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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

September 14, 2016
October 26, 2016
January 17, 2018
November 20, 2017
December 2020   (Final data collection date for primary outcome measure)
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.
Assessment of Goal Attainment Scaling (GAS). [ Time Frame: 6 months ]
Complete list of historical versions of study NCT02944929 on ClinicalTrials.gov Archive Site
  • Assessment of the Functional Independence Measure (FIM) [ Time Frame: 6 months ]
  • Assessment of Hemispatial neglect [ Time Frame: 6 months ]
  • Quality of life questionnaire [ Time Frame: 6 months ]
  • Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment) [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
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
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Spastic Hemiparesis
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.
  • Experimental: Self-rehabilitation program
    Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy)
    Intervention: Other: Self-rehabilitation program
  • No Intervention: Control arm
    Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
Same as current
March 2021
December 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
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
France
 
 
NCT02944929
P150907
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Nicolas Roche, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP