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

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.

Study Overview

• Status: Unknown
• Conditions: Hemiparesis
• Intervention / Treatment: Other: Guided Self-rehabilitation Contract

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
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94010
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After one year of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speed, step length and cadence over 10 meters at comfortable speed, barefoot and with shoes, with no assistive device		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		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)		One assessment visit every 6 month for 2 years
Barthel Activity of Daily Living (ADL) Index		One assessment visit every 6 month for 2 years
Euro-Qol - 5 dimension (EQ-5D)	European Quality of Life Scale	One assessment visit every 6 month for 2 years
Geriatric Depression Scale - 15		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.		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.		One assessment visit every 6 month for 2 years

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: July 25, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 29, 2014

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Muscle Spasticity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: P100114; 2012-A00348-35 (Other Identifier: ID RCB)