Weight in Lower Limbs Improves Gait Ataxia of in Machado-Joseph Disease Patients

Machado-Joseph Disease Clinical Trial

Official title:

Weight in Lower Limbs Improves Gait Ataxia Of in Machado-Joseph Disease Patients: A Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906046
• Other study ID #: 989/12
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: September 14, 2016
• Start date: April 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2013
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Federal University of Health Sciences of Porto Alegre.
• Study type: Interventional

Clinical Trial Summary

Few studies evaluated the efficacy of adding weights on the lower limbs in patients with ataxic disorders. There is no current evidence on which would be the most appropriate weight for use in this context. To assess progress and benefits of using this load, gait of symptomatic carriers of spinocerebellar ataxia type 3/Machado Joseph disease the objective of the study is to evaluate the gait with and without different load weights on lower limbs. Outcomes were the Scale for the Assessment and Ataxia Rating of (SARA), kinematic gait assessment by the accelerometer and gyroscope and the Patient Global Impression (PGI) about which weight they prefer for walking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients should have between 18 and 65 years of age and independent gait

Exclusion Criteria:

• Were the need of assistive devices for walking = 10m (such as crutches, wheelchairs and orthotics)

• Item gait of Scale for the Assessment and Rating of Ataxia (SARA)19=, presence of other neurological disease that affect motor system

• Orthopedic impairments of lower limbs (fractures or surgeries in the past 6 months)

• Difference between the lower limbs greater than 3.0 cm

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gait Ataxia
• Machado-Joseph Disease

Intervention

Device:
• Weight in Lower Limbs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed analysis [speed (mt/min) of walking for 10 meters away]		speed (mt/min) of walking for 10 meters away in 1min timeout	No
Secondary	Gait cadence analysis [cadence (steps/min) of walking for 10 meters away]		cadence (steps/min) of walking for 10 meters away in 1min timeout	No