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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731599
• Other study ID #: treadmill and PD
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2016
• Last updated: April 3, 2017
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: April 2017
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: Paola Ortelli
• Phone: 3332974872
• Email: ortellipaola73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Parkinson Disease

Exclusion Criteria:

comorbidity with other neurological condition

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	Ospedale Generale di zona Moriggia Pelascini	Gravedona ed Uniti	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of step		4 weeks