Working on Asymmetry in Parkinson's Disease

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Physical Therapy BSI; Behavioral: Physical Therapy WSI; Behavioral: Physical Therapy ST

• Registration Number: NCT02051556
• Lead Sponsor: Neuromed IRCCS

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-14
• Last Update Posted: 2014-02-17
• Study Start: 2014-03
• Primary Completion: 2014-06
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

• depression, severe orthopedic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best Side Improvement	Physical Therapy BSI	Physical Therapy BSI (Best Side Improvement), aimed to potentiate the less affected body side.
Worse side improvement	Physical Therapy WSI	Physical Therapy WSI (Worst Side Improvement), aimed to potentiate the most affected body side.
Standard treatment	Physical Therapy ST	Physical Therapy ST (Standard Treatment), aimed to potentiate both sides equally.

Primary Outcome Measures

Name	Time	Method
Motor Symptoms	24 weeks

Secondary Outcome Measures

Name	Time	Method
Freezing of gait	24 weeks

Trial Locations

Locations (1)

Irccs Neuromed; 🇮🇹 Pozzilli, Isernia, Italy