NCT04899284

Brief Summary

The aim of this study is to measure the impact of early bimanual stimulation in babies with clinical signs of underuse of one hand. The observation focuses on the developmental curve of hands use. The intervention is provided by the family environment and takes place in the child's familiar surroundings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 21, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

10 days

First QC Date

May 18, 2021

Last Update Submit

May 25, 2023

Conditions

Cerebral Palsy

Keywords

Unilateral cerebral palsyUnilateral brain lesionInfantile cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • Hand Assessment in Infants (HAI)

    The HAI was developed for infants 3 to 12 months of age; the test is performed by filming the baby during a 10-minute play session. The examiner stimulates the baby with specific toys to induce hand actions, separately and together. Scoring includes 12 unimanual and five bimanual items, each scored on a 3-modality response scale (0, 1 or 2 points). The HAI provides a score for each of the upper limbs (out of 24 points), allowing quantification of possible asymmetry in the form of an index, as well as an interval measure of hand use (the total raw score out of 58 is converted to a scale from 0 to 100 points).

    Change from baseline at 2 months with a weekly evaluation

Secondary Outcomes (4)

  • Actimetry

    Change from baseline at 2 months with a weekly evaluation

  • Goal Attainment Scales

    Change from baseline at 2 months with a weekly evaluation

  • Compliance

    Change from baseline at 2 months with a weekly evaluation

  • Parent satisfaction questionnaire

    2 months

Study Arms (1)

Infants eligible for Early Intensive Bimanual Stimulation

EXPERIMENTAL

Infants between 3 and 12 months of age at the time of inclusion, with unilateral brain injury and clinical signs of underuse of one of the two upper limbs

Other: Early Intensive Bimanual Stimulation

Interventions

Early Intensive Bimanual StimulationOTHER

Early intensive bimanual stimulation program for infants showing early signs of UCP, delivered by the family environment, in the child's familiar surroundings, under the guidance of a therapist, over a period of 2 months.

Infants eligible for Early Intensive Bimanual Stimulation

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical signs of underuse of one of the two upper limbs, (reported by the parents and authenticated by the HAI)
  • Unilateral brain injury
  • Brain imaging performed at birth or upon initial parental concerns
  • Possibility of a home visit by the occupational therapist
  • At least one parent volunteering to actively participate in the intensive stimulation
  • Parental consent to enter the study
  • Consent for image rights

You may not qualify if:

  • Prematurity
  • Lack of interest suggesting underlying associated disorders
  • Active epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Lyon, 69005, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rachel Bard-Pondarré, OT

    Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France

    PRINCIPAL INVESTIGATOR

  • Emmanuelle Chaléat-Valayer, PhD

    Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France

    STUDY DIRECTOR

  • Carole Vuillerot, PhD

    Hopital Femme Mère Enfant, l'Escale MPR pédiatrique (Hospices Civils de Lyon). Bron, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 24, 2021

Study Start

April 21, 2021

Primary Completion

May 1, 2021

Study Completion

January 1, 2022

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)