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

Primary Purpose

Machado-Joseph Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weight in Lower Limbs
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Machado-Joseph Disease focused on measuring SCA 3, Ataxic Gait

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Other

    Other

    Arm Label

    placebo Weight in Lower Limbs

    0,5 kg Weight in Lower Limbs

    1,0 kg Weight in Lower Limbs

    Arm Description

    placebo Weight in Lower Limbs

    0,5 kg Weight in Lower Limbs

    1,0 kg Weight in Lower Limbs

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 24, 2016
    Last Updated
    September 14, 2016
    Sponsor
    Federal University of Health Science of Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02906046
    Brief Title
    Weight in Lower Limbs Improves Gait Ataxia of in Machado-Joseph Disease Patients
    Official Title
    Weight in Lower Limbs Improves Gait Ataxia Of in Machado-Joseph Disease Patients: A Randomized Crossover Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Machado-Joseph Disease
    Keywords
    SCA 3, Ataxic Gait

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo Weight in Lower Limbs
    Arm Type
    Placebo Comparator
    Arm Description
    placebo Weight in Lower Limbs
    Arm Title
    0,5 kg Weight in Lower Limbs
    Arm Type
    Other
    Arm Description
    0,5 kg Weight in Lower Limbs
    Arm Title
    1,0 kg Weight in Lower Limbs
    Arm Type
    Other
    Arm Description
    1,0 kg Weight in Lower Limbs
    Intervention Type
    Device
    Intervention Name(s)
    Weight in Lower Limbs
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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

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