NCT02731599

Brief Summary

The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn \& Yahr (H\&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.

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
150

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable parkinson-disease

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

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

April 3, 2016

Last Update Submit

April 3, 2017

Conditions

Keywords

Parkinson DiseasetreadmillRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Length of step

    4 weeks

Study Arms (1)

treadmill training

EXPERIMENTAL

20-minutes treadmill training per day, 6 times a week, for 4 weeks

Procedure: treadmill training with cues

Interventions

20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.

treadmill training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson Disease

You may not qualify if:

  • comorbidity with other neurological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Generale di zona Moriggia Pelascini

Gravedona Ed Uniti, Como, 22015, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 3, 2016

First Posted

April 7, 2016

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations