NCT02051556

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 17, 2014

Status Verified

February 1, 2014

Enrollment Period

3 months

First QC Date

January 16, 2014

Last Update Submit

February 14, 2014

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseFreezing of gaitAsymmetryRehabilitationPhysical therapy

Outcome Measures

Primary Outcomes (1)

  • Motor Symptoms

    24 weeks

Secondary Outcomes (1)

  • Freezing of gait

    24 weeks

Other Outcomes (1)

  • Short physical performance battery

    24 weeks

Study Arms (3)

Best Side Improvement

EXPERIMENTAL

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

Behavioral: Physical Therapy BSI

Worse side improvement

EXPERIMENTAL

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

Behavioral: Physical Therapy WSI

Standard treatment

ACTIVE COMPARATOR

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

Behavioral: Physical Therapy ST

Interventions

Physical Therapy WSIBEHAVIORAL

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).

Worse side improvement
Physical Therapy BSIBEHAVIORAL

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).

Best Side Improvement
Physical Therapy STBEHAVIORAL

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.

Standard treatment

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • depression, severe orthopedic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Neuromed

Pozzilli, Isernia, 86170, Italy

Location

Related 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.

    PMID: 21103799RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Nicola Modugno, MD, PhD

    IRCCS NEUROMED

    STUDY CHAIR

Central Study Contacts

Nicola Modugno, MD, PhD

CONTACT

nicusmod@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 31, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

February 17, 2014

Record last verified: 2014-02

Locations

IT(1)