Cerebral PalsySERIOUSGAMENCT03353623
Immersive Virtual Environments and Wearable Haptic Devices in Rehabilitation of Children With Neuromotor Impairments
A study testing Serious Game and Conventional Therapy in people with Cerebral Palsy and Dyspraxia, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 1 site in Italy.
Trial summary
The investigators proposed a controlled, single-blind, unicentric, crossover, randomized, clinical trial to test the effects of immersive virtual environments and wearable haptic devices in the rehabilitation of children with neuromotor impairments. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Dyspraxia
- What is being tested?
- Serious Game and Conventional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2017to 9 Oct 2017
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a history of neuromotor disorders (CP or DD)
- a maximum age of 18 years
- a minimum ability to actively grasp an object
- the ability to understand simple instructions
- low to severe impairments of the upper limbs
Who cannot join
- epileptic patients
- severe deficit in sensory perception of upper limb
- severe visual impairments
- severe cognitive diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital
Pisa, PI, 56100
About this study
Official title: A Randomized Controlled Single-Blind Crossover Trial on the Effects of Serious Games and Wearable Haptic Devices in the Rehabilitation of Children With Neuromotor Impairments
The investigators proposed a controlled, single-blind, unicentric, crossover, randomized, clinical trial to test the effects of immersive virtual environments and wearable haptic devices in the rehabilitation of children with neuromotor impairments. In addition, the proposed approach was compared with respect to conventional therapy.
A sample of 8 participants was randomly divided into 2 groups and they attended one of the two therapeutic approach for 4 weeks before crossing over and inverting the therapy. Between the two interventions, there was a wash out period of 4 weeks.
The investigators assessed motor abilities of the children with validated clinical scales and motion analysis before/after each phase of the study (T0: baseline, T1: after 4 weeks, T2: after 8 weeks, T3: after 16 weeks, and T4: up to 24 weeks).
Read the detailed description
A Randomized Controlled Crossover Trial was designed to examine the usability and effectiveness of serious games and wearable haptic interfaces in rehabilitation of children with neuromotor impairments. The ethics board of Tuscany Region and the Italian Ministry of Health approved this study. All parents freely accepted the participation of their children in the study and provided written informed consent.
The investigators recruited eight patients, both male and female, 3 children with Cerebral Palsy (CP) and 5 children with Developmental Dyspraxia (DD) (mean age = 10,30±2,88 years), who were currently receiving conventional therapy at Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, and eight Typically Developing children (TD, mean age = 9,60±2,61 years). All the patients were right-handed and they did not have previous experiences with Virtual Reality (VR) and/or haptic devices, while TD children have previously experienced with commercial video games.
Following recruitment, screening and consent and baseline assessments, participants are randomized to an order of VR-assisted rehabilitation (ISG-Group, Immediate Serious Games, or DSG-Group, Delayed Serious Games). Participants were setup in their first condition and were assessed at the end of the 4 week intervention. Participants were then set up in their second period for 4 weeks, again with assessment occurring at the end of the intervention. Among the two interventions, a wash out period of 4 weeks was inserted and children followed only cognitive therapy with no physical sessions.
The study protocol consisted of a total of 16 sessions with both VR-assisted and conventional rehabilitation (2 sessions per week for 4 weeks for 2 periods) and involved a familiarization and a training phase. The investigators adopted different established clinical scales for children with CP and DD in order to assess patients' abilities during the assessments. The investigators also selected metrics obtained from end-point (hand) kinematic data, including movement speed and accuracy, in order to have quantitative measurements of patients' motor abilities.
- Conditions
- Cerebral Palsy, Dyspraxia
- Being tested
- Serious Game, Conventional Therapy
- Keywords
- Immersive Virtual Environments, Wearable Haptic Devices, Neuromotor Impairments, Rehabilitation, Serious Game, Randomized Controlled Trial
- Medical subject headings
- Cerebral Palsy, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious GameDevice
Serious Game (SG) refers to the use of immersive virtual environments and wearable haptic devices during the treatment. Two SG were specifically developed to allow a playful training of different, targeted Upper Limb (UL) movement based on typical rehabilitation exercises (reach-to-grasp, linear path tracking, hand orientation). The child interacts directly with a virtual environment through haptic feedback provided to his/her fingertips. In particular, "moneybox game" focused on pincer grasp and reaching tasks with pronation/supination od the hand while "marble labyrinth game" focused on pointing and tracking movements requiring both eye-hand and upper limb inter-joint coordination.
Conventional TherapyOther
Conventional therapy (CONV) refers to the neurocognitive rehabilitation approach, with the purpose of improving pointing, tracking, reaching and grasping, and pronation/supination of the forearm. The therapeutic sessions were performed with the exception of the visual channel to ensure that the child focused his/her attention on tactile/kinesthetic information to complete the task. In particular, five different tasks have been proposed during the sessions: 1) recognize trajectories; 2) arm proprioception; 3) object manipulation; 4) recognize surfaces; 5) forearm orientation.
| Study group | Role | What they receive |
|---|---|---|
| ISG-Group (Immediate Serious Game) | Experimental | Children in the ISG-Group first participated in the VR-assisted rehabilitation, which consisted in 8 sessions with immersive virtual environment and wearable haptic devices, and were then crossed over and followed during an intended duration of 6 hours of conventional therapy. Receives: Device: Serious Game; Other: Conventional Therapy |
| DSG-Group (Delayed Serious Game) | Experimental | Children from DSG-Group were followed during an intended duration of 6 hours of conventional therapy before receiving VR-assisted rehabilitation with immersive virtual environment and wearable haptic devices. Receives: Device: Serious Game; Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Time Scores on Nine Hole Peg Test (9-HPT) for both Dominant and Non-Dominant Hands at 4, 8, 16 and 24 weeks
Nine Hole Peg Test (9-HPT) is a brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The child is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the child picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded.
Measured: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
Change From Baseline in Kinematic Metrics on Linear Path Tracking (LPT) and Reach-to-Grasp (RtG) Tasks for Dominant Hand at 4, 8, 16 and 24 weeks
The evaluation task consisted of two reach-to-grasp tasks requiring forearm pronation or supination and three linear path tracking (forward and sideways). For the RtG task, the child was asked to flip a card protruding from an horizontal support. For the LPT, the child was seated in front of a desk with the hand positioned, at rest, close to the body on the sagittal plane. Then a target was put on the desk (always at the same distance from the starting position) and the child was asked to reach the target by moving the hand along a straight path. All tasks were performed with the preferred arm at self selected speed. The investigators then extracted kinematic metrics (movement speed, accuracy and smoothness) from end-point (hand) kinematic data.
Measured: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
Secondary outcomes (1)
Number of Participants with Treatment-Related Adverse Events according to the CTCAE v.4.0
The investigators referred to the following System Organ Class (SOC): Eye disorders, General disorders and administration site conditions, Nervous system disorders, Psychiatric disorders.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start13 Feb 2017
- Primary completion6 Jun 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators adopted a 2x2 crossover design (2-sequence, 2-period, 2-treatment crossover design, with sequences AB and BA): each participant received both conventional and VR-aided therapy for a period of 4 weeks per treatment (2 sessions per week of 45 minutes) assigned in a different order. A wash out period of 4 weeks was included before the second period of intervention started.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Sponsor type
- University, hospital or other
- Collaborators
- Unit of Developmental Neurorehabilitation, Pisa University Hospital
- Responsible party
- Principal investigator, Antonio Frisoli, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Investigators
- Ilaria Bortone, PhD, Study chair, PERCRO Laboratory, Scuola Superiore Sant'Anna, via L. Alamanno 13b, 56010 Ghezzano, Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353623
- Sponsor's protocol ID
- [SG]-CIV-IT-17-04-019324
- Acronym
- SERIOUSGAME
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leonardis D, Solazzi M, Bortone I, Frisoli A. A 3-RSR Haptic Wearable Device for Rendering Fingertip Contact Forces. IEEE Trans Haptics. 2017 Jul-Sep;10(3):305-316. doi: 10.1109/TOH.2016.2640291. Epub 2016 Dec 15.
PubMed 28113306Bortone I, Leonardis D, Solazzi M, Procopio C, Crecchi A, Bonfiglio L, Frisoli A. Integration of serious games and wearable haptic interfaces for Neuro Rehabilitation of children with movement disorders: A feasibility study. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:1094-1099. doi: 10.1109/ICORR.2017.8009395.
PubMed 28813967Leonardis, D., Solazzi, M., Bortone, I., & Frisoli, A. (2015, June). A wearable fingertip haptic device with 3 dof asymmetric 3-rsr kinematics. In World Haptics Conference (WHC), 2015 IEEE (pp. 388-393). IEEE.
Bortone, I., Leonardis, D., Solazzi, M., Procopio, C., Crecchi, A., Briscese, L., ... & Frisoli, A. (2017). Serious Game and Wearable Haptic Devices for Neuro Motor Rehabilitation of Children with Cerebral Palsy. In Converging Clinical and Engineering Research on Neurorehabilitation II (pp. 443-447). Springer International Publishing.
Bortone I, Barsotti M, Leonardis D, Crecchi A, Tozzini A, Bonfiglio L, Frisoli A. Immersive Virtual Environments and Wearable Haptic Devices in rehabilitation of children with neuromotor impairments: a single-blind randomized controlled crossover pilot study. J Neuroeng Rehabil. 2020 Oct 28;17(1):144. doi: 10.1186/s12984-020-00771-6.
PubMed 33115487
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Single-Blind Crossover Trial on the Effects of Serious Games and Wearable Haptic Devices in the Rehabilitation of Children With Neuromotor Impairments
- ClinicalTrials.gov ID
- NCT03353623
- Acronym / sponsor ID
- SERIOUSGAME / [SG]-CIV-IT-17-04-019324
- Conditions
- Cerebral Palsy, Dyspraxia
- Keywords
- Immersive Virtual Environments, Wearable Haptic Devices, Neuromotor Impairments, Rehabilitation, Serious Game, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'AnnaUniversity, hospital or other
- Collaborators
- Unit of Developmental Neurorehabilitation, Pisa University Hospital
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 27 Nov 2017 (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 investigators proposed a controlled, single-blind, unicentric, crossover, randomized, clinical trial to test the effects of immersive virtual environments and wearable haptic devices in the rehabilitation of children with neuromotor impairments. In addition, the proposed approach was compared with respect to conventional therapy.
A sample of 8 participants was randomly divided into 2 groups and they attended one of the two therapeutic approach for 4 weeks before crossing over and inverting the therapy. Between the two interventions, there was a wash out period of 4 weeks.
The investigators assessed motor abilities of the children with validated clinical scales and motion analysis before/after each phase of the study (T0: baseline, T1: after 4 weeks, T2: after 8 weeks, T3: after 16 weeks, and T4: up to 24 weeks).
Detailed description
A Randomized Controlled Crossover Trial was designed to examine the usability and effectiveness of serious games and wearable haptic interfaces in rehabilitation of children with neuromotor impairments. The ethics board of Tuscany Region and the Italian Ministry of Health approved this study. All parents freely accepted the participation of their children in the study and provided written informed consent.
The investigators recruited eight patients, both male and female, 3 children with Cerebral Palsy (CP) and 5 children with Developmental Dyspraxia (DD) (mean age = 10,30±2,88 years), who were currently receiving conventional therapy at Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, and eight Typically Developing children (TD, mean age = 9,60±2,61 years). All the patients were right-handed and they did not have previous experiences with Virtual Reality (VR) and/or haptic devices, while TD children have previously experienced with commercial video games.
Following recruitment, screening and consent and baseline assessments, participants are randomized to an order of VR-assisted rehabilitation (ISG-Group, Immediate Serious Games, or DSG-Group, Delayed Serious Games). Participants were setup in their first condition and were assessed at the end of the 4 week intervention. Participants were then set up in their second period for 4 weeks, again with assessment occurring at the end of the intervention. Among the two interventions, a wash out period of 4 weeks was inserted and children followed only cognitive therapy with no physical sessions.
The study protocol consisted of a total of 16 sessions with both VR-assisted and conventional rehabilitation (2 sessions per week for 4 weeks for 2 periods) and involved a familiarization and a training phase. The investigators adopted different established clinical scales for children with CP and DD in order to assess patients' abilities during the assessments. The investigators also selected metrics obtained from end-point (hand) kinematic data, including movement speed and accuracy, in order to have quantitative measurements of patients' motor abilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators adopted a 2x2 crossover design (2-sequence, 2-period, 2-treatment crossover design, with sequences AB and BA): each participant received both conventional and VR-aided therapy for a period of 4 weeks per treatment (2 sessions per week of 45 minutes) assigned in a different order. A wash out period of 4 weeks was included before the second period of intervention started.
| Arm | Type | Receives |
|---|---|---|
| ISG-Group (Immediate Serious Game) | Experimental | Device: Serious Game, Other: Conventional TherapyChildren in the ISG-Group first participated in the VR-assisted rehabilitation, which consisted in 8 sessions with immersive virtual environment and wearable haptic devices, and were then crossed over and followed during an intended duration of 6 hours of conventional therapy. |
| DSG-Group (Delayed Serious Game) | Experimental | Device: Serious Game, Other: Conventional TherapyChildren from DSG-Group were followed during an intended duration of 6 hours of conventional therapy before receiving VR-assisted rehabilitation with immersive virtual environment and wearable haptic devices. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- a history of neuromotor disorders (CP or DD)
- a maximum age of 18 years
- a minimum ability to actively grasp an object
- the ability to understand simple instructions
- low to severe impairments of the upper limbs
Key exclusion criteria (4 listed)
- epileptic patients
- severe deficit in sensory perception of upper limb
- severe visual impairments
- severe cognitive diseases
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 |
|---|---|---|
| Serious GameSerious Game (SG) refers to the use of immersive virtual environments and wearable haptic devices during the treatment. Two SG were specifically developed to allow a playful training of different, targeted Upper Limb (UL) movement based on typical rehabilitation exercises (reach-to-grasp, linear path tracking, hand orientation). The child interacts directly with a virtual environment through haptic feedback provided to his/her fingertips. In particular, "moneybox game" focused on pincer grasp and reaching tasks with pronation/supination od the hand while "marble labyrinth game" focused on pointing and tracking movements requiring both eye-hand and upper limb inter-joint coordination. | Device | DSG-Group (Delayed Serious Game), ISG-Group (Immediate Serious Game) |
| Conventional TherapyConventional therapy (CONV) refers to the neurocognitive rehabilitation approach, with the purpose of improving pointing, tracking, reaching and grasping, and pronation/supination of the forearm. The therapeutic sessions were performed with the exception of the visual channel to ensure that the child focused his/her attention on tactile/kinesthetic information to complete the task. In particular, five different tasks have been proposed during the sessions: 1) recognize trajectories; 2) arm proprioception; 3) object manipulation; 4) recognize surfaces; 5) forearm orientation. | Other | DSG-Group (Delayed Serious Game), ISG-Group (Immediate Serious Game) |
Primary outcome
Change From Baseline in Time Scores on Nine Hole Peg Test (9-HPT) for both Dominant and Non-Dominant Hands at 4, 8, 16 and 24 weeks
Time frame: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
Nine Hole Peg Test (9-HPT) is a brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The child is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the child picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded.
Change From Baseline in Kinematic Metrics on Linear Path Tracking (LPT) and Reach-to-Grasp (RtG) Tasks for Dominant Hand at 4, 8, 16 and 24 weeks
Time frame: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
The evaluation task consisted of two reach-to-grasp tasks requiring forearm pronation or supination and three linear path tracking (forward and sideways). For the RtG task, the child was asked to flip a card protruding from an horizontal support. For the LPT, the child was seated in front of a desk with the hand positioned, at rest, close to the body on the sagittal plane. Then a target was put on the desk (always at the same distance from the starting position) and the child was asked to reach the target by moving the hand along a straight path. All tasks were performed with the preferred arm at self selected speed. The investigators then extracted kinematic metrics (movement speed, accuracy and smoothness) from end-point (hand) kinematic data.
1 secondary outcome
Number of Participants with Treatment-Related Adverse Events according to the CTCAE v.4.0
Time frame: Up to 16 weeks
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 27 Nov 2017.
- Results publication: PubMed 28113306Leonardis D, Solazzi M, Bortone I, Frisoli A. A 3-RSR Haptic Wearable Device for Rendering Fingertip Contact Forces. IEEE Trans Haptics. 2017 Jul-Sep;10(3):305-316. doi: 10.1109/TOH.2016.2640291. Epub 2016 Dec 15.
- Results publication: PubMed 28813967Bortone I, Leonardis D, Solazzi M, Procopio C, Crecchi A, Bonfiglio L, Frisoli A. Integration of serious games and wearable haptic interfaces for Neuro Rehabilitation of children with movement disorders: A feasibility study. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:1094-1099. doi: 10.1109/ICORR.2017.8009395.
- Results publicationLeonardis, D., Solazzi, M., Bortone, I., & Frisoli, A. (2015, June). A wearable fingertip haptic device with 3 dof asymmetric 3-rsr kinematics. In World Haptics Conference (WHC), 2015 IEEE (pp. 388-393). IEEE.
- Results publicationBortone, I., Leonardis, D., Solazzi, M., Procopio, C., Crecchi, A., Briscese, L., ... & Frisoli, A. (2017). Serious Game and Wearable Haptic Devices for Neuro Motor Rehabilitation of Children with Cerebral Palsy. In Converging Clinical and Engineering Research on Neurorehabilitation II (pp. 443-447). Springer International Publishing.
- Derived from this study: PubMed 33115487Bortone I, Barsotti M, Leonardis D, Crecchi A, Tozzini A, Bonfiglio L, Frisoli A. Immersive Virtual Environments and Wearable Haptic Devices in rehabilitation of children with neuromotor impairments: a single-blind randomized controlled crossover pilot study. J Neuroeng Rehabil. 2020 Oct 28;17(1):144. doi: 10.1186/s12984-020-00771-6.
- This work was supported by the "Wearable Haptics for robot and humans (short: WEARHAP) project, which is funded under the framework EU FP7 project n. 601165.Link provided by the sponsor.
- 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.
Ilaria Bortone, PhD study chair
PERCRO Laboratory, Scuola Superiore Sant'Anna, via L. Alamanno 13b, 56010 Ghezzano, Pisa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious Game and Conventional Therapy in people with Cerebral Palsy and Dyspraxia, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 1 site in Italy.
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 4 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 27 Nov 2017. 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 Italy. 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?
Change From Baseline in Time Scores on Nine Hole Peg Test (9-HPT) for both Dominant and Non-Dominant Hands at 4, 8, 16 and 24 weeks (time frame: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)). 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 NCT03353623, which also lists 5 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 27 Nov 2017.