gait, Asymmetry, Rehabilitation, Physical therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy WSIBehavioural
Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the most affected side (WSI).
Physical Therapy BSIBehavioural
Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the least affected side (BSI).
Physical Therapy STBehavioural
Each session has duration of one hour and includes a first part of warming up, a final part of cooling down and an active part that includes exercises with a number of repetitions according to the aim of potentiating both sides equally (ST). In this case the number of repetitions was the same for both sides.
| Study group | Role | What they receive |
|---|---|---|
| Best Side Improvement | Experimental | Physical Therapy BSI (Best Side Improvement), aimed to potentiate the less affected body side. Receives: Behavioral: Physical Therapy BSI |
| Worse side improvement | Experimental | Physical Therapy WSI (Worst Side Improvement), aimed to potentiate the most affected body side. Receives: Behavioral: Physical Therapy WSI |
| Standard treatment | Active comparator | Physical Therapy ST (Standard Treatment), aimed to potentiate both sides equally. Receives: Behavioral: Physical Therapy ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Symptoms
Measured: 24 weeks
Secondary outcomes (1)
Freezing of gait
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Modugno, Neuromed IRCCS
- Investigators
- Nicola Modugno, MD, PhD, Study chair, IRCCS NEUROMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051556
- Sponsor's protocol ID
- ASPD-01
- Status last verified
- Feb 2014
- First submitted
- 16 Jan 2014
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Modugno N, Iaconelli S, Fiorlli M, Lena F, Kusch I, Mirabella G. Active theater as a complementary therapy for Parkinson's disease rehabilitation: a pilot study. ScientificWorldJournal. 2010 Nov 16;10:2301-13. doi: 10.1100/tsw.2010.221.
PubMed 21103799
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working on Asymmetry in Parkinson's Disease: a Double Blind, Randomized, Controlled Rehabilitation Trial.
- ClinicalTrials.gov ID
- NCT02051556
- Acronym / sponsor ID
- ASPD-01
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Freezing of gait, Asymmetry, Rehabilitation, Physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 31 Jan 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.
Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and progression.
In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been reported to be associated with FOG episodes. As the maintenance of gait depends on the precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral coordination may impair gait sequence, potentially causing freezing.
Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait. Aim of the study was to evaluate how the modulation of asymmetry through physical therapy might improve gait and FOG.
Detailed description
The patients will be'blind' to the study protocol and will be randomly assigned to one of the three study arms: 1) physiotherapy aimed to potentiate the more affected body side (worst side improvement, WSI); 2) physiotherapy aimed to potentiate the less affected body side (best side improvement, BSI); 3) physiotherapy aimed to potentiate both sides equally (standard treatment, ST). Each group will be undergo physiotherapy twice a week for three months. Each session will have duration of one hour and include a first part of warming up, a final part of cooling down (these two parts are the same for all the groups) and an active part (which is different from group to group). The active part includes exercises which are alike for all the groups but with a number of repetitions different from group to group according to the aim of potentiating the most affected side (WSI) or the least affected side (BSI) or both sides equally (in this case the number of repetitions was the same for both sides; ST). Medical treatment will be kept stable through all the study duration; medications are expressed as levodopa daily dose equivalent (LEDD).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Best Side Improvement | Experimental | Behavioral: Physical Therapy BSIPhysical Therapy BSI (Best Side Improvement), aimed to potentiate the less affected body side. |
| Worse side improvement | Experimental | Behavioral: Physical Therapy WSIPhysical Therapy WSI (Worst Side Improvement), aimed to potentiate the most affected body side. |
| Standard treatment | Active comparator | Behavioral: Physical Therapy STPhysical Therapy ST (Standard Treatment), aimed to potentiate both sides equally. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's disease, freezing of gait history, informed consent
Key exclusion criteria (1 listed)
- depression, severe orthopedic diseases
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 |
|---|---|---|
| Physical Therapy WSIEach session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the most affected side (WSI). | Behavioural | Worse side improvement |
| Physical Therapy BSIEach session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the least affected side (BSI). | Behavioural | Best Side Improvement |
| Physical Therapy STEach session has duration of one hour and includes a first part of warming up, a final part of cooling down and an active part that includes exercises with a number of repetitions according to the aim of potentiating both sides equally (ST). In this case the number of repetitions was the same for both sides. | Behavioural | Standard treatment |
Primary outcome
Motor Symptoms
Time frame: 24 weeks
1 secondary outcome
Freezing of gait
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Results publication: PubMed 21103799Modugno N, Iaconelli S, Fiorlli M, Lena F, Kusch I, Mirabella G. Active theater as a complementary therapy for Parkinson's disease rehabilitation: a pilot study. ScientificWorldJournal. 2010 Nov 16;10:2301-13. doi: 10.1100/tsw.2010.221.
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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.
Nicola Modugno, MD, PhD contact
Nicola Modugno, MD, PhD study chair
IRCCS NEUROMED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy WSI, Physical Therapy BSI and Physical Therapy ST in people with Parkinson's Disease, run by Neuromed IRCCS 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: status not confirmed, as of the sponsor's last update on 17 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Modugno, MD, PhD (nicusmod@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Symptoms (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051556, which also lists 1 linked publication.
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 17 Feb 2014.