HemiparesisNEURORESTORENCT02202954
Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke
A study testing Guided Self-rehabilitation Contract in people with Hemiparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In the situation of motor limitations that people often experience after stroke, current health systems cannot provide for the daily amount and duration of high intensity muscle stretch and motor training that would be required over protracted periods to involve muscle and brain plasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Guided Self-rehabilitation Contract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Sep 2017
- 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
- Patient with spastic hemiparesis, following a unique stroke episode over a year before enrollment into the study
- Age ≥ 18
- Barefoot walking possible with no assistive device over 10 m
- Fast barefoot ambulation speed between 0.1 m/sec and 1.3 m/sec
- Mean Modified FRENCHAY Score between 2 and 8/10
- Patient having provided a signed consent to participate in this trial
Who cannot join
- Multiple stroke episodes, clinically of based on brain imaging
- No recent (less than 3 months before enrollment) brain imaging (CT scan or MRI) in case of doubt about multiple stroke episodes
- Concurrent severe condition jeopardizing functional or vital prognosis, or the ability to participate in rehabilitation sessions
- Cognitive, phasic or behavioral condition impeding verbal communication, active participation to a rehabilitation or self-rehabilitation program, or participation in a research study, according to the investigator's judgment
- Person having a tutor or benefiting from a law protection order
- Person not benefiting from French State Health Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke. Efficacy and Cost After One Year Treatment. A Randomized, Controlled, Multicenter, Single Blind Study
In the situation of motor limitations that people often experience after stroke, current health systems cannot provide for the daily amount and duration of high intensity muscle stretch and motor training that would be required over protracted periods to involve muscle and brain plasticity. For patients with sufficient cognitive abilities, Guided Self-rehabilitation Contracts allow implementing stretch and training at high intensity and may result in meaningful functional improvement in chronic stages, as long as discipline persists over at least a year span.
This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as against conventional therapy in the community, for a one year duration in persons with chronic hemiparesis after stroke.
Read the detailed description
This single blind controlled multicentre protocol will compare the evolution after a one-year treatment, either using a Guided Self-rehabilitation Contract or conventional therapy in the community. Patients with chronic stroke-induced hemiparesis (over a year post stroke) will be selected to be randomized between the two groups, Conventional or in Guided Self-rehabilitation Contracts.
In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance:
- Technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month.
- Psychological, binding with the patient on the contract.
The patient agrees to:
- Perform the prescribed daily stretch postures and rapid alternating movements over the long term.
- Document this work in a written diary.
To facilitate such contracts, a manual for guided self-rehabilitation in spastic paresis has been developed and will be provided to patients randomized to that group.
124 patients will be enrolled from 6 centers in France: Creteil, Paris Fernand-Widal, Toulouse, Reims, Saint-Etienne and Bordeaux. The duration of patient participation will be 2 years: 6 months follow-up, 1 year intervention and another 6-month follow-up after the study intervention. Only functional assessments will be used, using in particular ambulation speed for the lower limb and the Modified FRENCHAY Scale for the upper limb.
- Conditions
- Hemiparesis
- Being tested
- Guided Self-rehabilitation Contract
- Keywords
- Stroke, Muscle Spasticity, Rehabilitation
- Medical subject headings
- Paresis, Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-rehabilitation ContractOther
In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract.
The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary.
| Study group | Role | What they receive |
|---|---|---|
| Guided Self-rehabilitation Contract | Active comparator | In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract.
The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary. Receives: Other: Guided Self-rehabilitation Contract |
| Conventional rehabilitation | No intervention | conventional therapy in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)
- Fast 10-meter barefoot ambulation speed with no assistive device
- Active upper limb function using the Modified FRENCHAY scale (10 everyday life activities performed live in front of the investigator and videotaped - videos reviewed later by a blinded investigator).
Measured: After one year of treatment
Secondary outcomes (8)
Speed, step length and cadence over 10 meters at comfortable speed, barefoot and with shoes, with no assistive device
Measured: One assessment visit every 6 month for 2 years
Speed, step length, cadence and physiological cost index over 2 minutes at maximal speed, with shoes
Measured: One assessment visit every 6 month for 2 years
Disability Assessment Scale: interview between patient and investigator, assessing the level of disability in 4 domains (dressing, cosmesis, hygiene and pain)
Measured: One assessment visit every 6 month for 2 years
Barthel Activity of Daily Living (ADL) Index
Measured: One assessment visit every 6 month for 2 years
Euro-Qol - 5 dimension (EQ-5D)
European Quality of Life Scale
Measured: One assessment visit every 6 month for 2 years
Geriatric Depression Scale - 15
Measured: One assessment visit every 6 month for 2 years
Questionnaire to the patient (or caregiver) evaluating monthly frequency of physical therapy sessions and amount of home aid during the whole study period, that will serve as basis for a cost evaluation from the point of view of medical insurance.
Measured: One assessment visit every 6 month for 2 years
Estimation of the total cost of care, including medical costs, social expenses, amount of social benefits, from the point of view of the medical insurance and of the state, to include all payors.
Measured: One assessment visit every 6 month for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2017
- Study completionSep 2017 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel GRACIES, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202954
- Sponsor's protocol ID
- P100114
- Other IDs
- 2012-A00348-35
- Acronym
- NEURORESTORE
- Status last verified
- Jun 2017
- First submitted
- 25 Jul 2014
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.
PubMed 30871480
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke. Efficacy and Cost After One Year Treatment. A Randomized, Controlled, Multicenter, Single Blind Study
- ClinicalTrials.gov ID
- NCT02202954
- Acronym / sponsor ID
- NEURORESTORE / P100114
- Conditions
- Hemiparesis
- Keywords
- Stroke, Muscle Spasticity, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 29 Jul 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.
In the situation of motor limitations that people often experience after stroke, current health systems cannot provide for the daily amount and duration of high intensity muscle stretch and motor training that would be required over protracted periods to involve muscle and brain plasticity. For patients with sufficient cognitive abilities, Guided Self-rehabilitation Contracts allow implementing stretch and training at high intensity and may result in meaningful functional improvement in chronic stages, as long as discipline persists over at least a year span.
This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as against conventional therapy in the community, for a one year duration in persons with chronic hemiparesis after stroke.
Detailed description
This single blind controlled multicentre protocol will compare the evolution after a one-year treatment, either using a Guided Self-rehabilitation Contract or conventional therapy in the community. Patients with chronic stroke-induced hemiparesis (over a year post stroke) will be selected to be randomized between the two groups, Conventional or in Guided Self-rehabilitation Contracts.
In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance:
- Technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month.
- Psychological, binding with the patient on the contract.
The patient agrees to:
- Perform the prescribed daily stretch postures and rapid alternating movements over the long term.
- Document this work in a written diary.
To facilitate such contracts, a manual for guided self-rehabilitation in spastic paresis has been developed and will be provided to patients randomized to that group.
124 patients will be enrolled from 6 centers in France: Creteil, Paris Fernand-Widal, Toulouse, Reims, Saint-Etienne and Bordeaux. The duration of patient participation will be 2 years: 6 months follow-up, 1 year intervention and another 6-month follow-up after the study intervention. Only functional assessments will be used, using in particular ambulation speed for the lower limb and the Modified FRENCHAY Scale for the upper limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Self-rehabilitation Contract | Active comparator | Other: Guided Self-rehabilitation ContractIn Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract. The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary. |
| Conventional rehabilitation | No intervention | –conventional therapy in the community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with spastic hemiparesis, following a unique stroke episode over a year before enrollment into the study
- Age ≥ 18
- Barefoot walking possible with no assistive device over 10 m
- Fast barefoot ambulation speed between 0.1 m/sec and 1.3 m/sec
- Mean Modified FRENCHAY Score between 2 and 8/10
Key exclusion criteria (6 listed)
- Multiple stroke episodes, clinically of based on brain imaging
- No recent (less than 3 months before enrollment) brain imaging (CT scan or MRI) in case of doubt about multiple stroke episodes
- Concurrent severe condition jeopardizing functional or vital prognosis, or the ability to participate in rehabilitation sessions
- Cognitive, phasic or behavioral condition impeding verbal communication, active participation to a rehabilitation or self-rehabilitation program, or participation in a research study, according to the investigator's judgment
- Person having a tutor or benefiting from a law protection order
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 |
|---|---|---|
| Guided Self-rehabilitation ContractIn Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract. The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary. | Other | Guided Self-rehabilitation Contract |
Primary outcome
Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)
Time frame: After one year of treatment
1. Fast 10-meter barefoot ambulation speed with no assistive device 2. Active upper limb function using the Modified FRENCHAY scale (10 everyday life activities performed live in front of the investigator and videotaped - videos reviewed later by a blinded investigator).
8 secondary outcomes
Speed, step length and cadence over 10 meters at comfortable speed, barefoot and with shoes, with no assistive device
Time frame: One assessment visit every 6 month for 2 years
Speed, step length, cadence and physiological cost index over 2 minutes at maximal speed, with shoes
Time frame: One assessment visit every 6 month for 2 years
Disability Assessment Scale: interview between patient and investigator, assessing the level of disability in 4 domains (dressing, cosmesis, hygiene and pain)
Time frame: One assessment visit every 6 month for 2 years
Barthel Activity of Daily Living (ADL) Index
Time frame: One assessment visit every 6 month for 2 years
Euro-Qol - 5 dimension (EQ-5D)
Time frame: One assessment visit every 6 month for 2 years
Geriatric Depression Scale - 15
Time frame: One assessment visit every 6 month for 2 years
Questionnaire to the patient (or caregiver) evaluating monthly frequency of physical therapy sessions and amount of home aid during the whole study period, that will serve as basis for a cost evaluation from the point of view of medical insurance.
Time frame: One assessment visit every 6 month for 2 years
Estimation of the total cost of care, including medical costs, social expenses, amount of social benefits, from the point of view of the medical insurance and of the state, to include all payors.
Time frame: One assessment visit every 6 month for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Derived from this study: PubMed 30871480Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.
- Related InfoLink provided by the sponsor.
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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.
Jean-Michel GRACIES, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-rehabilitation Contract in people with Hemiparesis, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Jun 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?
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?
Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs) (time frame: After one year of treatment). 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 NCT02202954, 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 Jun 2017.