Evaluation of the effect of repeated injections of botulinum toxin into the lower limb.

Phase 1

• Conditions: Patients with spastic brain lesions. Children with cerebral palsy (CP) and in the hemiplegic adult.; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-002499-42-BE
• Lead Sponsor: Cliniques Universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-03
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. adults (> 18 years)
2.hemiparesis after first stroke, delay after stroke> 6 months
3. limb-gait spasticity
4.ability to perform treadmill walking tests, indication of focal chemical denervation
Sub-study :
1. old: > 4 and <18 years,
2.cerebral palsy (spastic hemiplegia, diplegia or quadriplegia)
3. Gross Motor Function Classification System (GMFCS) <4.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

1. aphasia or major cognitive impairment limiting functional evaluation
2. neurological or orthopedic problem interfering with the function of the lower limb studied
3. injections of botulinum toxin in the lower limb less than 5 months old
4.contraindication to botulinum toxin (neuromuscular disease under -cente)
5.contraindication to performing an MRI.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. Demonstrate that repeated injections of high-dose botulinum toxin significantly improve the functional functioning of hemiplegic spastic adult patients compared to single-dose, moderate-dose injections.<br>2. Demonstrate the validity of the low-cost KI-Gait walk analysis system, based on the Kinect infrared camera device, in children with cerebral palsy (CP) and in hemiplegic adults.<br><br><br><br><br><br><br><br><br>Demonstrate that repeated injections of high-dose botulinum toxin significantly improve the functional functioning of hemiplegic spastic patients compared to single-dose, moderate-dose injections<br><br><br><br><br>;Secondary Objective: Not applicable;Primary end point(s): Functional assessments will be based on the WHO International Classification of Functioning, Disability and Health.<br>Assessment by clinical exam and by NMR;Timepoint(s) of evaluation of this end point: The evaluations will be done at Mont 1, month 3 and month 6.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Impairments will be assessed using clinical examination (evaluation of range of motion by manual goniometry, spasticity by modified Ashworth and Tardieu scales, evaluation of motor control by the Fugl-Meyer test), by functional data (10-meter fast-running speed, modified 6-minute test22, timed rise and fall test, 23 Timed Up and Go Test24) and AQM. Activity limitations will be assessed using the ABILOCO25 questionnaire. The quality of life of patients will be evaluated by the French version of Short-Form Health Survey SF-36.;Timepoint(s) of evaluation of this end point: The evaluations will be done at Mont 1, month 3, month 4, month 6 and month 7.