- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03122171
Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
29. oktober 2020 opdateret af: NYU Langone Health
The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.
Twelve children, aged 4-17 years, who have cerebral palsy and limitations in their ability to use their hands, will be enrolled.
All participants will be fitted with a 3D printed arm/hand prosthesis and receive 8 occupational therapy sessions.
Each subject will be evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up.
The evaluation will include assessment of (1)passive and active arm/hand movement and (2)functional hand skills using several standardized tests.
The results from the pre-treatment and the two post-treatment evaluations will be compared.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New York
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New York, New York, Forenede Stater, 10016
- New York University School of Medicine
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis: cerebral palsy
- 4-17 years old
- MACS levels III - V
- Active movement of wrist or elbow
Exclusion Criteria:
- MACS levels I, II
- Botox or orthopedic surgery in past 6 months
- Severe contractures
- Lack of voluntary arm motion
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Prosthesis
|
Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score
Tidsramme: Week 8
|
The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands.
The AHA measures how effectively the affected hand and arm is used in bimanual performance.
An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session.
Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective).
The range of sum scores is 22-88 points.
A clinical significant increase in score indicates an increase in quality of performance.
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Week 8
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Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment
Tidsramme: 8 weeks
|
The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living.
Scores range from 0-10; the higher the score, the better the quality of movement.
An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.
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8 weeks
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Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores
Tidsramme: Week 8
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The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement.
An increase in score indicates an increase in upper limb movement quality.
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Week 8
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment
Tidsramme: 8 weeks
|
The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model.
7 sub-tests will be reported on.
Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.
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8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Alice Chu, MD, NYU Langone Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2017
Primær færdiggørelse (Faktiske)
13. januar 2020
Studieafslutning (Faktiske)
13. januar 2020
Datoer for studieregistrering
Først indsendt
17. april 2017
Først indsendt, der opfyldte QC-kriterier
17. april 2017
Først opslået (Faktiske)
20. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-02093
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
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produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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