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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Machado-Joseph Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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placebo Weight in Lower Limbs

Group Type PLACEBO_COMPARATOR

Weight in Lower Limbs

Intervention Type DEVICE

0,5 kg Weight in Lower Limbs

Group Type OTHER

Weight in Lower Limbs

Intervention Type DEVICE

1,0 kg Weight in Lower Limbs

Group Type OTHER

Weight in Lower Limbs

Intervention Type DEVICE

Interventions

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Weight in Lower Limbs

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No