The Effects of Intensive Therapy on Quantitative and Qualitative Parameters of Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
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|ClinicalTrials.gov Identifier: NCT03449498|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy, Spastic||Other: Qualitative functional therapy Other: Functional therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RCT|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effects of Intensive Therapy on Quantitative and Qualitative Parameters of Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||September 15, 2019|
|Estimated Study Completion Date :||September 15, 2019|
Experimental: study group
Intensive qualitative functional therapy
Other: Qualitative functional therapy
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.
Experimental: control group
Intensive functional therapy
Other: Functional therapy
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.
- Quality Measurement Scale [ Time Frame: 1h30 ]Based on the GMFM (Gross Motor Measurement Scale) 5 qualitative parameters are evaluated: alignment, weightshift, dissociation, coordination and stability.
- Trunk Control Measurement Scale [ Time Frame: 30 minutes ]Static and dynamic sitting balance.
- 3D-motion analysis system movements of lower limbs and trunk during gait [ Time Frame: 1h ]
- Clinical outcomes [ Time Frame: 30 minutes ]Range of motion (passive and active), muscle tone, muscle strength
- Timed Up and Go [ Time Frame: 5 minutes ]Assesses dynamic balance and mobility of the child.
- 1 Minute Walking Test [ Time Frame: 5 minutes ]Evaluates walking ability and endurance of the child
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449498
|Contact: Vanessa van Tittelboom||09 332 44 firstname.lastname@example.org|
|Contact: Christine Van den Broeck||09 332 69 email@example.com|
|Gent, Belgium, 9000|
|Contact: Vanessa van Tittelboom|