Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy

Cerebral Palsy, Spastic Clinical Trial

Official title:

Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287673
• Other study ID #: IRR-2015-1
• Status: Completed
• Phase: N/A
• Start date: December 20, 2016
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• Source: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gait abnormalities, which occur in Cerebral Palsy (CP), are characterized usually by a toe-to-floor or a plantar-to-floor initial contact (equinus gait), followed by an early braking of the tibia's forward progression (during ankle dorsiflexion). This causes consequently a trunk deceleration. Moreover, children with CP have difficulties to stabilize the trunk and the head in the space, and that could have impact on gait. If equinus gait is often attributed to the triceps surae spasticity, recent works suggest rather that this early braking of the dorsiflexion could be a motor adaptation to axial postural control difficulties. This thesis project aims firstly to attest that locomotor disorders are related to these difficulties in the stabilization of the axial body segments in children with CP and, secondly, to show that improving the trunk and head postural control with a specific rehabilitation protocol could reduce the early braking of the dorsiflexion and, consequently, the gait abnormalities observed in CP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 30, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Gross Motor Function Classification System I or II

• no or minimal contracture of the triceps surae

• presence of soleus spasticity

Exclusion Criteria:

• botulinum toxin injections or surgery in the lower limb respectively in the 6 and 12 months preceding the study

• any modification of the physical or orthopaedic therapy within the last two months

• minimal hip flexion above 20° in a clinical examination

• pain in the lower legs when standing or walking

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis

Intervention

Other:
• Rehabilitation involving strongly the trunk
The Rehabilitation involving strongly the trunk (RIST) leaded by a physiotherapist was based on exercises in different postures performed by the child each day that strongly involve the trunk to cope with balance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the peak of ankle negative power during the weight acceptance phase of gait	In watts per kg.	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Primary	Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait	In m/s²	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Primary	Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait	In m/s²	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Primary	Change of the score of the Trunk Control Measurement Scale (TCMS)	Score from 0 to 58. The higher the score, the better the trunk control.	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Primary	Change of the center of pressure velicoty during unstable sitting posturography	In mm²/s	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Primary	Change of the center of pressure sway area during unstable sitting posturography	In mm²	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Secondary	Change of the Dimensionless walking speed	Walking speed normalized to the length of the lower limb	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Secondary	Change of the dimensionless step width	Step width during walking normalized to the width of the pelvis	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Secondary	Change of the center of pressure velicoty during quiet standing	In mm²/s	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation
Secondary	Change of the center of pressure sway area during quiet standing	In mm²	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation