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Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke (NEURORESTORE)

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ClinicalTrials.gov Identifier: NCT02202954
Recruitment Status : Active, not recruiting
First Posted : July 29, 2014
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Hemiparesis Other: Guided Self-rehabilitation Contract Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2014
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Guided Self-rehabilitation Contract

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.

Other: Guided Self-rehabilitation Contract

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.


No Intervention: Conventional rehabilitation
conventional therapy in the community



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Barthel Activity of Daily Living (ADL) Index [ Time Frame: One assessment visit every 6 month for 2 years ]
  5. Euro-Qol - 5 dimension (EQ-5D) [ Time Frame: One assessment visit every 6 month for 2 years ]
    European Quality of Life Scale

  6. Geriatric Depression Scale - 15 [ Time Frame: One assessment visit every 6 month for 2 years ]
  7. 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 ]
  8. 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 ]

Other Outcome Measures:
  1. Evaluation by the occupational therapist of home adaptation and the functioning at home [ Time Frame: One assessment visit every 6 month for 2 years ]
    An ancillary study on the 44 patients in the Paris area

  2. Evaluation by a clinical psychologist of coping with each type of care (guided self-rehabilitation or conventional), of the required psychological resources and the potential need for psychological follow-up. [ Time Frame: One assessment visit every 6 month for 2 years ]
    An ancillary study on the 44 patients in the Paris area.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202954


Locations
France
Henri Mondor Hospital
Créteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Michel GRACIES, MD, PhD Assistance Publique - Hôpitaux de Paris

Additional Information:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02202954     History of Changes
Other Study ID Numbers: P100114
2012-A00348-35 ( Other Identifier: ID RCB )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Stroke
Muscle Spasticity
Rehabilitation

Additional relevant MeSH terms:
Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms