Machado-Joseph DiseaseNCT02906046
Weight in Lower Limbs Improves Gait Ataxia of in Machado-Joseph Disease Patients
A study testing Weight in Lower Limbs in people with Machado-Joseph Disease, run by Federal University of Health Science of Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Machado-Joseph Disease
- What is being tested?
- Weight in Lower Limbs
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should have between 18 and 65 years of age and independent gait
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Machado-Joseph Disease
- Being tested
- Weight in Lower Limbs
- Keywords
- SCA 3, Ataxic Gait
- Medical subject headings
- Machado-Joseph Disease, Gait Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight in Lower LimbsDevice
| Study group | Role | What they receive |
|---|---|---|
| placebo Weight in Lower Limbs | Placebo comparator | placebo Weight in Lower Limbs Receives: Device: Weight in Lower Limbs |
| 0,5 kg Weight in Lower Limbs | Other | 0,5 kg Weight in Lower Limbs Receives: Device: Weight in Lower Limbs |
| 1,0 kg Weight in Lower Limbs | Other | 1,0 kg Weight in Lower Limbs Receives: Device: Weight in Lower Limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed analysis [speed (mt/min) of walking for 10 meters away]
Measured: 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]
Measured: cadence (steps/min) of walking for 10 meters away in 1min timeout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startApr 2012
- Primary completionFeb 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Machado-Joseph DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, giovana duarte eltz, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906046
- Sponsor's protocol ID
- 989/12
- Status last verified
- Jan 2013
- First submitted
- 24 Aug 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight in Lower Limbs Improves Gait Ataxia Of in Machado-Joseph Disease Patients: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02906046
- Acronym / sponsor ID
- 989/12
- Conditions
- Machado-Joseph Disease
- Keywords
- SCA 3, Ataxic Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo Weight in Lower Limbs | Placebo comparator | Device: Weight in Lower Limbsplacebo Weight in Lower Limbs |
| 0,5 kg Weight in Lower Limbs | Other | Device: Weight in Lower Limbs0,5 kg Weight in Lower Limbs |
| 1,0 kg Weight in Lower Limbs | Other | Device: Weight in Lower Limbs1,0 kg Weight in Lower Limbs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients should have between 18 and 65 years of age and independent gait
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight in Lower Limbs | Device | 0,5 kg Weight in Lower Limbs, 1,0 kg Weight in Lower Limbs, placebo Weight in Lower Limbs |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Weight in Lower Limbs in people with Machado-Joseph Disease, run by Federal University of Health Science of Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.