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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01544738
Other study ID # LMNB-01
Secondary ID
Status Completed
Phase N/A
First received February 23, 2012
Last updated March 5, 2012
Start date November 2008

Study information

Verified date February 2012
Source Université Libre de Bruxelles
Contact n/a
Is FDA regulated No
Health authority Belgium: Ministry of Social Affairs, Public Health and the Environment
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
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.
Placebo stimulation
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

Locations

Country Name City State
Belgium ULB-FSM Laboratory of neurophysiology and movement biomechanics Brussels

Sponsors (3)

Lead Sponsor Collaborator
Université Libre de Bruxelles Belgium: Belgian Federal Science Policy Office (BELSPO), Belgium: Belgian National Fund for Scientific Research (FNRS)

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3D kinematic movement parameters and upper limb muscles electromyographic activation Participants will be followed for the duration of the clinical test (2 weeks) No
Secondary Unified Parkinson's Disease Rating Scale (UPDRS) Participants will be followed for the duration of the clinical test (2 weeks) No
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