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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)

Primary Purpose

Spastic Hemiparesis

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Self-rehabilitation program

About this trial

This is an interventional treatment trial for Spastic Hemiparesis focused on measuring Spastic hemiparesis, Stroke, Self-rehabilitation, Botulinum Toxin Injections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion.
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.

Exclusion Criteria:

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.

Sites / Locations

Hôpital Raymond PoincaréRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-rehabilitation program

Control arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assessment of the Functional Independence Measure (FIM)

Assessment of Hemispatial neglect

Quality of life questionnaire

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

Full Information

NCT ID

NCT02944929

First Posted

September 14, 2016

Last Updated

March 25, 2020

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02944929

Brief Title

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

Acronym

ADJU-TOX

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

January 3, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spastic Hemiparesis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Self-rehabilitation program

Arm Type

Experimental

Arm Description

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

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Self-rehabilitation program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Assessment of Goal Attainment Scaling (GAS).

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Assessment of the Functional Independence Measure (FIM)

Time Frame

6 months

Title

Assessment of Hemispatial neglect

Time Frame

6 months

Title

Quality of life questionnaire

Time Frame

6 months

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion. 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas Roche, MD

Phone

+ 33(1) 47 10 54 09

roche.nicolas@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Bensmail Djamel, MD

Phone

+ 33(1) 47 10 70 60

djamel.bensmail@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Roche, MD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Raymond Poincaré

City

Garches

ZIP/Postal Code

92380

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

30166290

Citation

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.

Results Reference

derived

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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

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