HemiparesisNCT01106755
Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)
A study testing gait training on ground level using BWS and gait training on ground level using BWS associated to FES in people with Hemiparesis and Stroke, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The aim of this study was to investigate the effects of gait training on ground level, combining BWS and FES in people following chronic stroke. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hemiparesis, Stroke
- What is being tested?
- gait training on ground level using BWS and gait training on ground level using BWS associated to FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Dec 2009
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elapsed time since stroke longer than 6 months
- Spasticity classified under level 3 according to the Modified Ashworth Scale
- The ability to walk classified at levels 2, 3 or 4 according to the Functional Ambulation Category
Who cannot join
- Heart failure, angina pectoris, arrhythmias and other cardiovascular diseases
- Severe lung disease
- Orthopedic disorders
- Cognitive deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ground-level Gait Training Combining Body Weight Support and Functional Electrical Stimulation in People Following Chronic Stroke
The aim of this study was to investigate the effects of gait training on ground level, combining BWS and FES in people following chronic stroke.
Read the detailed description
The body weight support system (BWS) associated to a treadmill as well as to a functional electrical stimulation (FES) of the common peroneal nerve, has been proposed as a strategy for gait training in people following stroke. Moreover, it has also considered that the ground level is the most common locomotion surface, and that there is little information about the effects of gait training, on this kind of surface, in people with hemiparesis.
- Conditions
- Hemiparesis, Stroke
- Being tested
- gait training on ground level using BWS, gait training on ground level using BWS associated to FES
- Keywords
- kinematic, hemiparesis, gait, Body weight support, Functional electrical stimulation
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait training on ground level using BWSDevice
An A1-B-A2 system was applied in which A1 and A2 corresponded to gait training on ground level using Body Weight Support (BWS). Each training phase was performed during 45 minutes, three times a week, for six weeks.
gait training on ground level using BWS associated to FESDevice
An A1-B-A2 system was applied in which B corresponded to the training associated to Functional Electrical Stimulation. Each training phase was performed during 45 minutes, three times a week, for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| hemiparetic gait | Experimental | gait training on ground level Receives: Device: gait training on ground level using BWS; Device: gait training on ground level using BWS associated to FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematic evaluation
Participants were assessed walking freely at a comfortable self-selected speed before and after each training phase. The analyzed variables were: mean walking speed of locomotion; step length; stride length, speed and duration; initial and final double support duration; single-limb support duration; swing period; range of motion (ROM), maximum and minimum angles of foot, leg, thigh, and trunk segments of both paretic and nonparetic limbs.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startSep 2008
- Primary completionMay 2009
- Study completionDec 2009
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 HemiparesisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Tania F Salvini, PhD, Principal investigator, Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106755
- Sponsor's protocol ID
- UFSCar-240781
- Status last verified
- Aug 2008
- First submitted
- 19 Apr 2010
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prado-Medeiros CL, Sousa CO, Souza AS, Soares MR, Barela AM, Salvini TF. Effects of the addition of functional electrical stimulation to ground level gait training with body weight support after chronic stroke. Rev Bras Fisioter. 2011 Nov-Dec;15(6):436-44. doi: 10.1590/s1413-35552011005000030. Epub 2011 Oct 27.
PubMed 22031271
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ground-level Gait Training Combining Body Weight Support and Functional Electrical Stimulation in People Following Chronic Stroke
- ClinicalTrials.gov ID
- NCT01106755
- Acronym / sponsor ID
- UFSCar-240781
- Conditions
- Hemiparesis, Stroke
- Keywords
- kinematic, hemiparesis, gait, Body weight support, Functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Apr 2010 (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 aim of this study was to investigate the effects of gait training on ground level, combining BWS and FES in people following chronic stroke.
Detailed description
The body weight support system (BWS) associated to a treadmill as well as to a functional electrical stimulation (FES) of the common peroneal nerve, has been proposed as a strategy for gait training in people following stroke. Moreover, it has also considered that the ground level is the most common locomotion surface, and that there is little information about the effects of gait training, on this kind of surface, in people with hemiparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemiparetic gait | Experimental | Device: gait training on ground level using BWS, Device: gait training on ground level using BWS associated to FESgait training on ground level |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elapsed time since stroke longer than 6 months
- Spasticity classified under level 3 according to the Modified Ashworth Scale
- The ability to walk classified at levels 2, 3 or 4 according to the Functional Ambulation Category
Key exclusion criteria (4 listed)
- Heart failure, angina pectoris, arrhythmias and other cardiovascular diseases
- Severe lung disease
- Orthopedic disorders
- Cognitive deficits
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 |
|---|---|---|
| gait training on ground level using BWSAn A1-B-A2 system was applied in which A1 and A2 corresponded to gait training on ground level using Body Weight Support (BWS). Each training phase was performed during 45 minutes, three times a week, for six weeks. | Device | hemiparetic gait |
| gait training on ground level using BWS associated to FESAn A1-B-A2 system was applied in which B corresponded to the training associated to Functional Electrical Stimulation. Each training phase was performed during 45 minutes, three times a week, for six weeks. | Device | hemiparetic gait |
Primary outcome
kinematic evaluation
Time frame: 4 months
Participants were assessed walking freely at a comfortable self-selected speed before and after each training phase. The analyzed variables were: mean walking speed of locomotion; step length; stride length, speed and duration; initial and final double support duration; single-limb support duration; swing period; range of motion (ROM), maximum and minimum angles of foot, leg, thigh, and trunk segments of both paretic and nonparetic limbs.
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 20 Apr 2010.
- Derived from this study: PubMed 22031271Prado-Medeiros CL, Sousa CO, Souza AS, Soares MR, Barela AM, Salvini TF. Effects of the addition of functional electrical stimulation to ground level gait training with body weight support after chronic stroke. Rev Bras Fisioter. 2011 Nov-Dec;15(6):436-44. doi: 10.1590/s1413-35552011005000030. Epub 2011 Oct 27.
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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.
Tania F Salvini, PhD principal investigator
Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gait training on ground level using BWS and gait training on ground level using BWS associated to FES in people with Hemiparesis and Stroke, run by Universidade Federal de Sao Carlos 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 3 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 20 Apr 2010. 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?
kinematic evaluation (time frame: 4 months). 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 NCT01106755, 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 20 Apr 2010.