HemiplegiaHEMIMARCHENCT00658710
Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients
A study testing physical therapy sessions in people with Hemiplegia, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial summary
The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- physical therapy sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2008to Dec 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged 18 to 75 years, with a first ischemic or hemorrhagic stroke at least six months ago and no longer than two years ago, without subsequent stroke. It must have caused initially complete hemiplegia of the right or left hemibody, but they must be able of walk alone with or without technical assistance over a distance of at least 10 meters They must be able change direction too.
- Finally, they must have a Functional Ambulation Classification (FAC) score between 4 and 6 during the inclusion.
Who cannot join
- We will exclude patients with a neurological history other than a stroke, a psychiatric illness, or an associated debilitating disease.
- They must not have an associated cerebella syndrome or a clinical brainstem attack.
- We will refuse patients who are pregnant, who have not signed the written consent, and who aren't entitled to a social security scheme.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Régional de Réeducation et de Réadaptation Fonctionnelle
Angers, 49103
Groupe hospitalier Pellegrin CHU Bordeaux
Bordeaux, 33076
Hôpital J. Rebeyrol
Limoges, 87042
Institut Régional de médecine physique et de Réadaptation
Nancy, 54042
CHU de St Etienne
Saint-Etienne, 42055
About this study
The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.
Read the detailed description
The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months. This will permit us 1) to assess the efficacy of continuing physical therapy sessions during the chronic phase of post-stroke hemiplegia, 2) to investigate whether the effects of physical therapy in these patients gradually decreases during the period of six months to two years post-stroke, and 3) to model the relationship between standard measures of gait performance (speed, endurance, balance, use of technical aids…) with other multidimensional covariates: social and environmental factors (type of housing, presence of a third person,…), cognitive factors (cognitive disorders associated) and thymic factors (anxiety, depression) and 4) to assess the costs associated with the physical therapy care of chronic-phase stroke patients .
- Conditions
- Hemiplegia
- Being tested
- physical therapy sessions
- Keywords
- hemiplegia, stroke, TRIDENT
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy sessionsBehavioural
two physical therapy sessions per week for two months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients who continue physical therapy sessions during two months. Receives: Behavioral: physical therapy sessions |
| 2 | No intervention | patients who stop physical therapy sessions during two months |
What is being measured
The primary outcome is the main question the study is designed to answer.
the average number of steps per day recorded over 3 days in an outpatient setting
Measured: day 3 and then 6 months later
Secondary outcomes (2)
the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score)
Measured: day 0 and then day 55
for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pascal Giraux, MD, Principal investigator, CHU ST Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658710
- Sponsor's protocol ID
- 0701040
- Other IDs
- 2007-A00747-46
- Acronym
- HEMIMARCHE
- Status last verified
- Nov 2013
- First submitted
- 11 Apr 2008
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients
- ClinicalTrials.gov ID
- NCT00658710
- Acronym / sponsor ID
- HEMIMARCHE / 0701040
- Conditions
- Hemiplegia
- Keywords
- hemiplegia, stroke, TRIDENT
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Apr 2008 (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 multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.
Detailed description
The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months. This will permit us 1) to assess the efficacy of continuing physical therapy sessions during the chronic phase of post-stroke hemiplegia, 2) to investigate whether the effects of physical therapy in these patients gradually decreases during the period of six months to two years post-stroke, and 3) to model the relationship between standard measures of gait performance (speed, endurance, balance, use of technical aids…) with other multidimensional covariates: social and environmental factors (type of housing, presence of a third person,…), cognitive factors (cognitive disorders associated) and thymic factors (anxiety, depression) and 4) to assess the costs associated with the physical therapy care of chronic-phase stroke patients .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: physical therapy sessionspatients who continue physical therapy sessions during two months. |
| 2 | No intervention | –patients who stop physical therapy sessions during two months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be aged 18 to 75 years, with a first ischemic or hemorrhagic stroke at least six months ago and no longer than two years ago, without subsequent stroke. It must have caused initially complete hemiplegia of the right or left hemibody, but they must be able of walk alone with or without technical assistance over a distance of at least 10 meters They must be able change direction too.
- Finally, they must have a Functional Ambulation Classification (FAC) score between 4 and 6 during the inclusion.
Key exclusion criteria (3 listed)
- We will exclude patients with a neurological history other than a stroke, a psychiatric illness, or an associated debilitating disease.
- They must not have an associated cerebella syndrome or a clinical brainstem attack.
- We will refuse patients who are pregnant, who have not signed the written consent, and who aren't entitled to a social security scheme.
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 |
|---|---|---|
| physical therapy sessionstwo physical therapy sessions per week for two months | Behavioural | 1 |
Primary outcome
the average number of steps per day recorded over 3 days in an outpatient setting
Time frame: day 3 and then 6 months later
2 secondary outcomes
the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score)
Time frame: day 0 and then day 55
for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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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.
Pascal Giraux, MD principal investigator
CHU ST Etienne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy sessions in people with Hemiplegia, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites 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: stopped early, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 was stopped early. Results are not available in the source record.
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?
the average number of steps per day recorded over 3 days in an outpatient setting (time frame: day 3 and then 6 months later). 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 7 Nov 2013.