Parkinson DiseaseNCT01544738
Sensory Stimulation Effect on Movement Speed in Patients With Parkinson Disease
A study testing Aponeurotic stimulation (the diacutaneous fibrolysis method) in people with Parkinson Disease, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease (PD). Several studies have shown that patients with PD exhibit slowness because they are unable to modulate, in an optimal way, the velocity of voluntary motor acts not induced by external stimulation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Aponeurotic stimulation (the diacutaneous fibrolysis method)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2008to May 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson Disease
Who cannot join
- Patients with a limitation in the shoulder range of motion necessary to perform pointing movements
Trial locations and contacts
1 site in 1 country.
Belgium1 site
ULB-FSM Laboratory of neurophysiology and movement biomechanics
Brussels, 1070
About this study
Official title: Aponeurotic Stimulation Effect on Parkinson Bradykinesia
Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease (PD). Several studies have shown that patients with PD exhibit slowness because they are unable to modulate, in an optimal way, the velocity of voluntary motor acts not induced by external stimulation. Indeed, these patients have difficulties to integrate multi-sensorial information, mainly proprioception.
The investigators investigated changes in shoulder velocity during pointing movements by patients with PD after stimulation of soft tissues (aponeurosis) of upper limb muscles. The stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the aponeurotic tissues enrobing the heads of the upper limb muscles. This technique has previously been shown to decrease passive tension and the tendon reflex response of the manipulated muscle group. The investigators hypothesis is that aponeurotic manipulation of shoulder muscles therefore creates a modification in the proprioceptive information, which in return temporarily decreases the bradykinesia of shoulder movements.
- Conditions
- Parkinson Disease
- Being tested
- Aponeurotic stimulation (the diacutaneous fibrolysis method), Placebo stimulation
- Keywords
- Parkinson Disease, sensory stimulation, Bradykinesia
- Medical subject headings
- Parkinson Disease, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aponeurotic stimulation (the diacutaneous fibrolysis method)Other
Treatment consisted of manipulating, with a hook, the aponeurotic tissues enrobing the heads of the upper-limb muscles. The manipulation consisted of back and forth mobilization, applied perpendicularly to the axis of the muscular fibers. The mobilization is performed with both hands; the therapist's non-dominant hand performs a manual mobilization whereas the dominant hand follows the movement with the hook. The hook allows the therapist to be very precise about the location of the tissues that are stretched. This stretch is realized at the level of the aponeurotic fibers presenting the greatest resistance to perpendicular movement. The shape of the hook is chosen to avoid discomfort or pain during manipulation. To spread the pressure exerted by the spatula on a very local point, it is important to fill completely the curved part of the hook with the adjacent soft tissues. We manipulated muscle from the proximal insertion towards the distal, giving special attention to the tendons.
Placebo stimulationOther
Placebo stimulation (PS) consisted of manipulating the skin along the same paths over the trunk, shoulder and arm muscles that were the targets for treatment in the AS group
| Study group | Role | What they receive |
|---|---|---|
| Aponeurotic stimulation group | Experimental | The stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the aponeurotic tissues enrobing the heads of the trunk and upper limb muscles. Receives: Other: Aponeurotic stimulation (the diacutaneous fibrolysis method) |
| Placebo stimulation group | Active comparator | Placebo stimulation (PS) consisted of manipulating the skin along the same paths over the trunk, shoulder and arm muscles that were the targets for treatment in the Aponeurotic stimulation group. Receives: Other: Placebo stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D kinematic movement parameters and upper limb muscles electromyographic activation
Measured: Participants will be followed for the duration of the clinical test (2 weeks)
Secondary outcomes (1)
Unified Parkinson's Disease Rating Scale (UPDRS)
Measured: Participants will be followed for the duration of the clinical test (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startNov 2008
- Primary completionMay 2009
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, Belgium: Belgian Federal Science Policy Office (BELSPO)
- Responsible party
- Principal investigator, Ana Bengoetxea, Université Libre de Bruxelles
- Investigators
- Ana Bengoetxea, PhD, Principal investigator, Université Libre de BruxellesFrançoise Leurs, PhD Student, Study chair, Université Libre de BruxellesLeslie Rigal, Master Student, Study chair, Université Libre de BruxellesGuy Cheron, PhD, Study director, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544738
- Sponsor's protocol ID
- LMNB-01
- Status last verified
- Feb 2012
- First submitted
- 23 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aponeurotic Stimulation Effect on Parkinson Bradykinesia
- ClinicalTrials.gov ID
- NCT01544738
- Acronym / sponsor ID
- LMNB-01
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, sensory stimulation, Bradykinesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, Belgium: Belgian Federal Science Policy Office (BELSPO)
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- First posted
- 6 Mar 2012 (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.
Movement slowness (bradykinesia) is one of the main motor symptoms in Parkinson Disease (PD). Several studies have shown that patients with PD exhibit slowness because they are unable to modulate, in an optimal way, the velocity of voluntary motor acts not induced by external stimulation. Indeed, these patients have difficulties to integrate multi-sensorial information, mainly proprioception.
The investigators investigated changes in shoulder velocity during pointing movements by patients with PD after stimulation of soft tissues (aponeurosis) of upper limb muscles. The stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the aponeurotic tissues enrobing the heads of the upper limb muscles. This technique has previously been shown to decrease passive tension and the tendon reflex response of the manipulated muscle group. The investigators hypothesis is that aponeurotic manipulation of shoulder muscles therefore creates a modification in the proprioceptive information, which in return temporarily decreases the bradykinesia of shoulder movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aponeurotic stimulation group | Experimental | Other: Aponeurotic stimulation (the diacutaneous fibrolysis method)The stimulation consisted of manipulating, with a hook (the diacutaneous fibrolysis method), the aponeurotic tissues enrobing the heads of the trunk and upper limb muscles. |
| Placebo stimulation group | Active comparator | Other: Placebo stimulationPlacebo stimulation (PS) consisted of manipulating the skin along the same paths over the trunk, shoulder and arm muscles that were the targets for treatment in the Aponeurotic stimulation group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson Disease
Key exclusion criteria (1 listed)
- Patients with a limitation in the shoulder range of motion necessary to perform pointing movements
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 |
|---|---|---|
| Aponeurotic stimulation (the diacutaneous fibrolysis method)Treatment consisted of manipulating, with a hook, the aponeurotic tissues enrobing the heads of the upper-limb muscles. The manipulation consisted of back and forth mobilization, applied perpendicularly to the axis of the muscular fibers. The mobilization is performed with both hands; the therapist's non-dominant hand performs a manual mobilization whereas the dominant hand follows the movement with the hook. The hook allows the therapist to be very precise about the location of the tissues that are stretched. This stretch is realized at the level of the aponeurotic fibers presenting the greatest resistance to perpendicular movement. The shape of the hook is chosen to avoid discomfort or pain during manipulation. To spread the pressure exerted by the spatula on a very local point, it is important to fill completely the curved part of the hook with the adjacent soft tissues. We manipulated muscle from the proximal insertion towards the distal, giving special attention to the tendons. | Other | Aponeurotic stimulation group |
| Placebo stimulationPlacebo stimulation (PS) consisted of manipulating the skin along the same paths over the trunk, shoulder and arm muscles that were the targets for treatment in the AS group | Other | Placebo stimulation group |
Primary outcome
3D kinematic movement parameters and upper limb muscles electromyographic activation
Time frame: Participants will be followed for the duration of the clinical test (2 weeks)
1 secondary outcome
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Participants will be followed for the duration of the clinical test (2 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 6 Mar 2012.
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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.
Ana Bengoetxea, PhD principal investigator
Université Libre de Bruxelles
Françoise Leurs, PhD Student study chair
Université Libre de Bruxelles
Leslie Rigal, Master Student study chair
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aponeurotic stimulation (the diacutaneous fibrolysis method) in people with Parkinson Disease, run by Université Libre de Bruxelles at 1 site in Belgium.
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 6 Mar 2012. 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 Belgium. 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?
3D kinematic movement parameters and upper limb muscles electromyographic activation (time frame: Participants will be followed for the duration of the clinical test (2 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 6 Mar 2012.