The primary aim of the study is to investigate the feasibility of a RCT study on effectivity and workingmechanisms of HRT in children with CP. The Doel van deze studie is ten eerste de feasiblity onderzoeken van een toekomstige RCT study over het…
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of combination of measurements: gross motor function (primary
outcome RCT), daily function, self confidence and quality of life (secundary
outcome measures), spasticity and postural control during a daily activity,
i.e. reaching, and quantitative analysis of video recordings of HRT-sessions
(workingmechanisms).
Secondary outcome
Describe systematically contents of HRT-intervention.
Background summary
Children with cerebraly palsy (CP) more often have problems in daily life
activities such as mobility, self care and social function than typically
developing peers. Dysfunctional postural control plays a prominent role in
these problems, possibly in concert with or mediated by spasticity. Horseback
riding therapy (HRT) is one of the therapies applied in children with CP to
improve daily life activities supposedly by means of reducing spasticity and
improving postural control. Various studies on HRT have been published, but
due to lack of rigour of the studies evidence on effectivity of HRT in children
with CP is still lacking. Also workingmechanisms are unclear, e.g. the role of
spasticity is uncertain.
Study objective
The primary aim of the study is to investigate the feasibility of a RCT study
on effectivity and workingmechanisms of HRT in children with CP. The Doel van
deze studie is ten eerste de feasiblity onderzoeken van een toekomstige RCT
study over het effect en de werkingsmechanismen van HRT bij kinderen met CP.
The secundary aim of the study is to describe the contents of the
HRT-intervention.
Study design
Feasibility study. Case study, with 6 cases and 3 repeated measurements (T0,
T1, T2). AB-design, i.e., an A fase without HRT and a B fase with HRT. T0: 6
weeks prior to onset of HRT. T1: immediately prior to onset of HRT. T2:
immediately after 6 weeks of HRT (2x/week).
Intervention
The children receive 2x/week 1 hour of HRT for a period of 6 weeks. Regular
therapy will be continued.
Study burden and risks
The study is not associated with risks. The burden of the study consists of HRT
(which children with CP generally enjoy), 3x asssessment of motor function
(±20-30 min), 2x child friendly surface EMG assessment (±45 min, T1 en T2), 3x
2 mini-questionnaires for the child (±2 min), 3x interview parents (±30-45
min).
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
- Unilateral or bilateral cerebral palsy
- GMFCS level II-III
- 6-12 year
Exclusion criteria
- Evident dyskinesia
- History of selective dorsal rhizotomy
- Botulinum toxin therapy during preceding 6 months
- Orthopedic surgery during preceding last year.
- Non-optimaly regulated epilepsy, defined as presence of > 2 fits/week
- Learning disability interfering with comprehension of riding instructions
- Allergy for horses
- Fear for horses
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39372.042.12 |