Asymmetry in infancy - the effect of pediatric physical therapy on the course of positional preference, deformational plagiocephaly and subsequent developmental delay
| ISRCTN | ISRCTN84132771 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84132771 |
| Secondary identifying numbers | NTR440 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 06/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr L.A. van Vlimmeren
Scientific
Scientific
Bernhoven Hospital Veghel
Department of Physical Therapy
P.O. Box 10.000
Veghel
5460 DA
Netherlands
| Phone | +31 (0)413 381935 |
|---|---|
| l.vanvlimmeren@bernhoven.nl |
Study information
| Study design | Randomised, single blinded, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Asymmetry in infancy - a prospective, randomised trial: the effect of pediatric physical therapy on the course of postional preference, deformational plagiocephaly and subsequent developmental delay, in children of 6 weeks to 24 months of age, measured with plagiocephalometry, range of motion tests and motor assessment |
| Study objectives | Pediatric physical therapy is effective in asymmetry in infancy, especially to positional preference, deformational plagiocephaly and natural course of asymmetrical motor development, established by plagiocephalometry, range of motion tests and motor assessment. |
| Ethics approval(s) | Ethics approval received from the local ethics committee |
| Health condition(s) or problem(s) studied | No condition, healthy person |
| Intervention | Study population: Group 1: Positional preference (+/- deformational plagiocephaly) with pediatric physical therapy Group 2: Positional preference (+/- deformational plagiocephaly) without pediatric physical therapy Group 3: Deformational plagiocephaly without positional preference Group 4: No positional preference and/or deformational plagiocephaly |
| Intervention type | Other |
| Primary outcome measure | Parameters: 1. Shape of the head established by the features and values of plagiocephalometry 2. Active and passive range of motion measurements of the cervical column 3. Motor development by the Alberta Infant Motor Scale and the Bailey Scales of Infant Development second edition All outcome parameters will be established at 4 investigation moments: T0 to T3 T0 = 6-8 weeks T1 = 6 months T2 = 12 months T3 = 24 months |
| Secondary outcome measures | Answers to the questionnaires to investigate the experiences of parents of all participating children |
| Overall study start date | 22/01/2005 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Weeks |
| Upper age limit | 8 Weeks |
| Sex | Both |
| Target number of participants | 385 |
| Key inclusion criteria | 1. Healthy infants of 6 to 8 weeks of age, born at or after a gestational age of 36 weeks or more, without dysmorphisms or syndromatic symptoms 2. With or without positional preference of the head and with or without deformational plagiocephaly 3. Positional preference and deformational plagiocephaly are based on positional torticollis |
| Key exclusion criteria | 1. Positional preference caused by pathology, for example congenital muscular torticollis, structural scoliosis, osseal disorders, cerebral palsy 2. Dysmorphism 3. Syndromes 4. Synostotic plagiocephaly (craniosynostosis) |
| Date of first enrolment | 22/01/2005 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Bernhoven Hospital Veghel
Veghel
5460 DA
Netherlands
5460 DA
Netherlands
Sponsor information
Bernhoven Hospital Veghel (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 10.000
Veghel
5460 DA
Netherlands
"ROR" |
https://ror.org/05b5x0e19 |
|---|
Funders
Funder type
Research organisation
The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/08/2008 | Yes | No |
