StrokeHemislopeNCT02333032
Effects of a Positive Slope Treadmill Training in Individuals After Stroke. (Hemislope)
A study testing Inclined treadmill training in people with Stroke, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The main objective of this study is to determine if a single session of treadmill training with a positive slope improves the kinematic parameters of the hip, knee and ankle on the paretic lower limb. Secondarily we will quantify the efficiency of a such training on kinetic and functional parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Inclined treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic patient
- capacity to walk during 20 minutes without technical assistance
Who cannot join
- patient with bilateral brain lesions
- previous orthopedic surgery
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Biomechanical and Functional Effects of a Positive Slope Treadmill Training in Individuals After Stroke.
The main objective of this study is to determine if a single session of treadmill training with a positive slope improves the kinematic parameters of the hip, knee and ankle on the paretic lower limb.
Secondarily we will quantify the efficiency of a such training on kinetic and functional parameters.
Read the detailed description
comparison between patients having a single session of treadmill training with slope and those having a single session of treadmill training with no slope
- Conditions
- Stroke
- Being tested
- Inclined treadmill training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclined treadmill trainingOther
| Study group | Role | What they receive |
|---|---|---|
| hemiplegic patient | Experimental | Not described Receives: Other: Inclined treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematic gait parameters
angles quantification of lower limbs joints
Measured: One year
cinetic gait parameters
moments and joints power quantification in the lower limb
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- randomised controlled study experimental group : training with slope N=15 control group training with no slope N=15
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333032
- Sponsor's protocol ID
- 2014-A01500-47
- Acronym
- Hemislope
- Status last verified
- Mar 2017
- First submitted
- 24 Dec 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biomechanical and Functional Effects of a Positive Slope Treadmill Training in Individuals After Stroke.
- ClinicalTrials.gov ID
- NCT02333032
- Acronym / sponsor ID
- Hemislope / 2014-A01500-47
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Jan 2015 (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 main objective of this study is to determine if a single session of treadmill training with a positive slope improves the kinematic parameters of the hip, knee and ankle on the paretic lower limb.
Secondarily we will quantify the efficiency of a such training on kinetic and functional parameters.
Detailed description
comparison between patients having a single session of treadmill training with slope and those having a single session of treadmill training with no slope
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- randomised controlled study experimental group : training with slope N=15 control group training with no slope N=15
| Arm | Type | Receives |
|---|---|---|
| hemiplegic patient | Experimental | Other: Inclined treadmill training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemiplegic patient
- capacity to walk during 20 minutes without technical assistance
Key exclusion criteria (3 listed)
- patient with bilateral brain lesions
- previous orthopedic surgery
- pregnant woman
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 |
|---|---|---|
| Inclined treadmill training | Other | hemiplegic patient |
Primary outcome
kinematic gait parameters
Time frame: One year
angles quantification of lower limbs joints
cinetic gait parameters
Time frame: one year
moments and joints power quantification in the lower limb
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 22 Mar 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclined treadmill training in people with Stroke, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 2 inclusion and 3 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 22 Mar 2017. 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 France. 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 gait parameters (time frame: One year). The study lists 2 primary outcomes in all. 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 22 Mar 2017.