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

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Guided Self-rehabilitation Contract Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Guided Self-rehabilitation Contract
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs) After one year of treatment No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary Barthel Activity of Daily Living (ADL) Index One assessment visit every 6 month for 2 years No
Secondary Euro-Qol - 5 dimension (EQ-5D) One assessment visit every 6 month for 2 years No
Secondary Geriatric Depression Scale - 15 One assessment visit every 6 month for 2 years No
Secondary 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 No
Secondary 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 No

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