Cerebral PalsyIMPACT²NCT06565000
IMPACT of an Instrumented Measurement on a Performance Assessment in Cerebral Palsy Treatment
A study testing AHA Not Instrumented then AHA Instrumented and AHA Instrumented then AHA Not Instrumented in people with Cerebral Palsy, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
Trial 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 ?… Read more about this study
- Who is it for?
- Ages 18 months to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- AHA Not Instrumented then AHA Instrumented and AHA Instrumented then AHA Not Instrumented
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unilateral cerebral palsy
- With an Occupational therapy assessment planed with the duration of the study
Who cannot join
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Palsy
- Being tested
- AHA Not Instrumented then AHA Instrumented, AHA Instrumented then AHA Not Instrumented
- Keywords
- Quantified Motion Analysis, Performance Assessment, Bimanual Performance, Unilateral Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHA Not Instrumented then AHA InstrumentedOther
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.
AHA Instrumented then AHA Not InstrumentedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: AHA Not Instrumented then AHA Instrumented |
| Group 2 | Experimental | Not described Receives: Other: AHA Instrumented then AHA Not Instrumented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bimanual Performance Score
The score of the participant at the Assisting Hand Assessment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start18 Sep 2023
- Primary completion29 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565000
- Sponsor's protocol ID
- IMPACT²
- Acronym
- IMPACT²
- Status last verified
- Jun 2025
- First submitted
- 6 Feb 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT of an Instrumented Measurement on a Performance Assessment in Cerebral Palsy Treatment
- ClinicalTrials.gov ID
- NCT06565000
- Acronym / sponsor ID
- IMPACT² / IMPACT²
- Conditions
- Cerebral Palsy
- Keywords
- Quantified Motion Analysis, Performance Assessment, Bimanual Performance, Unilateral Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: AHA Not Instrumented then AHA Instrumented |
| Group 2 | Experimental | Other: AHA Instrumented then AHA Not Instrumented |
Who may qualify
- Ages
- 18 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Unilateral cerebral palsy
- With an Occupational therapy assessment planed with the duration of the study
Key exclusion criteria (1 listed)
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHA Not Instrumented then AHA InstrumentedFirst, 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. | Other | Group 1 |
| AHA Instrumented then AHA Not InstrumentedFirst, 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. | Other | Group 2 |
Primary outcome
Bimanual Performance Score
Time frame: 1 day
The score of the participant at the Assisting Hand Assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHA Not Instrumented then AHA Instrumented and AHA Instrumented then AHA Not Instrumented in people with Cerebral Palsy, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bimanual Performance Score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.