The Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke

NCT02944929 | Unknown Phase 3

• 1 other identifier: P150907
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.

Conditions

Spastic Hemiparesis

Keywords

Spastic hemiparesis; Stroke; Self-rehabilitation; Botulinum Toxin Injections

Outcome Measures

Primary Outcomes (1)

• Assessment of Goal Attainment Scaling (GAS).

  The percentage of patients who attain their Primary Treatment Goal determined using Goal Attainment Scaling (GAS) at each visits and in both groups.

  6 months

Secondary Outcomes (4)

• Assessment of the Functional Independence Measure (FIM)

  6 months

• Assessment of Hemispatial neglect

  6 months

• Quality of life questionnaire

  6 months

• Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment)

  6 months

Study Arms (2)

Self-rehabilitation program

EXPERIMENTAL

Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy)

Other: Self-rehabilitation program

Control arm

NO INTERVENTION

Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program

Interventions

Self-rehabilitation program OTHER

The self-rehabilitation program will be based on muscle stretching, strengthening and task oriented exercises. For each patient, two exercises will be selected by the therapist for each of these 3 domains (total of 6 exercises) from a list of 50 exercises.

Self-rehabilitation program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged between 18 to 75 years.
• Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained.
• Single stroke having occurred more than 6 months before (previous TIA is accepted).
• Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) \< 3).
• Affiliation to the French social security regime or a similar regime.
• Patient (or the legal guardian if under guardian adult patient) has signed the informed consent form.

You may not qualify if:

• Patients who are unwilling to participate in the study. For the one under guardianship, the refusal of the patient will be the final decision even if the guardian is willing to participate.
• Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator.
• Un-controlled progressive pathology.
• Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study.
• Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.).
• Surgery to the treated limb less than 6 months previously.
• Pregnant woman.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, 92380, France

RECRUITING

Related Publications (1)

• Bonnyaud C, Gallien P, Decavel P, Marque P, Aymard C, Pellas F, Isner ME, Boyer FC, Muller F, Daviet JC, Dehail P, Perrouin-Verbe B, Bayle N, Coudeyre E, Perennou D, Laffont I, Ropers J, Domingo-Saidji NY, Bensmail D, Roche N; ADJU-TOX Study Group. Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study. BMJ Open. 2018 Aug 30;8(8):e020915. doi: 10.1136/bmjopen-2017-020915.

  PMID: 30166290 DERIVED

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

Paralysis; 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

Study Officials

• Nicolas Roche, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Roche, MD

CONTACT

+ 33(1) 47 10 54 09; roche.nicolas@aphp.fr

Bensmail Djamel, MD

CONTACT

+ 33(1) 47 10 70 60; djamel.bensmail@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: October 26, 2016
• Study Start: January 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: January 3, 2021
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

FR (1)