Working on Asymmetry in Parkinson's Disease

Neuromed IRCCS

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Behavioral: Physical Therapy WSI; Behavioral: Physical Therapy ST; Behavioral: Physical Therapy BSI

Study type: Interventional

Funder types: Other

Identifiers

NCT02051556

ASPD-01

Details and patient eligibility

About

Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and progression.

In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been reported to be associated with FOG episodes. As the maintenance of gait depends on the precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral coordination may impair gait sequence, potentially causing freezing.

Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait. Aim of the study was to evaluate how the modulation of asymmetry through physical therapy might improve gait and FOG.

Full description

The patients will be'blind' to the study protocol and will be randomly assigned to one of the three study arms: 1) physiotherapy aimed to potentiate the more affected body side (worst side improvement, WSI); 2) physiotherapy aimed to potentiate the less affected body side (best side improvement, BSI); 3) physiotherapy aimed to potentiate both sides equally (standard treatment, ST). Each group will be undergo physiotherapy twice a week for three months. Each session will have duration of one hour and include a first part of warming up, a final part of cooling down (these two parts are the same for all the groups) and an active part (which is different from group to group). The active part includes exercises which are alike for all the groups but with a number of repetitions different from group to group according to the aim of potentiating the most affected side (WSI) or the least affected side (BSI) or both sides equally (in this case the number of repetitions was the same for both sides; ST). Medical treatment will be kept stable through all the study duration; medications are expressed as levodopa daily dose equivalent (LEDD).

Enrollment: 42 estimated patients

Sex: All

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parkinson's disease, freezing of gait history, informed consent

Exclusion criteria

• depression, severe orthopedic diseases

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups

Best Side Improvement

Experimental group

Description:

Physical Therapy BSI (Best Side Improvement), aimed to potentiate the less affected body side.

Treatment:

Behavioral: Physical Therapy BSI

Worse side improvement

Experimental group

Description:

Physical Therapy WSI (Worst Side Improvement), aimed to potentiate the most affected body side.

Treatment:

Behavioral: Physical Therapy WSI

Standard treatment

Active Comparator group

Description:

Physical Therapy ST (Standard Treatment), aimed to potentiate both sides equally.

Treatment:

Behavioral: Physical Therapy ST