NCT01544738

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
Last Updated

March 6, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

February 23, 2012

Last Update Submit

March 5, 2012

Conditions

Keywords

Parkinson Diseasesensory stimulationBradykinesia

Outcome Measures

Primary Outcomes (1)

  • 3D kinematic movement parameters and upper limb muscles electromyographic activation

    Participants will be followed for the duration of the clinical test (2 weeks)

Secondary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    Participants will be followed for the duration of the clinical test (2 weeks)

Study Arms (2)

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.

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.

Other: Placebo stimulation

Interventions

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.

Aponeurotic 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 AS group

Placebo stimulation group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Parkinson Disease

You may not qualify if:

  • Patients with a limitation in the shoulder range of motion necessary to perform pointing movements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULB-FSM Laboratory of neurophysiology and movement biomechanics

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Parkinson DiseaseHypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Bengoetxea, PhD

    Université Libre de Bruxelles

    PRINCIPAL INVESTIGATOR
  • Françoise Leurs, PhD Student

    Université Libre de Bruxelles

    STUDY CHAIR
  • Leslie Rigal, Master Student

    Université Libre de Bruxelles

    STUDY CHAIR
  • Guy Cheron, PhD

    Université Libre de Bruxelles

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 23, 2012

First Posted

March 6, 2012

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Last Updated

March 6, 2012

Record last verified: 2012-02

Locations