IMPACT of an Instrumented Measurement on a Performance Assessment in Cerebral Palsy Treatment (IMPACT²)

June 10, 2025 updated by: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69322
        • CMCR des Massues

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
Other: AHA Instrumented then AHA Not Instrumented

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.
Experimental: Group 1
Other: AHA Not Instrumented then AHA Instrumented
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bimanual Performance Score
Time Frame: 1 day
The score of the participant at the Assisting Hand Assessment.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

June 29, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT²

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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