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

NCT02202954 | Unknown DMC

• 2 other identifiers: P1001142012-A00348-35
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis

Keywords

Stroke; Muscle Spasticity; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs)

  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).

  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

  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)

  One assessment visit every 6 month for 2 years

Other Outcomes (2)

• Evaluation by the occupational therapist of home adaptation and the functioning at home

  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.

  One assessment visit every 6 month for 2 years

Study Arms (2)

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.

Other: Guided Self-rehabilitation Contract

Conventional rehabilitation

NO INTERVENTION

conventional therapy in the community

Interventions

Guided Self-rehabilitation Contract OTHER

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.

Guided Self-rehabilitation Contract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Publications (1)

• 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.

  PMID: 30871480 DERIVED

MeSH Terms

Conditions

Paresis; Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Jean-Michel GRACIES, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

FR (1)