StrokeNCT02113098
Effects of Treadmill Gait Training With Loading in Individuals With Stroke
A study testing Treadmill, ankle load and Treadmill in people with Stroke and Gait Disorders, Neurologic, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stroke, Gait Disorders, Neurologic
- What is being tested?
- Treadmill, ankle load and Treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Oct 2015
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First episode of stroke (ischemic or hemorrhagic) which determined unilateral hemiparesis
- Time of lesion less one year
- Able to walk independently by 10 feet on flat surface without the use of assistive devices
- Gait speed less than 0.8 m / s
- Ability to understand and obey simple commands
Who cannot join
- Instability of cardiac conditions
- Adverse clinical conditions affecting balance and / or gait
- Pain and / or severe discomfort that impede the realization of the proposed activities
- Decompensation in systemic blood pressure, with the systolic and diastolic values above 200 mmHg and 110 mmHg, respectively, before and / or after training
- Submaximal heart rate above the allowed values during training
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte, 59072-970
About this study
Official title: Effects of Treadmill Gait Training With Adding Load on Lower Limb of Individuals With Stroke
The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke.
Read the detailed description
This is a randomized and blinded clinical trial, in which participants are being randomly divided into experimental group and control group, in order to verify the effects of adding load on gait symmetry after stroke. 40 individuals will participate, and the calculation of sample size was performed from the ratio variable symmetry of swing time, based on previous study. Whereas about 15% of individuals could give up to participate in the study during their course (dropout rate), we determined a number of 20 participants in each group.
- Conditions
- Stroke, Gait Disorders, Neurologic
- Being tested
- Treadmill, ankle load, Treadmill
- Keywords
- Stroke, Gait, Rehabilitation
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill, ankle loadOther
The experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks
TreadmillOther
The control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Treadmill, ankle load | Experimental | The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb Receives: Other: Treadmill, ankle load |
| Treadmill | Active comparator | The control group (active comparator) will perform gait training on a treadmill Receives: Other: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ground reaction force, in Newtons
Vertical component of ground reaction force, measured using a force platform
Measured: Until one year after stroke
Angular displacements of hip, knee and ankle (in degrees)
Angular gait variables, measured by a system of movement analysis.
Measured: Until one year after stroke
Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)
Spatiotemporal gait variable, measured by a system of movement analysis
Measured: Until one year after stroke
Secondary outcomes (4)
speed (meters/second)
Spatiotemporal gait variable, measured by a system of movement analysis
Measured: Until one year after stroke
double support time (in seconds)
Spatiotemporal gait variable, measured by a system of movement analysis
Measured: Until one year after stroke
step length (in meters)
Spatiotemporal gait variable, measured by a system of movement analysis
Measured: Until one year after stroke
stride length (in meters)
Spatiotemporal gait variable, measured by a system of movement analysis
Measured: Until one year after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Raquel Rodrigues Lindquist, PhD, Universidade Federal do Rio Grande do Norte
- Investigators
- Tatiana S Ribeiro, MSc, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113098
- Sponsor's protocol ID
- 488.293
- Status last verified
- May 2019
- First submitted
- 10 Apr 2014
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.
PubMed 28859603
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treadmill Gait Training With Adding Load on Lower Limb of Individuals With Stroke
- ClinicalTrials.gov ID
- NCT02113098
- Acronym / sponsor ID
- 488.293
- Conditions
- Stroke, Gait Disorders, Neurologic
- Keywords
- Stroke, Gait, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Apr 2014 (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.
The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke.
Detailed description
This is a randomized and blinded clinical trial, in which participants are being randomly divided into experimental group and control group, in order to verify the effects of adding load on gait symmetry after stroke. 40 individuals will participate, and the calculation of sample size was performed from the ratio variable symmetry of swing time, based on previous study. Whereas about 15% of individuals could give up to participate in the study during their course (dropout rate), we determined a number of 20 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill, ankle load | Experimental | Other: Treadmill, ankle loadThe experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb |
| Treadmill | Active comparator | Other: TreadmillThe control group (active comparator) will perform gait training on a treadmill |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First episode of stroke (ischemic or hemorrhagic) which determined unilateral hemiparesis
- Time of lesion less one year
- Able to walk independently by 10 feet on flat surface without the use of assistive devices
- Gait speed less than 0.8 m / s
- Ability to understand and obey simple commands
Key exclusion criteria (5 listed)
- Instability of cardiac conditions
- Adverse clinical conditions affecting balance and / or gait
- Pain and / or severe discomfort that impede the realization of the proposed activities
- Decompensation in systemic blood pressure, with the systolic and diastolic values above 200 mmHg and 110 mmHg, respectively, before and / or after training
- Submaximal heart rate above the allowed values during training
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 |
|---|---|---|
| Treadmill, ankle loadThe experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks | Other | Treadmill, ankle load |
| TreadmillThe control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks | Other | Treadmill |
Primary outcome
Ground reaction force, in Newtons
Time frame: Until one year after stroke
Vertical component of ground reaction force, measured using a force platform
Angular displacements of hip, knee and ankle (in degrees)
Time frame: Until one year after stroke
Angular gait variables, measured by a system of movement analysis.
Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)
Time frame: Until one year after stroke
Spatiotemporal gait variable, measured by a system of movement analysis
4 secondary outcomes
speed (meters/second)
Time frame: Until one year after stroke
double support time (in seconds)
Time frame: Until one year after stroke
step length (in meters)
Time frame: Until one year after stroke
stride length (in meters)
Time frame: Until one year after stroke
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 3 Jun 2019.
- Derived from this study: PubMed 28859603E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.
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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.
Tatiana S Ribeiro, MSc principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill, ankle load and Treadmill in people with Stroke and Gait Disorders, Neurologic, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 5 inclusion and 5 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Ground reaction force, in Newtons (time frame: Until one year after stroke). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113098, which also lists 1 linked publication.
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 3 Jun 2019.