Cerebral PalsyNCT04243590
Turkish Version of Hand-Use-at-Home Questionnaire
An observational study of Cerebral Palsy and Brachial Plexus Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the validity and reliability of the Turkish Version of parent-rated Hand-Use-at- Home questionnaire (HUH) in children with neonatal brachial plexus palsy or unilateral cerebral palsy. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Cerebral Palsy, Brachial Plexus Palsy
- What is being tested?
- Hand-Use-at-Home Questionnaire (HUH), Pediatric Outcome Data Collection Instrument (PODCI) and Children's Hand-Use Experience Questionnaire (CHEQ)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Jan 2022
- Phase
- Observational
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 42 unilateral cerebral palsy patients and 25 brachial plexus palsy between 3 - 10 years of age.
Who may be able to join
- Confirmed diagnosis of unilateral cerebral palsy or obstetric brachial plexus palsy
- Age between 3 - 10
- Volunteer to study
Who cannot join
- Having a visual disorder
- History of botulinum toxin injection and surgery for upper extremity and hand in the last 6 months.
- Having robotic rehabilitation or intensive treatments such as constraint-induced movement therapy to increase upper extremity use in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34890
About this study
Official title: Validity and Reliability of the Turkish Version of Hand-Use-at-Home Questionnaire in Children With Neonatal Brachial Plexus Palsy or Unilateral Cerebral Palsy.
To investigate the validity and reliability of the Turkish Version of parent-rated Hand-Use-at- Home questionnaire (HUH) in children with neonatal brachial plexus palsy or unilateral cerebral palsy.
Read the detailed description
Cerebral Palsy (CP) is defined as a permanent but non-progressive disorder group that affects the developing fetal or infantile brain, leading to impairment in movement and posture, thereby limiting physical activity and participation. The prevalence of CP in society is around 0.21%. In a study conducted in Turkey, this ratio of 4.4 / 1000 live births has been reported. Motor disorders in CP often are accompanied by sensory, perceptual, cognitive, communicative and behavioral problems and secondary musculoskeletal problems.
Obstetric brachial plexus (OBP) injury is a common peripheral nerve injury in children. Its incidence is reported between 0.42 and 5.1 per 1000 live births. As the primary mechanism of injury, it is accepted that traction or compression of all or part of the brachial plexus.
In these patients, weakness in the upper extremity, long-term contractures, and difficulties in the use of the extremities occurs due to the damage of nerves. In both diseases, patients have difficulty in bimanual activities.
Many treatment methods focus on increasing the use of upper extremities of patients and ensuring their independence in daily life activities. There are many methods for evaluating the hand use performance of patients and the effectiveness of different treatment methods. However, these clinical evaluation methods often do not reflect the patient's performance at home, at school, in their daily living environments.
The "Hand Use at Home (HUH)" questionnaire, which was created to be evaluated by parents, was developed in 2017 for measuring and evaluating the spontaneous use time of unilateral paretic children aged 3-10 in the affected hand and arm daily life activities.
The validity and reliability of the questionnaire were determined in children with obstetric brachial plexus paralysis and unilateral SP.
The purpose of this study; The translation of the HUH questionnaire into Turkish is to investigate its cultural adaptation, validity, and test-retest reliability.
- Conditions
- Cerebral Palsy, Brachial Plexus Palsy
- Being tested
- Hand-Use-at-Home Questionnaire (HUH), Pediatric Outcome Data Collection Instrument (PODCI), Children's Hand-Use Experience Questionnaire (CHEQ)
- Keywords
- brachial plexus, unilateral cerebral palsy, hand function, child rehabilitation, upper extremity, hand use at home questionnaire
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-Use-at-Home Questionnaire (HUH)Behavioural
The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/ often = score 1, always = score 2). A sum score can be calculated (range 0-36).
Pediatric Outcome Data Collection Instrument (PODCI)Behavioural
The PODCI is designed to assess different aspects of daily living in children with musculoskeletal disorders. It has excellent psychometric properties, and it is a widely accepted instrument to provide parent/patient-reported information about upper extremity functioning. A Dutch version is available and it is validated for children with neonatal brachial plexus palsy. It consists of 85 questions and five scale scores and one total score can be calculated (range for all scales and total score 0-100, higher scores indicating better functioning/quality of life). Only the Upper Extremity and Physical Function Scale (8 items) were used in this study since this scale provides information about difficulties performing activities using the arms/hands (score 0-100; lower score, more difficulties).
Children's Hand-Use Experience Questionnaire (CHEQ)Behavioural
The CHEQ is a questionnaire for children (aged 6-18) with unilateral functional limitations of hand use and is well validated for children with unilateral cerebral palsy. It was only partially validated for use in children with neonatal brachial plexus palsy and has not yet been used in studies. Therefore, it was not used in this group. The questionnaire consists of 29 bimanual activities, typically requiring the use of both hands. It assesses the child's experience using their affected hand when performing the activities and counts how many of the activities are executed independently (with and without using the affected hand).
In the mini-version of the CHEQ some items were deleted or replaced (with more age-appropriate activities for children aged three to eight years) and this version was used for all unilateral cerebral palsy children <six years in this study.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal brachial plexus palsy | 25 patients will be included. The level of the brachial plexus lesion will be recorded. Parents of all patients were asked to fill in the Turkish version of the "Hand-at-Home Questionnaire" and in addition, the upper extremity section of the Pediatric Outcomes Data Collection Instrument (PODCI) in patients with OBP. Receives: Behavioral: Hand-Use-at-Home Questionnaire (HUH); Behavioral: Pediatric Outcome Data Collection Instrument (PODCI) | |
| Unilateral cerebral palsy | 25 patients will be included. The level of "Manual Ability Classification System (MACS)" will be recorded. Parents of all patients were asked to fill out the Turkish version of the "Hand-at-Home Questionnaire at Home", as well as the "Children's Hand-Use Experience Questionnaire (CHEQ)" in patients with CP. Receives: Behavioral: Hand-Use-at-Home Questionnaire (HUH); Behavioral: Children's Hand-Use Experience Questionnaire (CHEQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand-Use-at-Home Questionnaire
The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/often = score 1, always = score 2).
Measured: Day 0
Hand-Use-at-Home Questionnaire (HUH)
The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/often = score 1, always = score 2).
Measured: Day 7
Secondary outcomes (2)
Pediatric Outcome Data Collection Instrument (PODCI)
The PODCI is designed to assess different aspects of daily living in children with musculoskeletal disorders. It has excellent psychometric properties, and it is a widely accepted instrument to provide parent/patient-reported information about upper extremity functioning. It consists of 85 questions and five scale scores and one total score can be calculated (range for all scales and total score 0-100, higher scores indicating better functioning/quality of life). Only the Upper Extremity and Physical Function Scale (8 items) was used in this study since this scale provides information about difficulties performing activities using the arms/hands (score 0-100; lower score, more difficulties).
Measured: Day 0
Children's Hand-Use Experience Questionnaire (CHEQ/mini-CHEQ)
The CHEQ is a questionnaire for children (aged 6-18) with unilateral functional limitations of hand use and is well validated for children with unilateral cerebral palsy. The questionnaire consists of 29 bimanual activities, typically requiring the use of both hands. It assesses the child's experience using their affected hand when performing the activities and counts how many of the activities are executed independently (with and without using the affected hand).
In the mini-version of the CHEQ some items were deleted or replaced (with more age-appropriate activities for children aged three to eight years) and this version was used for all unilateral cerebral palsy children <six years in this study.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Feb 2020
- Primary completion24 Jan 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naime Evrim Karadag Saygi, Prof, Study director, Department of PM&R, Marmara University School of MedicineAyca Evkaya, Res. Asst., Principal investigator, Department of Physiotherapy and Rehabilitation, Maltepe UniversityAyse Simsek, PT (MSc), Principal investigator, Department of Physiotherapy and Rehabilitation, Gazi University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243590
- Sponsor's protocol ID
- 09.2018.712
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
PubMed 23346889Andersen J, Watt J, Olson J, Van Aerde J. Perinatal brachial plexus palsy. Paediatr Child Health. 2006 Feb;11(2):93-100. doi: 10.1093/pch/11.2.93.
PubMed 19030261Brandao M, Ocarino JM, Bueno KM, Mancini MC. Hand use at home and in clinical settings by children with cerebral palsy: a qualitative study. Occup Ther Int. 2015 Mar;22(1):43-50. doi: 10.1002/oti.1383. Epub 2014 Oct 29.
PubMed 25354327van der Holst M, Geerdink Y, Aarts P, Steenbeek D, Pondaag W, Nelissen RG, Geurts AC, Vliet Vlieland TP. Hand-Use-at-Home Questionnaire: validity and reliability in children with neonatal brachial plexus palsy or unilateral cerebral palsy. Clin Rehabil. 2018 Oct;32(10):1363-1373. doi: 10.1177/0269215518775156. Epub 2018 May 13.
PubMed 29756465Evkaya-Acar A, Karadag-Saygi E, Yildiz A, Karali-Bingul D, Elbasan B. Validity and reliability of the Turkish version of the hand-use-at-home questionnaire for children with unilateral cerebral palsy and neonatal brachial plexus palsy. Disabil Rehabil. 2024 Aug;46(16):3702-3708. doi: 10.1080/09638288.2023.2248885. Epub 2023 Aug 24.
PubMed 37615356
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of Hand-Use-at-Home Questionnaire in Children With Neonatal Brachial Plexus Palsy or Unilateral Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT04243590
- Acronym / sponsor ID
- 09.2018.712
- Conditions
- Cerebral Palsy, Brachial Plexus Palsy
- Keywords
- brachial plexus, unilateral cerebral palsy, hand function, child rehabilitation, upper extremity, hand use at home questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 24 Jan 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 28 Jan 2020 (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.
To investigate the validity and reliability of the Turkish Version of parent-rated Hand-Use-at- Home questionnaire (HUH) in children with neonatal brachial plexus palsy or unilateral cerebral palsy.
Detailed description
Cerebral Palsy (CP) is defined as a permanent but non-progressive disorder group that affects the developing fetal or infantile brain, leading to impairment in movement and posture, thereby limiting physical activity and participation. The prevalence of CP in society is around 0.21%. In a study conducted in Turkey, this ratio of 4.4 / 1000 live births has been reported. Motor disorders in CP often are accompanied by sensory, perceptual, cognitive, communicative and behavioral problems and secondary musculoskeletal problems.
Obstetric brachial plexus (OBP) injury is a common peripheral nerve injury in children. Its incidence is reported between 0.42 and 5.1 per 1000 live births. As the primary mechanism of injury, it is accepted that traction or compression of all or part of the brachial plexus.
In these patients, weakness in the upper extremity, long-term contractures, and difficulties in the use of the extremities occurs due to the damage of nerves. In both diseases, patients have difficulty in bimanual activities.
Many treatment methods focus on increasing the use of upper extremities of patients and ensuring their independence in daily life activities. There are many methods for evaluating the hand use performance of patients and the effectiveness of different treatment methods. However, these clinical evaluation methods often do not reflect the patient's performance at home, at school, in their daily living environments.
The "Hand Use at Home (HUH)" questionnaire, which was created to be evaluated by parents, was developed in 2017 for measuring and evaluating the spontaneous use time of unilateral paretic children aged 3-10 in the affected hand and arm daily life activities.
The validity and reliability of the questionnaire were determined in children with obstetric brachial plexus paralysis and unilateral SP.
The purpose of this study; The translation of the HUH questionnaire into Turkish is to investigate its cultural adaptation, validity, and test-retest reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonatal brachial plexus palsy | – | Behavioral: Hand-Use-at-Home Questionnaire (HUH), Behavioral: Pediatric Outcome Data Collection Instrument (PODCI)25 patients will be included. The level of the brachial plexus lesion will be recorded. Parents of all patients were asked to fill in the Turkish version of the "Hand-at-Home Questionnaire" and in addition, the upper extremity section of the Pediatric Outcomes Data Collection Instrument (PODCI) in patients with OBP. |
| Unilateral cerebral palsy | – | Behavioral: Hand-Use-at-Home Questionnaire (HUH), Behavioral: Children's Hand-Use Experience Questionnaire (CHEQ)25 patients will be included. The level of "Manual Ability Classification System (MACS)" will be recorded. Parents of all patients were asked to fill out the Turkish version of the "Hand-at-Home Questionnaire at Home", as well as the "Children's Hand-Use Experience Questionnaire (CHEQ)" in patients with CP. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 42 unilateral cerebral palsy patients and 25 brachial plexus palsy between 3 - 10 years of age.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of unilateral cerebral palsy or obstetric brachial plexus palsy
- Age between 3 - 10
- Volunteer to study
Key exclusion criteria (3 listed)
- Having a visual disorder
- History of botulinum toxin injection and surgery for upper extremity and hand in the last 6 months.
- Having robotic rehabilitation or intensive treatments such as constraint-induced movement therapy to increase upper extremity use in the last 6 months.
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 |
|---|---|---|
| Hand-Use-at-Home Questionnaire (HUH)The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/ often = score 1, always = score 2). A sum score can be calculated (range 0-36). | Behavioural | Neonatal brachial plexus palsy, Unilateral cerebral palsy |
| Pediatric Outcome Data Collection Instrument (PODCI)The PODCI is designed to assess different aspects of daily living in children with musculoskeletal disorders. It has excellent psychometric properties, and it is a widely accepted instrument to provide parent/patient-reported information about upper extremity functioning. A Dutch version is available and it is validated for children with neonatal brachial plexus palsy. It consists of 85 questions and five scale scores and one total score can be calculated (range for all scales and total score 0-100, higher scores indicating better functioning/quality of life). Only the Upper Extremity and Physical Function Scale (8 items) were used in this study since this scale provides information about difficulties performing activities using the arms/hands (score 0-100; lower score, more difficulties). | Behavioural | Neonatal brachial plexus palsy |
| Children's Hand-Use Experience Questionnaire (CHEQ)The CHEQ is a questionnaire for children (aged 6-18) with unilateral functional limitations of hand use and is well validated for children with unilateral cerebral palsy. It was only partially validated for use in children with neonatal brachial plexus palsy and has not yet been used in studies. Therefore, it was not used in this group. The questionnaire consists of 29 bimanual activities, typically requiring the use of both hands. It assesses the child's experience using their affected hand when performing the activities and counts how many of the activities are executed independently (with and without using the affected hand). In the mini-version of the CHEQ some items were deleted or replaced (with more age-appropriate activities for children aged three to eight years) and this version was used for all unilateral cerebral palsy children <six years in this study. | Behavioural | Unilateral cerebral palsy |
Primary outcome
Hand-Use-at-Home Questionnaire
Time frame: Day 0
The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/often = score 1, always = score 2).
Hand-Use-at-Home Questionnaire (HUH)
Time frame: Day 7
The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/often = score 1, always = score 2).
2 secondary outcomes
Pediatric Outcome Data Collection Instrument (PODCI)
Time frame: Day 0
Children's Hand-Use Experience Questionnaire (CHEQ/mini-CHEQ)
Time frame: Day 0
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 1 Mar 2023.
- Results publication: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Results publication: PubMed 23346889Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
- Results publication: PubMed 19030261Andersen J, Watt J, Olson J, Van Aerde J. Perinatal brachial plexus palsy. Paediatr Child Health. 2006 Feb;11(2):93-100. doi: 10.1093/pch/11.2.93.
- Results publication: PubMed 25354327Brandao M, Ocarino JM, Bueno KM, Mancini MC. Hand use at home and in clinical settings by children with cerebral palsy: a qualitative study. Occup Ther Int. 2015 Mar;22(1):43-50. doi: 10.1002/oti.1383. Epub 2014 Oct 29.
- Results publication: PubMed 29756465van der Holst M, Geerdink Y, Aarts P, Steenbeek D, Pondaag W, Nelissen RG, Geurts AC, Vliet Vlieland TP. Hand-Use-at-Home Questionnaire: validity and reliability in children with neonatal brachial plexus palsy or unilateral cerebral palsy. Clin Rehabil. 2018 Oct;32(10):1363-1373. doi: 10.1177/0269215518775156. Epub 2018 May 13.
- Derived from this study: PubMed 37615356Evkaya-Acar A, Karadag-Saygi E, Yildiz A, Karali-Bingul D, Elbasan B. Validity and reliability of the Turkish version of the hand-use-at-home questionnaire for children with unilateral cerebral palsy and neonatal brachial plexus palsy. Disabil Rehabil. 2024 Aug;46(16):3702-3708. doi: 10.1080/09638288.2023.2248885. Epub 2023 Aug 24.
- Individual participant dataSharing planned: Undecided
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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.
Naime Evrim Karadag Saygi, Prof study director
Department of PM&R, Marmara University School of Medicine
Ayca Evkaya, Res. Asst. principal investigator
Department of Physiotherapy and Rehabilitation, Maltepe University
Ayse Simsek, PT (MSc) principal investigator
Department of Physiotherapy and Rehabilitation, Gazi University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Brachial Plexus Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 1 Mar 2023. 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 Turkey (Türkiye). 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?
Hand-Use-at-Home Questionnaire (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243590, which also lists 6 linked publications.
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 1 Mar 2023.