Cerebral Palsy, SpasticNCT03449498
The Effects of Intensive Therapy on Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
A study testing Qualitative functional therapy and Functional therapy in people with Cerebral Palsy, Spastic, run by University Ghent at 1 site in Belgium.
Trial summary
Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Qualitative functional therapy and Functional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2017to 15 Sep 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- spastic type of CP
- bilateral motor involvement (both diplegia and quadriplegia)
- GMFCS-level II and III
- 6 to 12 years old
- cognition: able to understand and execute instructions in a proper way and sufficient concentration (both during the measurements as during the camp).
Who cannot join
- mixed form of CP (with ataxia or dystonia)
- Botulinum Toxin-A injections within six months prior to the camp
- multilevel orthopedic surgery within one year prior to the camp
- selective dorsal rhizotomy within two years prior to the camp
- spinal fusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intensive Therapy on Quantitative and Qualitative Parameters of Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent.
This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.
Read the detailed description
Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent.
This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Qualitative functional therapy, Functional therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative functional therapyOther
Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Six functional activities focusing on lower limbs and trunk are performed: walking, stair climbing, balance, transfers, trunk control, and Wii (combination of functional activities in sitting and/or standing). A group of clinical experts composes a set of exercises for each of these activities, however individual adaptations according to the needs and abilities of the child can be still be done. Quality of movement (alignment, weightshift, dissociation, coordination and stability) is hereby very important. The theme 'circus' is used to enhance the motivation of the children.
Functional therapyOther
Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Goals are set with the parents and the children. During the camp children work on obtaining these goals in a exclusively functional way.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Intensive qualitative functional therapy Receives: Other: Qualitative functional therapy |
| control group | Experimental | Intensive functional therapy Receives: Other: Functional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM)
The Gross Motor Function Measure (GMFM)25 is used for the evaluation of gross motor function. The GMFM-88 exists of 88 items categorized into five dimensions: Lying \& Rolling (Dim A), Sitting (Dim B), Crawling \& Kneeling (Dim C), Standing (Dim D), and Walking, Running \& Jumping (Dim E). The Quality Function Measure (QFM)26 evaluates the quality of execution of the items of Dim D and E of the GMFM. Five attributes are scored separately by use of video scoring: alignment, coordination, weight shift, stability and dissociated movements.
GMFM: scale ranges fo each item: 0-3 (0 is the minimum score, 3 is the maximum score). There is a total score for all dimensions and a subscore for each dimension, expressed in a percentage. QFM: scale ranges for each qualitative attribute: 0-3 (0 is the minimum score, 3 the maximum score). There is a total score for each qualitative attribute.
Measured: 1h30
Secondary outcomes (7)
3D-motion analysis system movements of lower limbs and trunk during gait
3D-movement analysis is used to evaluate lower limb and trunk movements during gait. The children walk barefoot over a 10m walkway at self-selected speed, while marker trajectories on trunk and lower limbs are captured by 12 infrared cameras (VICON system). Spatiotemporal and kinematic parameters will be evaluated.
Measured: 1h
Range of motion (passive and active)
Assessed with a goniometer (degrees) in standardised positions.
Measured: 10 minutes
Timed Up and Go
Assesses dynamic balance and mobility of the child.
Measured: 5 minutes
1 Minute Walking Test
Evaluates walking ability and endurance of the child.
Measured: 5 minutes
Muscle tone
Modified Ashworth Scale, Tardieu Scale. Scale ranges: 0-4 (0 is the maximum score, 4 is the minimum score).
Measured: 10 minutes
Muscle strength
Daniels and Worthingham's Manual Muscle Testing. Scale ranges: 0-5 (0 is the minimum score, 5 is the maximum score).
Measured: 10 minutes
Trunk Control Measurement Scale
Trunk control in sitting is evaluated with the Trunk Control Measurement Scale (TCMS). The TCMS evaluates two prime aspects of trunk control during functional activities: (1) being a stable base for upper and lower limb movements, and (2) being an actively moving body segment. It consists of three subscales: 'static sitting balance', 'selective movement control' and 'dynamic reaching'.
Scale range: 0-3 (0 is the minimum score, 3 is the maximum score).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Jun 2017
- Primary completion15 Sep 2019
- Study completion15 Sep 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.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449498
- Sponsor's protocol ID
- 2017/0678
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2018
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intensive Therapy on Quantitative and Qualitative Parameters of Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT03449498
- Acronym / sponsor ID
- 2017/0678
- Conditions
- Cerebral Palsy, Spastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 28 Feb 2018 (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.
Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent.
This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.
Detailed description
Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent.
This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Qualitative functional therapyIntensive qualitative functional therapy |
| control group | Experimental | Other: Functional therapyIntensive functional therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- spastic type of CP
- bilateral motor involvement (both diplegia and quadriplegia)
- GMFCS-level II and III
- 6 to 12 years old
- cognition: able to understand and execute instructions in a proper way and sufficient concentration (both during the measurements as during the camp).
Key exclusion criteria (5 listed)
- mixed form of CP (with ataxia or dystonia)
- Botulinum Toxin-A injections within six months prior to the camp
- multilevel orthopedic surgery within one year prior to the camp
- selective dorsal rhizotomy within two years prior to the camp
- spinal fusion
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 |
|---|---|---|
| Qualitative functional therapyCamps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Six functional activities focusing on lower limbs and trunk are performed: walking, stair climbing, balance, transfers, trunk control, and Wii (combination of functional activities in sitting and/or standing). A group of clinical experts composes a set of exercises for each of these activities, however individual adaptations according to the needs and abilities of the child can be still be done. Quality of movement (alignment, weightshift, dissociation, coordination and stability) is hereby very important. The theme 'circus' is used to enhance the motivation of the children. | Other | study group |
| Functional therapyCamps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Goals are set with the parents and the children. During the camp children work on obtaining these goals in a exclusively functional way. | Other | control group |
Primary outcome
Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM)
Time frame: 1h30
The Gross Motor Function Measure (GMFM)25 is used for the evaluation of gross motor function. The GMFM-88 exists of 88 items categorized into five dimensions: Lying \& Rolling (Dim A), Sitting (Dim B), Crawling \& Kneeling (Dim C), Standing (Dim D), and Walking, Running \& Jumping (Dim E). The Quality Function Measure (QFM)26 evaluates the quality of execution of the items of Dim D and E of the GMFM. Five attributes are scored separately by use of video scoring: alignment, coordination, weight shift, stability and dissociated movements. GMFM: scale ranges fo each item: 0-3 (0 is the minimum score, 3 is the maximum score). There is a total score for all dimensions and a subscore for each dimension, expressed in a percentage. QFM: scale ranges for each qualitative attribute: 0-3 (0 is the minimum score, 3 the maximum score). There is a total score for each qualitative attribute.
7 secondary outcomes
3D-motion analysis system movements of lower limbs and trunk during gait
Time frame: 1h
Range of motion (passive and active)
Time frame: 10 minutes
Timed Up and Go
Time frame: 5 minutes
1 Minute Walking Test
Time frame: 5 minutes
Muscle tone
Time frame: 10 minutes
Muscle strength
Time frame: 10 minutes
Trunk Control Measurement Scale
Time frame: 30 minutes
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 18 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative functional therapy and Functional therapy in people with Cerebral Palsy, Spastic, run by University Ghent at 1 site in Belgium.
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 5 inclusion and 5 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 18 Dec 2023. 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 Belgium. 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?
Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM) (time frame: 1h30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2023.