Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-07-31

Brief Summary

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Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism underlying these phenomena is still an open debate. Apart from the motor correlates, cognitive-attentional impairment and somatosensory deficits (especially in the proprioceptive system) may underlie these motor blocks. The current study aims to unravel whether the proprioceptive system is involved by manipulating task-relevant or non-relevant proprioceptive stimuli.

Hence, the main aims of this study are:

(i) to assess the somatosensory function in people with PD that experience freezing of gait FOG and (ii) to investigate the effects of manipulating both proprioception and attentional resources on FOUL severity.

Forty-five people will be assigned to three age-matched groups (N=15 each): healthy elderly, PD patients that experience FOG (FOG+) and PD patients that do not experience FOG. Cutaneous sensory function and kinesthetic ability will be assessed by means of standardized user-friendly methods and precise repositioning measures using the VICON motion analysis. Additionally, participants will perform a newly developed task that can successfully elicit FOULs (a handwriting freezing-provoking task) on a custom tablet (Heremans et al 2015). The task will be performed without and with the use of muscle vibration (a well-known method to stimulate the proprioceptive system). The investigators will manipulate both the timing of vibration (relevant - after FOUL onset; or non-relevant: before FOUL onset) and the region of stimulation (neutral: on a bone-mark where there is little if any proprioceptive stimulation; and on a non-neutral spot: on the forearm muscles). It is believed that FOG+ will present with worse somatosensory function than those who do not experience motor blocks (especially in the proprioceptive system). Additionally, the Investigators expect a reduction in FOUL severity (e.g. FOUL duration) when vibration is applied in a task-relevant way, independently of the region stimulated. In contrast, it is also expected that when vibration is applied in a non-relevant way and it may act as a distractor, FOUL duration will increase. This study will thus be able to distinguish between the contribution of attentional and proprioceptive resources to the mechanism of motor blocks in PD.

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Detailed Description

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Conditions

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Parkinson's Disease Somatosensory Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vibration Relevant

Vibration applied on the muscle belly after 'motor block' onset

Group Type ACTIVE_COMPARATOR

Mechanical stimulus (vibration) applied on the forearm

Intervention Type DEVICE

Local vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name.

Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports.

Neutral Vibration Relevant

Vibration applied on a bony mark after 'motor block' onset

Group Type ACTIVE_COMPARATOR

Mechanical stimulus (vibration) applied on the forearm

Intervention Type DEVICE

Local vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name.

Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports.

Neutral Vibration Non-Relevant

Vibration applied on a bony mark before 'motor block' onset

Group Type ACTIVE_COMPARATOR

Mechanical stimulus (vibration) applied on the forearm

Intervention Type DEVICE

Local vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name.

Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports.

Vibration Non-Relevant

Vibration applied on the muscle belly after 'motor block' onset

Group Type ACTIVE_COMPARATOR

Mechanical stimulus (vibration) applied on the forearm

Intervention Type DEVICE

Local vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name.

Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports.

No Vibration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mechanical stimulus (vibration) applied on the forearm

Local vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name.

Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* PD patients (N=30):
* Diagnosis of PD based on the UK PD brain bank criteria
* Hoehn \& Yahr stage II-III (ON-medication)

Exclusion Criteria

* Cognitive dysfunction Score on the Mini Mental State Examination (MMSE) \< 23/30
* Medication change in the past 1 month
* Other neurological disorders
* Vestibular disorder
* Uncontrolled diabetes
* Cutaneous diseases
* Left-handedness

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes