Back to resultsAssociated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
Primary Purpose
Cerebral Palsy, Spastic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation involving strongly the trunk
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Trunk control, Postural Control, Cerebral Palsy, Rehabilitation, Axial segments
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
RIST-UR
UR-RIST
Typically Developing children
Arm Description
Group having performed the rehabilitation involving strongly the trunk for the first 3 months and then having performed its usual rehabilitation for the last 3 months. Before and after each 3-months period, an evaluation of the postural control of the trunk (using the Trunk Control Measurement Scale and a dynamic posturography on an unstable sitting device) and a clinical gait analysis were performed.
Group having performed its usual rehabilitation for the first 3 months and then having performed the rehabilitation involving strongly the trunk for the last 3 months. Before and after each 3-months period, an evaluation of the postural control of the trunk (using the Trunk Control Measurement Scale and a dynamic posturography on an unstable sitting device) and a clinical gait analysis were performed.
Typically developing children who served as a control group in the first assessment (Trunk Control Measurement Scale, dynamic posturography on an unstable sitting device, clinical gait analysis)
Outcomes
Primary Outcome Measures
Change of the peak of ankle negative power during the weight acceptance phase of gait
In watts per kg.
Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait
In m/s²
Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait
In m/s²
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 of the center of pressure velicoty during unstable sitting posturography
In mm²/s
Change of the center of pressure sway area during unstable sitting posturography
In mm²
Secondary Outcome Measures
Change of the Dimensionless walking speed
Walking speed normalized to the length of the lower limb
Change of the dimensionless step width
Step width during walking normalized to the width of the pelvis
Change of the center of pressure velicoty during quiet standing
In mm²/s
Change of the center of pressure sway area during quiet standing
In mm²
Full Information
NCT ID
NCT04287673
First Posted
February 5, 2020
Last Updated
February 25, 2020
Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
1. Study Identification
Unique Protocol Identification Number
NCT04287673
Brief Title
Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
Official Title
Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Trunk control, Postural Control, Cerebral Palsy, Rehabilitation, Axial segments
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIST-UR
Arm Type
Experimental
Arm Description
Group having performed the rehabilitation involving strongly the trunk for the first 3 months and then having performed its usual rehabilitation for the last 3 months.
Before and after each 3-months period, an evaluation of the postural control of the trunk (using the Trunk Control Measurement Scale and a dynamic posturography on an unstable sitting device) and a clinical gait analysis were performed.
Arm Title
UR-RIST
Arm Type
Experimental
Arm Description
Group having performed its usual rehabilitation for the first 3 months and then having performed the rehabilitation involving strongly the trunk for the last 3 months.
Before and after each 3-months period, an evaluation of the postural control of the trunk (using the Trunk Control Measurement Scale and a dynamic posturography on an unstable sitting device) and a clinical gait analysis were performed.
Arm Title
Typically Developing children
Arm Type
No Intervention
Arm Description
Typically developing children who served as a control group in the first assessment (Trunk Control Measurement Scale, dynamic posturography on an unstable sitting device, clinical gait analysis)
Intervention Type
Other
Intervention Name(s)
Rehabilitation involving strongly the trunk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the peak of ankle negative power during the weight acceptance phase of gait
Description
In watts per kg.
Time Frame
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
Title
Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait
Description
In m/s²
Time Frame
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
Title
Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait
Description
In m/s²
Time Frame
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
Title
Change of the score of the Trunk Control Measurement Scale (TCMS)
Description
Score from 0 to 58. The higher the score, the better the trunk control.
Time Frame
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
Title
Change of the center of pressure velicoty during unstable sitting posturography
Description
In mm²/s
Time Frame
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
Title
Change of the center of pressure sway area during unstable sitting posturography
Description
In mm²
Time Frame
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 Outcome Measure Information:
Title
Change of the Dimensionless walking speed
Description
Walking speed normalized to the length of the lower limb
Time Frame
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
Title
Change of the dimensionless step width
Description
Step width during walking normalized to the width of the pelvis
Time Frame
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
Title
Change of the center of pressure velicoty during quiet standing
Description
In mm²/s
Time Frame
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
Title
Change of the center of pressure sway area during quiet standing
Description
In mm²
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Beyaert, PU-PH
Organizational Affiliation
University of Lorraine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
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