NCT02720432

Brief Summary

This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 29, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

March 2, 2016

Last Update Submit

December 2, 2021

Conditions

Stroke

Keywords

early intervention, infant

Outcome Measures

Primary Outcomes (3)

  • Change in the score of the Hand assessment for infants (HAI)

    The HAI is the very new assessment tool to evaluate the hand function and asymmetry in infants age from 2 till 8 months post term.

    before (around 4 months) and after 18 weeks of intervention (around 9 months)

  • Change in the score of the Infant motor profile

    The IMP is a video-based assessment to evaluate the spontaneous motor behavior of infants from 3 months till independent walking around 18 months of age

    before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

  • Change in the score of the Alberta infant motor scale

    The AIMS is a standardized observational scale to assess the gross motor development from birth till independent walking around 18 months of age.

    before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

Secondary Outcomes (3)

  • Bayley scales for infant development-third edition

    between 22 and 24 months (2 years)

  • Parental sense of competence scale

    before intervention (around 4months)

  • Questionnaire satisfaction and impact

    after the intervention (around 9 months)

Study Arms (3)

CIMT

EXPERIMENTAL

A soft splint or restraint will be posed to best functioning hand of the infant only during the therapy session. Parents will be educated to perform the therapy, which consists of stimulation of reaching and grasping with the hemiplegic arm. The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform CIMTfor 30 minutes, 6 days a week.

Other: CIMT

HABIT

EXPERIMENTAL

No restraint will be implemented and instead of promoting unilateral grasping, bimanual grasping will be stimulated. Toys will be precisely selected to stimulate progressed bimanual grasping. The approach of the therapist and parents remain equal. The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform HABIT for 30 minutes, 6 days a week.

Other: HABIT

Baby-massage

SHAM COMPARATOR

3 sessions of baby-massage will be given by a qualified instructor

Other: baby-massage

Interventions

CIMTOTHER

Constraint-induced movement therapy

CIMT
HABITOTHER

hand-arm bimanual intensive training

HABIT
baby-massageOTHER

instructions for baby-massage

Baby-massage

Eligibility Criteria

Age4 Months - 8 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with a perinatal stroke confirmed on neonatal imaging and from who the parents speaks Dutch and live in Belgium, will be included in the study. Only infants showing abnormal 'general movements' between 10 and 15 weeks will be eligible for the intervention part.

You may not qualify if:

  • Infants with severe genetic abnormalities or malformations, with severe visual impairments or with uncontrolled seizures will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paul Govaert, Dr

    Universiteit Gent, vakgroep REVAKI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 25, 2016

Study Start

June 29, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2020

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)