Trials / Completed
CompletedNCT01864811
Effect of Baby-CIMT in Infants Younger Than 12 Months
The Efficacy of Constraint Induced Movement Therapy for Babies (Baby-CIMT) in Infants Below 12 Month With Risk of Developing Unilateral Cerebral Palsy, a Study Protocol of a Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Karolinska Institutet · Academic / Other
- Sex
- All
- Age
- 3 Months – 8 Months
- Healthy volunteers
- Not accepted
Summary
A randomized control trial investigating if an early intervention program of modified Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age will improve hand function in children with risk for developing cerebral palsy.
Detailed description
The investigators hypothesis is that Baby-CIMT including intensive specific task oriented training is more preferable than general stimulation which is the assumption for baby massage used in the control group. The intervention protocol is developed at Astrid Lindgren Children hospital, Stockholm Sweden.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Baby-CIMT | Baby-CIMT is a very much modified model of constraint induced movement therapy for infants. It is developed to suit small children and their needs of stimulation. The infant should wear a comfortable glove on the less affected hand, while stimulating the use of the affected hand 30 minutes per day during 2 periods of 6-weeks training before 12 month. The hand training provides the baby with amusing and easily handled toys. |
| BEHAVIORAL | Baby-Massage | For baby massage, there will be a special instructional course by a health professional certified for baby massage. Massage should be given every day during 2 periods of 6 weeks. Families will be responsible for the massage. |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2015-12-01
- Completion
- 2017-12-01
- First posted
- 2013-05-30
- Last updated
- 2018-08-10
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01864811. Inclusion in this directory is not an endorsement.