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

NCT02906046 | Completed

• 1 other identifier: 989/12
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Machado-Joseph Disease

Keywords

SCA 3; Ataxic Gait

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

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

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

Study Arms (3)

placebo Weight in Lower Limbs

PLACEBO COMPARATOR

placebo Weight in Lower Limbs

Device: Weight in Lower Limbs

0,5 kg Weight in Lower Limbs

OTHER

0,5 kg Weight in Lower Limbs

Device: Weight in Lower Limbs

1,0 kg Weight in Lower Limbs

OTHER

1,0 kg Weight in Lower Limbs

Device: Weight in Lower Limbs

Interventions

Weight in Lower Limbs DEVICE

0,5 kg Weight in Lower Limbs; 1,0 kg Weight in Lower Limbs; placebo Weight in Lower Limbs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

MeSH Terms

Conditions

Machado-Joseph Disease; Gait Ataxia

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 19, 2016
• Study Start: April 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 19, 2016

Record last verified: 2013-01