Working on Asymmetry in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Working on Asymmetry in Parkinson's Disease: a Double Blind, Randomized, Controlled Rehabilitation Trial.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02051556
• Other study ID #: ASPD-01
• Status: Unknown status
• Phase: N/A
• First received: January 16, 2014
• Last updated: February 14, 2014
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2014
• Source: Neuromed IRCCS
• Contact: Nicola Modugno, MD, PhD
• Email: nicusmod[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 42
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• depression, severe orthopedic diseases

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Physical Therapy WSI
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).
• Physical Therapy BSI
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).
• Physical Therapy ST
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.

Locations

Country	Name	City	State
Italy	Irccs Neuromed	Pozzilli	Isernia

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short physical performance battery		24 weeks
Primary	Motor Symptoms		24 weeks
Secondary	Freezing of gait		24 weeks

External Links

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