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

Federal University of Health Science of Porto Alegre

Status: Completed

Conditions: Machado-Joseph Disease

Treatments: Device: Weight in Lower Limbs

Study type: Interventional

Funder types: Other

Identifiers

NCT02906046

989/12

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 3 patient groups, including a placebo group

placebo Weight in Lower Limbs

Placebo Comparator group

Description:

placebo Weight in Lower Limbs

Treatment:

Device: Weight in Lower Limbs

0,5 kg Weight in Lower Limbs

Other group

Description:

0,5 kg Weight in Lower Limbs

Treatment:

Device: Weight in Lower Limbs

1,0 kg Weight in Lower Limbs

Other group

Description:

1,0 kg Weight in Lower Limbs

Treatment:

Device: Weight in Lower Limbs