Unilateral Cerebral PalsyMuSSAPNCT05533476
Multi Sensory Stimulation And Priming (MuSSAP) in Infants at Risk of Unilateral Cerebral Palsy
A study testing Multi Sensory Stimulation and Priming in people with Unilateral Cerebral Palsy, run by Sint Maartenskliniek.
Trial summary
A pilot randomized clinical trial exploring the effect of a Multi Sensory Stimulation And Priming (MuSSAP) training on improving manual ability in infants at risk of developing unilateral Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 4 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Cerebral Palsy
- What is being tested?
- Multi Sensory Stimulation and Priming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2016to 20 Aug 2018
- 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 4 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born preterm suffering from unilateral periventricular haemorrhagic infarction with involvement of the corticospinal tracts
- Born term suffering from unilateral middle cerebral artery stroke with involvement of the corticospinal tracts
- ±4 months of age (time the infant starts to reach with at least one hand) to 10 months of age (age corrected in case of prematurity)
- Born term (≥37 weeks gestational age)
- Birth weight within a normal range (≥2500 grams)
Who cannot join
- Severe epilepsy
- Severe sensory impairments (blindness, deafness)
- Children with clinical signs of bilateral involvement
- Inability of parents to respond to interviews or questionnaires in Dutch
- Expected inability of parents to adhere to the home-based protocol
- Inability of parents to respond to interviews or questionnaires in Dutch
- Expected inability of parents to adhere to planned measuring moments
About this study
Official title: Multi Sensory Stimulation And Priming (MuSSAP) in Infants (4-12 Months of Age) at Risk of Developing Unilateral Cerebral Palsy (uCP)
A pilot randomized clinical trial exploring the effect of a Multi Sensory Stimulation And Priming (MuSSAP) training on improving manual ability in infants at risk of developing unilateral Cerebral Palsy.
Read the detailed description
Rationale:
Unilateral Cerebral Palsy (uCP) results from early brain damage. In adults, brain damage in one side of the (pre) motor cortex is associated with functional problems in the contralateral side of the body and vice versa. This is related to extensive crossings of the descending corticospinal tracts connecting the central motor systems with the musculature of the extremities. However, during the first years of our lives, crossings of the corticospinal tracts are less defined and the motor system relies on both ipsi- and contralateral connections to control the extremities. In children with uCP the classical development and strengthening of the crossed connections of the corticospinal tracts might be hampered. Although reorganization with ipsilateral corticospinal tracts can mediate useful hand function, patients with the most favourable functional outcome retain crossed projections from the affected hemisphere. To facilitate maturation of the corticospinal tracts, it seems crucial to start early with intervention at the stage that the corticospinal tracts show high plasticity. Attention benefits from multisensory congruent signals, particularly if this congruency involves rhythmical similarity. Attention influences the sensitivity of neurons to detect sensory activity and the ability of neurons to detect sensory stimulation. Formation of neural pathways is facilitated by increasing activity in (new) functional neural circuits. During the multisensory stimulation, motor actions of both or one arm and hand will be provoked. In contrast to the functional training focused primarily on motor output, MuSSAP enhances motor learning by stimulating the perception-action loop. In this study, we propose to pilot test whether a new intervention; Multi Sensory Stimulation And Priming (MuSSAP) can be applied in clinical practice in infants 4-12 months of age with diagnosed unilateral cerebral damage having increased risk on the development of unilateral cerebral palsy.
Objective:
Primary objective: The following hypothesis will be tested: MuSSAP in infants 4-12 months of age with diagnosed unilateral cerebral damage, is a feasible protocol and results in an enhanced motor development as compared to Intensive Usual Care (Upper Limb).
Secondary Objective(s): Assessment of feasibility of the intervention: Can the MuSSAP intervention and procedures be successfully executed and delivered to the participants? Assessment of acceptability: Suitability of the intervention and the study procedures from the perspective of the participants. Determining effect sizes for a future full-scale randomized clinical trial and clinical relevance.
Study design:
The study is designed as a pilot randomized clinical trial (RCT) with three measuring moments (before intervention, after intervention, and follow-up).
Study population:
The study population consists of 16 infants at risk for developing unilateral cerebral palsy. These infants will either be born preterm suffering from unilateral periventricular haemorrhagic infarction, or born at term suffering from unilateral middle cerebral artery (MCA) stroke. The infants at risk will be allocated either to the MuSSAP intervention group (8 infants) or the Intensive Usual Care (Upper Limb) group (8 infants) by randomisation. Data of 8 typically developing infants will be used to monitor typical development of infants of 4-12 months old.
Intervention:
Both the MuSSAP and the Intensive Usual Care (Upper Limb) interventions are home based and consist of 30 minutes (divided in 3 periods of 10 minutes each) of remediating impairments practicing specific age related movements and skills, each day for an 8-week period, conducted by the parents and once a week by a physical or occupational therapist in the home environment. Upper extremity motor activities like reaching, grasping and holding are practiced. Coaching of parents and therapists will be performed by the occupational therapist of the Sint Maartenskliniek. This will be realised through analysing video recordings of the intervention in the home environment once a week.
Multi Sensory Stimulation And Priming (MuSSAP): In the MuSSAP intervention a custom made wristband will be used to provide rhythmical congruent multisensory stimulations to the affected arm and hand aiming to increase attention for the affected upper limb. Subsequently, motor actions of the affected arm and hand will be provoked.
Intensive Usual Care (Upper Limb): This intervention is a more intensive (in duration and frequency) version of standard Usual Care with focus on the motor development of the affected upper extremity.
In both intervention groups infants will additionally receive pediatric physical therapy in the home environment (usual care) focusing on gross motor development.
Primary study parameters/outcome of the study:
The primary study parameter aims at development of handfunction/ manual ability (measured with the Hand Assessment for Infants (HAI)).
- Conditions
- Unilateral Cerebral Palsy
- Being tested
- Multi Sensory Stimulation and Priming, Intensive Usual Care (Upper Limb)
- Keywords
- Cerebral Palsy, Multisensory Stimulation, Hand function, Infants, Early intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi Sensory Stimulation and PrimingBehavioural
In the MuSSAP intervention group, the infant wears a multisensory stimulating wristband aiming at increasing attention for the affected upper limb and readiness to initiate a goal-directed movement. Parents are instructed to present a toy to their child if the child shows attention to the affected arm and hand. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training.
Intensive Usual Care (Upper Limb)Behavioural
The Intensive Usual Care (Upper Limb) intervention is a more intensive (in duration and frequency) version of standard Usual Care with focus on the motor development of the affected upper extremity. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training.
| Study group | Role | What they receive |
|---|---|---|
| Multi Sensory Stimulation And Priming | Experimental | 8 weeks, 30 minutes per day home based MuSSAP training. Receives: Behavioral: Multi Sensory Stimulation and Priming |
| Intensive Usual Care (Upper Limb) | Experimental | 8 weeks, 30 minutes per day home based Intensive Usual Care (Upper Limb). Receives: Behavioral: Intensive Usual Care (Upper Limb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from T0 in manual ability as assessed by the Hand Assessment for Infants (HAI)
The HAI is intended to evaluate the quality of goal-directed manual actions in infants, 3-12 months of age, at risk of developing unilateral CP. The test procedure comprises a semi-structured video-recorded 10-15-min play session. HAI is intended to detect and quantify possible asymmetry between hands by providing scores for each hand separately (Each Hand sum Score (EaHS) (range 0-24)), and to provide a measure of bilateral hand use (Both Hands Measure (BoHM) (range 0-100)) with a higher score reflecting a better outcome.
Measured: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
Adherence based on total training time
Parents fill out a digital time registration form to assess intervention adherence every day. Adherence will be calculated by dividing the registrated total training time by total planned training time (28 hours).
Measured: During 8 week intervention
Secondary outcomes (4)
Motor development as assessed by the Bayley Scales of Infant and Toddler Development - Third Edition (Dutch version) (Bayley-III-NL)
The motor scale of the Bayley-III-NL will be used to assess motor development. The gross motor (GM) subscale raw scores (range 0-72) will be determined on all assessment points, the fine motor (FM) subscale raw scores (range 0-66) on T0 only. A higher score reflects a better outcome.
Measured: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
Gross motor development as assessed by the Gross Motor Function Measure (GMFM)
The GMFM contains eighty-eight items grouped into five dimensions (e.g. lying and rolling, sitting, crawling and kneeling, standing, walking, running and jumping) and is sensitive to motor developmental changes over time.
Measured: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
Quality of life as assessed by the Infant and Toddler Quality of life Questionnaire (ITQOL)
The infant/toddler quality of life questionnaire (ITQOL) is a generic parent-completed 'profile-measure' for health status and health-related quality of life of children between 2 months and 5 years old. Raw scale scores are transformed to a standardized 0-100 continuum with a higher score reflecting a better health status.
Measured: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
Reaction time of self-initiated goal-directed movement and attention as assessed by the Video Observation Attention Affected Hand (VOAAH)
The VOAAH is a video-observation tool that is used to assess time to self-initiated goal-directed movement and time to attention. Training session videos recorded by parents are manually scored using a standardized protocol.
Measured: During 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start14 Jun 2016
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unilateral 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Aarts, PhD, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533476
- Sponsor's protocol ID
- 724
- Other IDs
- NL52823.091.15
- Acronym
- MuSSAP
- Status last verified
- Oct 2022
- First submitted
- 5 Sep 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verhaegh AP, Nuijen NB, Aarts PB, Nijhuis-van der Sanden MWG, Willemsen MA, Groen BE, Vriezekolk JE. Parents' experiences with a home-based upper limb training program using a video coaching approach for infants and toddlers with unilateral cerebral palsy: a qualitative interview study. BMC Pediatr. 2022 Jun 29;22(1):380. doi: 10.1186/s12887-022-03432-w.
PubMed 35768858Verhaegh APM, Groen BE, Aarts PBM, van Ee R, Willemsen MAAP, Jongsma MLA, Nijhuis-van der Sanden MWG. Multisensory Stimulation and Priming (MuSSAP) in 4-10 Months Old Infants with a Unilateral Brain Lesion: A Pilot Randomised Clinical Trial. Occup Ther Int. 2023 Jan 6;2023:8128407. doi: 10.1155/2023/8128407. eCollection 2023.
PubMed 36711188
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Sensory Stimulation And Priming (MuSSAP) in Infants (4-12 Months of Age) at Risk of Developing Unilateral Cerebral Palsy (uCP)
- ClinicalTrials.gov ID
- NCT05533476
- Acronym / sponsor ID
- MuSSAP / 724
- Conditions
- Unilateral Cerebral Palsy
- Keywords
- Cerebral Palsy, Multisensory Stimulation, Hand function, Infants, Early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 9 Sep 2022 (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.
A pilot randomized clinical trial exploring the effect of a Multi Sensory Stimulation And Priming (MuSSAP) training on improving manual ability in infants at risk of developing unilateral Cerebral Palsy.
Detailed description
Rationale:
Unilateral Cerebral Palsy (uCP) results from early brain damage. In adults, brain damage in one side of the (pre) motor cortex is associated with functional problems in the contralateral side of the body and vice versa. This is related to extensive crossings of the descending corticospinal tracts connecting the central motor systems with the musculature of the extremities. However, during the first years of our lives, crossings of the corticospinal tracts are less defined and the motor system relies on both ipsi- and contralateral connections to control the extremities. In children with uCP the classical development and strengthening of the crossed connections of the corticospinal tracts might be hampered. Although reorganization with ipsilateral corticospinal tracts can mediate useful hand function, patients with the most favourable functional outcome retain crossed projections from the affected hemisphere. To facilitate maturation of the corticospinal tracts, it seems crucial to start early with intervention at the stage that the corticospinal tracts show high plasticity. Attention benefits from multisensory congruent signals, particularly if this congruency involves rhythmical similarity. Attention influences the sensitivity of neurons to detect sensory activity and the ability of neurons to detect sensory stimulation. Formation of neural pathways is facilitated by increasing activity in (new) functional neural circuits. During the multisensory stimulation, motor actions of both or one arm and hand will be provoked. In contrast to the functional training focused primarily on motor output, MuSSAP enhances motor learning by stimulating the perception-action loop. In this study, we propose to pilot test whether a new intervention; Multi Sensory Stimulation And Priming (MuSSAP) can be applied in clinical practice in infants 4-12 months of age with diagnosed unilateral cerebral damage having increased risk on the development of unilateral cerebral palsy.
Objective:
Primary objective: The following hypothesis will be tested: MuSSAP in infants 4-12 months of age with diagnosed unilateral cerebral damage, is a feasible protocol and results in an enhanced motor development as compared to Intensive Usual Care (Upper Limb).
Secondary Objective(s): Assessment of feasibility of the intervention: Can the MuSSAP intervention and procedures be successfully executed and delivered to the participants? Assessment of acceptability: Suitability of the intervention and the study procedures from the perspective of the participants. Determining effect sizes for a future full-scale randomized clinical trial and clinical relevance.
Study design:
The study is designed as a pilot randomized clinical trial (RCT) with three measuring moments (before intervention, after intervention, and follow-up).
Study population:
The study population consists of 16 infants at risk for developing unilateral cerebral palsy. These infants will either be born preterm suffering from unilateral periventricular haemorrhagic infarction, or born at term suffering from unilateral middle cerebral artery (MCA) stroke. The infants at risk will be allocated either to the MuSSAP intervention group (8 infants) or the Intensive Usual Care (Upper Limb) group (8 infants) by randomisation. Data of 8 typically developing infants will be used to monitor typical development of infants of 4-12 months old.
Intervention:
Both the MuSSAP and the Intensive Usual Care (Upper Limb) interventions are home based and consist of 30 minutes (divided in 3 periods of 10 minutes each) of remediating impairments practicing specific age related movements and skills, each day for an 8-week period, conducted by the parents and once a week by a physical or occupational therapist in the home environment. Upper extremity motor activities like reaching, grasping and holding are practiced. Coaching of parents and therapists will be performed by the occupational therapist of the Sint Maartenskliniek. This will be realised through analysing video recordings of the intervention in the home environment once a week.
Multi Sensory Stimulation And Priming (MuSSAP): In the MuSSAP intervention a custom made wristband will be used to provide rhythmical congruent multisensory stimulations to the affected arm and hand aiming to increase attention for the affected upper limb. Subsequently, motor actions of the affected arm and hand will be provoked.
Intensive Usual Care (Upper Limb): This intervention is a more intensive (in duration and frequency) version of standard Usual Care with focus on the motor development of the affected upper extremity.
In both intervention groups infants will additionally receive pediatric physical therapy in the home environment (usual care) focusing on gross motor development.
Primary study parameters/outcome of the study:
The primary study parameter aims at development of handfunction/ manual ability (measured with the Hand Assessment for Infants (HAI)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi Sensory Stimulation And Priming | Experimental | Behavioral: Multi Sensory Stimulation and Priming8 weeks, 30 minutes per day home based MuSSAP training. |
| Intensive Usual Care (Upper Limb) | Experimental | Behavioral: Intensive Usual Care (Upper Limb)8 weeks, 30 minutes per day home based Intensive Usual Care (Upper Limb). |
Who may qualify
- Ages
- 4 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Born preterm suffering from unilateral periventricular haemorrhagic infarction with involvement of the corticospinal tracts
- Born term suffering from unilateral middle cerebral artery stroke with involvement of the corticospinal tracts
- ±4 months of age (time the infant starts to reach with at least one hand) to 10 months of age (age corrected in case of prematurity)
- Born term (≥37 weeks gestational age)
- Birth weight within a normal range (≥2500 grams)
Key exclusion criteria (7 listed)
- Severe epilepsy
- Severe sensory impairments (blindness, deafness)
- Children with clinical signs of bilateral involvement
- Inability of parents to respond to interviews or questionnaires in Dutch
- Expected inability of parents to adhere to the home-based protocol
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 |
|---|---|---|
| Multi Sensory Stimulation and PrimingIn the MuSSAP intervention group, the infant wears a multisensory stimulating wristband aiming at increasing attention for the affected upper limb and readiness to initiate a goal-directed movement. Parents are instructed to present a toy to their child if the child shows attention to the affected arm and hand. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training. | Behavioural | Multi Sensory Stimulation And Priming |
| Intensive Usual Care (Upper Limb)The Intensive Usual Care (Upper Limb) intervention is a more intensive (in duration and frequency) version of standard Usual Care with focus on the motor development of the affected upper extremity. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training. | Behavioural | Intensive Usual Care (Upper Limb) |
Primary outcome
Mean change from T0 in manual ability as assessed by the Hand Assessment for Infants (HAI)
Time frame: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
The HAI is intended to evaluate the quality of goal-directed manual actions in infants, 3-12 months of age, at risk of developing unilateral CP. The test procedure comprises a semi-structured video-recorded 10-15-min play session. HAI is intended to detect and quantify possible asymmetry between hands by providing scores for each hand separately (Each Hand sum Score (EaHS) (range 0-24)), and to provide a measure of bilateral hand use (Both Hands Measure (BoHM) (range 0-100)) with a higher score reflecting a better outcome.
Adherence based on total training time
Time frame: During 8 week intervention
Parents fill out a digital time registration form to assess intervention adherence every day. Adherence will be calculated by dividing the registrated total training time by total planned training time (28 hours).
4 secondary outcomes
Motor development as assessed by the Bayley Scales of Infant and Toddler Development - Third Edition (Dutch version) (Bayley-III-NL)
Time frame: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
Gross motor development as assessed by the Gross Motor Function Measure (GMFM)
Time frame: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
Quality of life as assessed by the Infant and Toddler Quality of life Questionnaire (ITQOL)
Time frame: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)
Reaction time of self-initiated goal-directed movement and attention as assessed by the Video Observation Attention Affected Hand (VOAAH)
Time frame: During 8 week intervention
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 31 Oct 2022.
- Background: PubMed 35768858Verhaegh AP, Nuijen NB, Aarts PB, Nijhuis-van der Sanden MWG, Willemsen MA, Groen BE, Vriezekolk JE. Parents' experiences with a home-based upper limb training program using a video coaching approach for infants and toddlers with unilateral cerebral palsy: a qualitative interview study. BMC Pediatr. 2022 Jun 29;22(1):380. doi: 10.1186/s12887-022-03432-w.
- Derived from this study: PubMed 36711188Verhaegh APM, Groen BE, Aarts PBM, van Ee R, Willemsen MAAP, Jongsma MLA, Nijhuis-van der Sanden MWG. Multisensory Stimulation and Priming (MuSSAP) in 4-10 Months Old Infants with a Unilateral Brain Lesion: A Pilot Randomised Clinical Trial. Occup Ther Int. 2023 Jan 6;2023:8128407. doi: 10.1155/2023/8128407. eCollection 2023.
- Medical Ethical Registration and Reviewing formLink provided by the sponsor.
- Website information infant and toddler upper limb rehabilitation programs Sint MaartenskliniekLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pauline Aarts, PhD principal investigator
Sint Maartenskliniek
Questions about this trial
What is this clinical trial studying?
A study testing Multi Sensory Stimulation and Priming in people with Unilateral Cerebral Palsy, run by Sint Maartenskliniek.
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 5 inclusion and 7 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean change from T0 in manual ability as assessed by the Hand Assessment for Infants (HAI) (time frame: T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)). 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 NCT05533476, which also lists 2 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 31 Oct 2022.