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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 (ADJU-TOX)

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ClinicalTrials.gov Identifier: NCT02944929
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Spastic Hemiparesis Other: Self-rehabilitation program Phase 4

Detailed Description:

Stroke affects 150 000 persons in France each year. Most patients have activity limitations because of the resulting motor deficit and spasticity. Autonomy in activities of daily living is reduced.

The principal treatment for focal spasticity is currently intramuscular botulinum toxin injection (BTI).

BTI is classically combined with only 2 to 3 sessions of out-patient physiotherapy per week. This is mainly because of a lack of out-patient therapists. However, this amount of therapy is insufficient and does not follow current literature which shows that the intensity of physiotherapy affects the recovery of impairment and activity. This gap in our health system could be filled by a self-rehabilitation program in addition to physiotherapy.

Recent studies have shown that self-rehabilitation following BTI could significantly improve activity limitation (Roche et al, 2014 ; Sun et al 2010).

The addition of a self-rehabilitation program to BTI and usual out-patient physiotherapy could thus increase the effects of BTI on impairment and activity limitation in patients with spastic hemiparesis following stroke.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity (Repeated Botulinum Toxin Injections and Physiotherapy) on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Self-rehabilitation program
Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy)
Other: Self-rehabilitation program
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.

No Intervention: Control arm
Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program



Primary Outcome Measures :
  1. Assessment of Goal Attainment Scaling (GAS). [ Time Frame: 6 months ]
    The percentage of patients who attain their Primary Treatment Goal determined using Goal Attainment Scaling (GAS) at each visits and in both groups.


Secondary Outcome Measures :
  1. Assessment of the Functional Independence Measure (FIM) [ Time Frame: 6 months ]
  2. Assessment of Hemispatial neglect [ Time Frame: 6 months ]
  3. Quality of life questionnaire [ Time Frame: 6 months ]
  4. Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females aged between 18 to 75 years.
  2. Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained.
  3. Single stroke having occurred more than 6 months before (previous TIA is accepted).
  4. Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) < 3).
  5. Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion.
  6. Affiliation to the French social security regime or a similar regime.
  7. Patient (or the legal guardian if under guardian adult patient) has signed the informed consent form.

Exclusion Criteria:

  1. 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.
  2. Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator.
  3. Un-controlled progressive pathology.
  4. Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study.
  5. Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.).
  6. Surgery to the treated limb less than 6 months previously.
  7. Pregnant woman.

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): NCT02944929


Contacts
Contact: Nicolas Roche, MD + 33(1) 47 10 54 09 roche.nicolas@aphp.fr
Contact: Bensmail Djamel, MD + 33(1) 47 10 70 60 djamel.bensmail@aphp.fr

Locations
France
Hôpital Raymond Poincaré Recruiting
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nicolas Roche, MD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02944929     History of Changes
Other Study ID Numbers: P150907
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Spastic hemiparesis
Stroke
Self-rehabilitation
Botulinum Toxin Injections

Additional relevant MeSH terms:
Muscle Spasticity
Paresis
Hemiplegia
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paralysis
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs