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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03714269
Other study ID # 18CH121
Secondary ID ANSM
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2018
Est. completion date November 28, 2018

Study information

Verified date October 2018
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date November 28, 2018
Est. primary completion date November 28, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 14 Years
Eligibility Inclusion Criteria:

- Children with cerebral palsy of the spastic type

- Children with a maximum dorsal ankle flexion amplitude limitation of less than 10°.

Exclusion Criteria:

- Children who have undergone surgery on the lower limbs.

- Children with a botulinum toxin injection and/or a series of elongation casts for less than three months.

- Children with ongoing analgesic treatment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
measurement evaluated with an isokinetic dynamometer
measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer
measurement evaluated with an 2D ultrasound
simultaneous recording of force torque, joint angle and myotendinous junction displacement in 2D ultrasound during 5 passive mobilization cycles of ankle flexion-extension at very low speed recording of static images in 2D ultrasound representing the proximal insertion of the gastrocnemius muscle in the internal condyle of the femur, the myotendinous junction.
assessment of the level of discomfort
visual analogue scale (0 = no discomfort and 10 = maximal discomfort)

Locations

Country Name City State
France CHU de Saint Etienne Saint Etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion baseline
Secondary Maximum dorsal flexion angle of ankle, knee in maximum extension position at 5 minutes
Secondary slope of the force-displacement torque curve myotendinous junction of the Sural Triceps in the articular sector -25° plantar flexion/maximum dorsal flexion at 5 minutes
Secondary lengths of the musculotendinous unit of the Triceps Sural muscle, the muscular body of the gastrocnemius muscle and the Achilles tendon in cm measured at rest, knee in maximum extension position, ankle angle in neutral plantar/dorsal flexion position. at 5 minutes
Secondary visual analogue scale of discomfort 0 = not discomfort and 10 = maximal discomfort at 5 minutes
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