Muscular DystrophiesNCT04308447
Ablelite Pediatric Device Clinical Study
A study testing AbleLite in people with Muscular Dystrophies, run by AbiliTech Medical Inc..
Trial summary
The primary objective of the AbleLite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the Abilitech AbleLite device in the clinic and home environments. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Muscular Dystrophies
- What is being tested?
- AbleLite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Jan 2021
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects between 9 and 18 years of age, with pediatric onset of neuromuscular conditions that cause quadriparesis
- MMT score of 1-3 in the elbow, wrist and hands, and an MMT score of 2- to 3 in the shoulder
- Ability of subject to raise their forearm off of their lap or laptray
- Willingness to comply and participate with the study protocol and attend the study sessions
- Ability to communicate verbally and respond to questions and commands
- Ability to provide informed consent
- Selected for participation based on investigator discretion
Who cannot join
- Use of ventilator
- Open wounds or chronic pressure sores on upper extremities, neck, back or torso
- Significantly unstable upper extremity joints
- Unhealed bone fractures in the upper extremities
- Active rotator cuff tear, grade 2 or 3
- Surgical fixations limiting full passive range of motion
Show all 14Show fewer
- Uncontrolled upper-limb spasticity that significantly limits normal range of motion
- Uncontrollable pain in the neck, shoulders or upper limbs
- Ability to fully raise both hands simultaneously above their head with ease
- Lack passive shoulder abduction of 120 degrees
- Lack 90 degrees of passive elbow extension
- Unable to follow instructions
- Exhibit significant behavioral problems
- Inability to provide consent
Trial locations and contacts
No sites are listed yet.
About this study
The primary objective of the AbleLite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the Abilitech AbleLite device in the clinic and home environments. Functional outcomes will include documenting active range of motion and the ability to perform activities of daily living (ADLs) using the standardized Canadian Occupational Performance Measure (COPM) and the Role Evaluation of Activities of Life (REAL) assessments. Secondary objectives are to assess the safety record and report on adverse events (AEs) and parameters related to device usage, including device usage time and the time required to don/doff the device.
- Conditions
- Muscular Dystrophies
- Being tested
- AbleLite
- Medical subject headings
- Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbleLiteDevice
The AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| AbleLite | Experimental | The AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living. Receives: Device: AbleLite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Measured: Change from Baseline before device intervention (30 days), and after device intervention (60 days)
Roll Evaluation of Activities of Life (REAL) assessment
The REAL is an instrument to help professionals assess a child's ability to care for themselves at home, at school and in the community.
Measured: Change from Baseline before device intervention (30 days), and after device intervention (60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DystrophiesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbiliTech Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gillette Children's Specialty Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308447
- Sponsor's protocol ID
- PR610003-100
- Other IDs
- 2R44HD089789-02
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablelite Pediatric Device Clinical Study
- ClinicalTrials.gov ID
- NCT04308447
- Acronym / sponsor ID
- PR610003-100
- Conditions
- Muscular Dystrophies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AbiliTech Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gillette Children's Specialty Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 16 Mar 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.
The primary objective of the AbleLite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the Abilitech AbleLite device in the clinic and home environments. Functional outcomes will include documenting active range of motion and the ability to perform activities of daily living (ADLs) using the standardized Canadian Occupational Performance Measure (COPM) and the Role Evaluation of Activities of Life (REAL) assessments. Secondary objectives are to assess the safety record and report on adverse events (AEs) and parameters related to device usage, including device usage time and the time required to don/doff the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AbleLite | Experimental | Device: AbleLiteThe AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Subjects between 9 and 18 years of age, with pediatric onset of neuromuscular conditions that cause quadriparesis
- MMT score of 1-3 in the elbow, wrist and hands, and an MMT score of 2- to 3 in the shoulder
- Ability of subject to raise their forearm off of their lap or laptray
- Willingness to comply and participate with the study protocol and attend the study sessions
- Ability to communicate verbally and respond to questions and commands
Key exclusion criteria (14 listed)
- Use of ventilator
- Open wounds or chronic pressure sores on upper extremities, neck, back or torso
- Significantly unstable upper extremity joints
- Unhealed bone fractures in the upper extremities
- Active rotator cuff tear, grade 2 or 3
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 |
|---|---|---|
| AbleLiteThe AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living. | Device | AbleLite |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: Change from Baseline before device intervention (30 days), and after device intervention (60 days)
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Roll Evaluation of Activities of Life (REAL) assessment
Time frame: Change from Baseline before device intervention (30 days), and after device intervention (60 days)
The REAL is an instrument to help professionals assess a child's ability to care for themselves at home, at school and in the community.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing AbleLite in people with Muscular Dystrophies, run by AbiliTech Medical Inc..
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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 16 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Director of Clinical and Product Management (833.225.3123, info@abilitechmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: Change from Baseline before device intervention (30 days), and after device intervention (60 days)). 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?
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 16 Mar 2020.