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

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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Key information

Conditions

Machado-Joseph Disease Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Gait Ataxia Gait Disorders, Neurologic Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinocerebellar Ataxias Spinocerebellar Degenerations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight in Lower Limbs

Device

Primary outcomes

Gait speed analysis [speed (mt/min) of walking for 10 meters away]

Time frame: speed (mt/min) of walking for 10 meters away in 1min timeout

Secondary outcomes

Gait cadence analysis [cadence (steps/min) of walking for 10 meters away]

Time frame: cadence (steps/min) of walking for 10 meters away in 1min timeout

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Sep 19, 2016
Registry last updated: Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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