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Working on Asymmetry in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Physical Therapy WSI
Physical Therapy BSI
Physical Therapy ST
Sponsored by
Neuromed IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's disease, Freezing of gait, Asymmetry, Rehabilitation, Physical therapy

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • depression, severe orthopedic diseases

Sites / Locations

  • Irccs Neuromed

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Best Side Improvement

Worse side improvement

Standard treatment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Motor Symptoms

Secondary Outcome Measures

Freezing of gait

Full Information

First Posted
January 16, 2014
Last Updated
February 14, 2014
Sponsor
Neuromed IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT02051556
Brief Title
Working on Asymmetry in Parkinson's Disease
Official Title
Working on Asymmetry in Parkinson's Disease: a Double Blind, Randomized, Controlled Rehabilitation Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuromed IRCCS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Freezing of gait, Asymmetry, Rehabilitation, Physical therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Best Side Improvement
Arm Type
Experimental
Arm Description
Physical Therapy BSI (Best Side Improvement), aimed to potentiate the less affected body side.
Arm Title
Worse side improvement
Arm Type
Experimental
Arm Description
Physical Therapy WSI (Worst Side Improvement), aimed to potentiate the most affected body side.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Physical Therapy ST (Standard Treatment), aimed to potentiate both sides equally.
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy WSI
Intervention Description
Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the most affected side (WSI).
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy BSI
Intervention Description
Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the least affected side (BSI).
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy ST
Intervention Description
Each session has duration of one hour and includes a first part of warming up, a final part of cooling down and an active part that includes exercises with a number of repetitions according to the aim of potentiating both sides equally (ST). In this case the number of repetitions was the same for both sides.
Primary Outcome Measure Information:
Title
Motor Symptoms
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Freezing of gait
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Short physical performance battery
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson's disease, freezing of gait history, informed consent Exclusion Criteria: depression, severe orthopedic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Modugno, MD, PhD
Email
nicusmod@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Modugno, MD, PhD
Organizational Affiliation
IRCCS NEUROMED
Official's Role
Study Chair
Facility Information:
Facility Name
Irccs Neuromed
City
Pozzilli
State/Province
Isernia
ZIP/Postal Code
86170
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21103799
Citation
Modugno N, Iaconelli S, Fiorlli M, Lena F, Kusch I, Mirabella G. Active theater as a complementary therapy for Parkinson's disease rehabilitation: a pilot study. ScientificWorldJournal. 2010 Nov 16;10:2301-13. doi: 10.1100/tsw.2010.221.
Results Reference
result
Links:
URL
http://www.hindawi.com/journals/tswj/2010/651594/abs/
Description
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Working on Asymmetry in Parkinson's Disease

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