Cerebral Palsy, SpasticNCT04287673

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

A study testing Rehabilitation involving strongly the trunk in people with Cerebral Palsy, Spastic, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Cerebral Palsy, Spastic
What is being tested?: Rehabilitation involving strongly the trunk
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteFrance
Study dates: 20 Dec 2016to 30 Nov 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Gross Motor Function Classification System I or II
no or minimal contracture of the triceps surae
presence of soleus spasticity

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000

Other trials in France

About this study

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.

Conditions: Cerebral Palsy, Spastic
Being tested: Rehabilitation involving strongly the trunk
Keywords: Trunk control, Postural Control, Cerebral Palsy, Rehabilitation, Axial segments
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rehabilitation involving strongly the trunkOther
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.

Study groups in NCT04287673
Study group	Role	What they receive
RIST-UR	Experimental	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. Receives: Other: Rehabilitation involving strongly the trunk
UR-RIST	Experimental	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. Receives: Other: Rehabilitation involving strongly the trunk
Typically Developing children	No intervention	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)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of the peak of ankle negative power during the weight acceptance phase of gait
In watts per kg.
Measured: 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
Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait
In m/s²
Measured: 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
Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait
In m/s²
Measured: 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
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.
Measured: 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
Change of the center of pressure velicoty during unstable sitting posturography
In mm²/s
Measured: 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
Change of the center of pressure sway area during unstable sitting posturography
In mm²
Measured: 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 outcomes (4)

Change of the Dimensionless walking speed
Walking speed normalized to the length of the lower limb
Measured: 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
Change of the dimensionless step width
Step width during walking normalized to the width of the pelvis
Measured: 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
Change of the center of pressure velicoty during quiet standing
In mm²/s
Measured: 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
Change of the center of pressure sway area during quiet standing
In mm²
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 201630 Nov 2019

First posted27 Feb 2020
Study start20 Dec 2016
Primary completion14 Feb 2019
Study completion30 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04287673
Sponsor's protocol ID: IRR-2015-1
Status last verified: Jul 2024
First submitted: 5 Feb 2020
Last updated: 3 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy

All Cerebral Palsy, Spastic trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
ClinicalTrials.gov ID: NCT04287673
Acronym / sponsor ID: IRR-2015-1
Conditions: Cerebral Palsy, Spastic
Keywords: Trunk control, Postural Control, Cerebral Palsy, Rehabilitation, Axial segments
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
Study start: 20 Dec 2016 (actual)
Primary completion: 14 Feb 2019 (actual)
Study completion: 30 Nov 2019 (actual)
First posted: 27 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
RIST-UR	Experimental	Other: Rehabilitation involving strongly the trunkGroup 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.
UR-RIST	Experimental	Other: Rehabilitation involving strongly the trunkGroup 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	No intervention	–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)

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Gross Motor Function Classification System I or II
no or minimal contracture of the triceps surae
presence of soleus spasticity

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rehabilitation involving strongly the trunkThe 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.	Other	RIST-UR, UR-RIST

Primary outcome

Change of the peak of ankle negative power during the weight acceptance phase of gait
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
In watts per kg.
Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait
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
In m/s²
Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait
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
In m/s²
Change of the score of the Trunk Control Measurement Scale (TCMS)
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
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
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
In mm²/s
Change of the center of pressure sway area during unstable sitting posturography
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
In mm²

4 secondary outcomes

Change of the Dimensionless walking speed
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
Change of the dimensionless step width
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
Change of the center of pressure velicoty during quiet standing
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
Change of the center of pressure sway area during quiet standing
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.

Related trials for Cerebral Palsy, Spastic

Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christian Beyaert, PU-PH principal investigator

University of Lorraine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the peak of ankle negative power during the weight acceptance phase of gait (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04287673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.