NCT06565000

Brief Summary

The goal of this study is to assess the impact of passive reflective markers on bimanual performance assessment scores in children with unilateral cerebral palsy. The main questions it aims to answer are:

  • Is it possible to instrument performance assessment without changing the functionnal behaviour of the patient ?
  • How is this behavious modified ? During their usual occupational therpy assessment at the CMCR Massues, participants will do a second bimanual performance assessment with passive reflection markers taped on their trunk, humerus and forearm. The glocal scores and sub items scors of both instrumented and non instrumented assessment will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

September 18, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

February 6, 2024

Last Update Submit

June 10, 2025

Conditions

Keywords

Quantified Motion AnalysisPerformance AssessmentBimanual PerformanceUnilateral Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Bimanual Performance Score

    The score of the participant at the Assisting Hand Assessment.

    1 day

Study Arms (2)

Group 1

EXPERIMENTAL
Other: AHA Not Instrumented then AHA Instrumented

Group 2

EXPERIMENTAL
Other: AHA Instrumented then AHA Not Instrumented

Interventions

First, the participant will undergo a performance assessment using the Assisting Hand Assessment test, following the standard protocol in the occupational therapy room. Subsequently, they will proceed to the motion analysis laboratory located across the hall, where an engineer will outfit them with motion capture markers. These markers comprise ultra-reflective spheres affixed to specific anatomical landmarks on their upper limbs using hypoallergenic tape. Afterward, the participant's functional capacity will be evaluated using the Melbourne Assessment. Finally, a second round of assessment using the Assisting Hand Assessment will be conducted.

Group 1

First, the participant will proceed to the motion analysis laboratory located across the hall, where an engineer will outfit them with motion capture markers. These markers comprise ultra-reflective spheres affixed to specific anatomical landmarks on their upper limbs using hypoallergenic tape. Afterward, the participant's functional capacity will be evaluated using the Melbourne Assessment. Then, will undergo a performance assessment using the Assisting Hand Assessment test. Finally, they will go to the occupational therapy room where a second round of assessment using the Assisting Hand Assessment without markers will be conducted.

Group 2

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Unilateral cerebral palsy
  • With an Occupational therapy assessment planed with the duration of the study

You may not qualify if:

  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMCR des Massues

Lyon, 69322, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

August 21, 2024

Study Start

September 18, 2023

Primary Completion

June 29, 2024

Study Completion

June 30, 2024

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations