Weight in Lower Limbs Improves Gait Ataxia of in Machado-... | NCT02906046

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

NCT02906046

Sponsor

Federal University of Health Science of Porto Alegre

Status

Completed

Last Update Posted

Sep 19, 2016Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Machado-Joseph Disease

Interventions

Weight in Lower Limbs

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Aug 24, 2016

First Submission Date that Met QC Criteria

Sep 14, 2016

First Posted Date

Sep 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2016

Last Update Posted Date

Sep 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

giovana duarte eltz, Physiotherapist, Federal University of Health Science of Porto AlegrePrincipal Investigator

Lead Sponsor

Federal University of Health Science of Porto AlegreOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Weight in Lower Limbs	Device		0,5 kg Weight in Lower Limbs 1,0 kg Weight in Lower Limbs placebo Weight in Lower Limbs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Gait cadence analysis [cadence (steps/min) of walking for 10 meters away]		cadence (steps/min) of walking for 10 meters away in 1min timeout

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017827	Machado-Joseph Disease
D020234	Gait Ataxia

Ancestor Terms

ID	Term
D020754	Spinocerebellar Ataxias
D002524	Cerebellar Ataxia
D002526	Cerebellar Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014894	Weights and Measures

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided