- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01544738
Sensory Stimulation Effect on Movement Speed in Patients With Parkinson Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussels, Belgium, 1070
- ULB-FSM Laboratory of neurophysiology and movement biomechanics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of Parkinson Disease
Exclusion Criteria:
- Patients with a limitation in the shoulder range of motion necessary to perform pointing movements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Aponeurotic stimulation group
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.
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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.
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Active Comparator: Placebo stimulation group
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
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Participants will be followed for the duration of the clinical test (2 weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Participants will be followed for the duration of the clinical test (2 weeks)
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Participants will be followed for the duration of the clinical test (2 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Bengoetxea, PhD, Université libre de Bruxelles
- Study Chair: Françoise Leurs, PhD Student, Université libre de Bruxelles
- Study Chair: Leslie Rigal, Master Student, Université libre de Bruxelles
- Study Director: Guy Cheron, PhD, Université libre de Bruxelles
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMNB-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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