Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatment treadmill training with cues
Sponsor Ospedale Generale Di Zona Moriggia-Pelascini
Start date June 2014
End date December 2016
Trial size 150 participants
Trial identifier NCT02731599, treadmill and PD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
20-minutes treadmill training per day, 6 times a week, for 4 weeks
treadmill 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.

Primary Outcomes

Measure
Length of step
time frame: 4 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Parkinson Disease Exclusion Criteria: comorbidity with other neurological condition

Additional Information

Official title The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ospedale Generale Di Zona Moriggia-Pelascini.