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

Evaluation of the effect of repeated injections of high doses of botulinum toxin into the lower limb of spastic brain lesions on functional and biomechanical parameters of walking

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002499-42-BE

Enrollment

330

Registered

2018-07-03

Start date

2018-08-29

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with spastic brain lesions. Children with cerebral palsy (CP) and in the hemiplegic adult.

Interventions

Trade Name: Xeomeen Product Name: Xeomeen Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Xeomeen Other descriptive name: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), F

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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. 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. 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 ;Secondary Objective: Not applicable;Primary end point(s): Functional assessments will be based on the WHO International Classification of Functioning, Disability and Health. 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.	—

Measure

Time frame

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. 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. 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 ;Secondary Objective: Not applicable;Primary end point(s): Functional assessments will be based on the WHO International Classification of Functioning, Disability and Health. 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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Belgium

Contacts

Public ContactGaetan Stoquart

Cliniques Universitaires Saint-Luc

gaetan.stoquart@uclouvain.be003227641649

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026