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Status unknownNCT02731599Updated Apr 5, 2017

The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.

An interventional study of treadmill training with cues in Parkinson Disease, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2017-04-05.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jun 2014, registered Apr 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Sex
All
01

Study 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.

Read the detailed description

Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training with visual and auditory cues is useful in improving the gait's parameters in patients in early-moderate stages of disease. No data are available about the effectiveness of this training in those subjects in advanced stages of PD. 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.

150 patients with PD in early-moderate and advanced stages of disease (50 in H\&Y stage 2, group 1, 50 in H\&Y stage 3, group 2 and 50 in H\&Y stage 4, group 3) were enrolled. All patients underwent an intensive treatment: 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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson Disease
  • treadmill
  • Rehabilitation
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 150 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Parkinson Disease

Exclusion criteria

Exclusion Criteria:

comorbidity with other neurological condition

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    treadmill training

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

    Procedure: treadmill training with cues

Interventions

  • Proceduretreadmill training with cues

    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.

06

What researchers measure

Primary outcomes

  1. Length of step

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Ospedale Generale di zona Moriggia Pelascini
    Gravedona ed Uniti, Como 22015, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02731599
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible party
Ilaria Zivi (MD, Ospedale Generale Di Zona Moriggia-Pelascini) — Principal investigator
First posted
Apr 7, 2016
Start date
Jun 2014
Primary completion
Dec 2016
Completion
Jun 2017 (estimated)
Last update
Apr 5, 2017

Study contacts

Paola Ortelli
Contact
ortellipaola73@gmail.com
3332974872
Giuseppe Frazzitta
Contact
frazzitta64@gmail.com
+393442719916

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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