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

September 14, 2016 updated by: giovana duarte eltz, Federal University of Health Science of Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo Weight in Lower Limbs
Device: Weight in Lower Limbs
Other: 0,5 kg Weight in Lower Limbs
Device: Weight in Lower Limbs
Other: 1,0 kg Weight in Lower Limbs
Device: Weight in Lower Limbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
speed (mt/min) of walking for 10 meters away in 1min timeout

Secondary Outcome Measures

Outcome Measure
Time Frame
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
cadence (steps/min) of walking for 10 meters away in 1min timeout

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 989/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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