Parkinson's DiseaseASYMOTNCT02797496
Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease.
A study testing Asymmetric Motor Strengthening and Conventional therapy in people with Parkinson's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Asymmetric Motor Strengthening and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with Parkinson's disease on UKPDSBB criteria.
- Hoehn \& Yahr stage 2, 3 in "OFF" state
- Age ≥18 years
- Patient who agreed to sign an informed consent to participate in this study.
Who cannot join
- Patients who cannot or do not wish to follow a motor rehabilitation program for two months with a subsequent follow-up 3 months
- Intercurrent severe condition jeopardizing the vital or functional prognosis or the ability to participate in rehabilitation sessions.
- Cognitive dysfunction making effective communication or participation in a rehabilitation program impossible
- Person not benefiting from French State Health Insurance
- Current participation in another research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.
Parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years.
The training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in Parkinson's disease.
Read more
There is indeed in Parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. The hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate Parkinson's disease.
This is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects).
The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.
- Conditions
- Parkinson's Disease
- Being tested
- Asymmetric Motor Strengthening, Conventional therapy
- Keywords
- Parkinson's disease, Mild to moderate stage, Asymmetric Motor Strengthening, Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asymmetric Motor StrengtheningOther
In the Asymmetric Motor Strengthening program, the principle is to concomitantly reinforce the "body openers" and stretch the "body closers". One alternates two types of practice during a session. Active exercises consist of fatiguing series of rapid alternating movements against light weights working on movements of extension/abduction/external rotation/supination. Stretch postures consists of short 1-2 minutes bouts of flexor/internal rotator/adductor/pronator stretch. The duration of rehabilitation program is 8 weeks.
Conventional therapyOther
Conventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods.
| Study group | Role | What they receive |
|---|---|---|
| Asymmetric Motor Strengthening | Experimental | Not described Receives: Other: Asymmetric Motor Strengthening |
| Conventional Therapy | Active comparator | Not described Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60
Measured: Baseline (D1) and Day 60
Secondary outcomes (11)
UPDRS III score in " ON " medication state
Measured: Baseline (Day 1), Day 60 and Day 150
UPDRS III score in " OFF " medication state
Measured: Day 150
Speed and step length over 20 meters (with 2 turn around, 2 Stand up-Sit down and 2 Sit down-Stand up) at maximal speed in " OFF " medication state
Measured: Day 1, Day 60 and Day 150
Motor power of neck, elbow and knee extensors, measured using a portable dynamometer at Day 1, Day 60 and Day 150
Measured: Day 1, Day 60 and Day 150
Kinematic measurements of trunk inclination
Measured: Day 1 and Day 60
Balance measurement on posturography
Measured: Day 1 and Day 60
Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper)
Measured: Day 1, Day 60 and Day 150
Mount Sinai Parkinson Impairment Rating Scale
Measured: Day 1, Day 60 and Day 150
Global Mobility Task (GMT)
Measured: Day 1, Day 60 and Day 150
Geriatric Depression Scale - 15 items
Measured: Day 1, Day 60 and Day 150
Quality of life measured by PDQ-39
Measured: Day 1, Day 60 and Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startDec 2010
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel GRACIES, Md, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797496
- Sponsor's protocol ID
- P071236
- Other IDs
- 2009-A00669-48
- Acronym
- ASYMOT
- Status last verified
- Jan 2016
- First submitted
- 8 Jun 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT02797496
- Acronym / sponsor ID
- ASYMOT / P071236
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Mild to moderate stage, Asymmetric Motor Strengthening, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Jun 2016 (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 major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years.
The training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in Parkinson's disease.
There is indeed in Parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. The hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate Parkinson's disease.
This is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects).
The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymmetric Motor Strengthening | Experimental | Other: Asymmetric Motor Strengthening |
| Conventional Therapy | Active comparator | Other: Conventional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with Parkinson's disease on UKPDSBB criteria.
- Hoehn \& Yahr stage 2, 3 in "OFF" state
- Age ≥18 years
- Patient who agreed to sign an informed consent to participate in this study.
Key exclusion criteria (5 listed)
- Patients who cannot or do not wish to follow a motor rehabilitation program for two months with a subsequent follow-up 3 months
- Intercurrent severe condition jeopardizing the vital or functional prognosis or the ability to participate in rehabilitation sessions.
- Cognitive dysfunction making effective communication or participation in a rehabilitation program impossible
- Person not benefiting from French State Health Insurance
- Current participation in another research protocol
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 |
|---|---|---|
| Asymmetric Motor StrengtheningIn the Asymmetric Motor Strengthening program, the principle is to concomitantly reinforce the "body openers" and stretch the "body closers". One alternates two types of practice during a session. Active exercises consist of fatiguing series of rapid alternating movements against light weights working on movements of extension/abduction/external rotation/supination. Stretch postures consists of short 1-2 minutes bouts of flexor/internal rotator/adductor/pronator stretch. The duration of rehabilitation program is 8 weeks. | Other | Asymmetric Motor Strengthening |
| Conventional therapyConventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods. | Other | Conventional Therapy |
Primary outcome
Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60
Time frame: Baseline (D1) and Day 60
11 secondary outcomes
UPDRS III score in " ON " medication state
Time frame: Baseline (Day 1), Day 60 and Day 150
UPDRS III score in " OFF " medication state
Time frame: Day 150
Speed and step length over 20 meters (with 2 turn around, 2 Stand up-Sit down and 2 Sit down-Stand up) at maximal speed in " OFF " medication state
Time frame: Day 1, Day 60 and Day 150
Motor power of neck, elbow and knee extensors, measured using a portable dynamometer at Day 1, Day 60 and Day 150
Time frame: Day 1, Day 60 and Day 150
Kinematic measurements of trunk inclination
Time frame: Day 1 and Day 60
Balance measurement on posturography
Time frame: Day 1 and Day 60
Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper)
Time frame: Day 1, Day 60 and Day 150
Mount Sinai Parkinson Impairment Rating Scale
Time frame: Day 1, Day 60 and Day 150
Global Mobility Task (GMT)
Time frame: Day 1, Day 60 and Day 150
Geriatric Depression Scale - 15 items
Time frame: Day 1, Day 60 and Day 150
Quality of life measured by PDQ-39
Time frame: Day 1, Day 60 and Day 150
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 13 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Michel GRACIES, Md, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asymmetric Motor Strengthening and Conventional therapy in people with Parkinson's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 5 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 13 Jun 2016. 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 France. 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?
Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60 (time frame: Baseline (D1) and Day 60). 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 13 Jun 2016.