OrthosesNCT04565639
Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
A study testing Powered Hand Orthosis in people with Orthoses and Prostheses, run by Liberating Technologies, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate pinch strength improvements and improvements in coordination and functional ability. Pinch strength measurements are made on subjects both with and without the device to evaluate the potential improvements. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthoses, Prostheses
- What is being tested?
- Powered Hand Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 7 Nov 2019
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participants in this study must meet the following inclusion/exclusion criteria.
- Subjects diagnosed with one of these conditions- ALS, brachial plexus injuries, CVA hemiplegia, multiple sclerosis, muscular dystrophy, spinal cord injury, and traumatic brain injury
- Range of motion (ROM) and strength characterized by one of the following limitations:
- Range of motion within functional limits (as determined by our OT consultant Deb Latour), but with limited pinch strength measured by a pinch meter of less than 2 pounds or manual muscle test grade of 3.
- Limited range of motion of the wrist, thumb, index, and middle fingers as determined by a clinical occupational therapist
- Passive ROM within functional limits as determined by our OT consultant Deb Latour
- No tremors in the hand or arm
- Must be able to understand and follow up to 3 step directions for testing
- No other comorbidities that may affect their ability to use the device
- Modified Ashworth Scale assessment for spasticity of less than 2
- Greater than 18 years old
- Must be able to wear a powered hand orthosis device.
- Be able to make the required visit(s) to LTI for testing
- Mini-mental test [2] score greater than 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Liberating Technologies, Inc
Holliston, Massachusetts, 01746
About this study
The primary objective of this study is to evaluate pinch strength improvements and improvements in coordination and functional ability. Pinch strength measurements are made on subjects both with and without the device to evaluate the potential improvements. Also, coordination and functional testing is performed both with and without the device to compare performance under both conditions and evaluate potential improvement.
Read the detailed description
This study tests the powered hand orthosis device on a small number of participants (up to 6). Research participants with neuromusculoskeletal impairments were recruited for the study and consented with an approved protocol. The study was conducted during 1 visit to LTI in Holliston, MA . The study consists of several assessments. Participants are surveyed for cognitive limitations and self-assessment of difficulties in completing tasks of daily living by completing surveys such as the Quickdash Questionnaire [1], the Mini-Mental State test [2], and the McGann Feedback form [3]. Pinch strength without and with the powered orthosis is evaluated. A selection of functional outcome measures are performed such as the Southampton Hand Assessment Procedure (SHAP) [4], the Nine-Hole Peg Test (NHP) [5], and the Box and Blocks Test (BBT) [6].
- Conditions
- Orthoses, Prostheses
- Being tested
- Powered Hand Orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Hand OrthosisDevice
A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Power Hand Orthosis | Experimental | Participants will test the improved grip strength using the powered hand orthosis system. Receives: Device: Powered Hand Orthosis |
| Experimental Power Hand Orthosis - Tasks of Daily Living | Experimental | Participants will test the improved ability to perform tasks of daily living using the powered hand orthosis system. Receives: Device: Powered Hand Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained grip strength
The sustained grip available for achieving activities of daily living that require a sustained grip
Measured: 1 minute
Secondary outcomes (2)
Maximum Grip Strength
The maximum strength available for achieving activities of daily living
Measured: 10 seconds
Accomplishing activities of daily living
Subjects were tested to accomplish a number of activities of daily living both with and without the device. Initial activities included the SHAP protocol and other activities that were identified by our occupational therapist consultant as relevant to the device.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start14 Aug 2019
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthosesStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberating Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Keough, Principal investigator, Liberating Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565639
- Sponsor's protocol ID
- 120190037
- Status last verified
- Sep 2020
- First submitted
- 31 Aug 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
- ClinicalTrials.gov ID
- NCT04565639
- Acronym / sponsor ID
- 120190037
- Conditions
- Orthoses, Prostheses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Liberating Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 25 Sep 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 this study is to evaluate pinch strength improvements and improvements in coordination and functional ability. Pinch strength measurements are made on subjects both with and without the device to evaluate the potential improvements. Also, coordination and functional testing is performed both with and without the device to compare performance under both conditions and evaluate potential improvement.
Detailed description
This study tests the powered hand orthosis device on a small number of participants (up to 6). Research participants with neuromusculoskeletal impairments were recruited for the study and consented with an approved protocol. The study was conducted during 1 visit to LTI in Holliston, MA . The study consists of several assessments. Participants are surveyed for cognitive limitations and self-assessment of difficulties in completing tasks of daily living by completing surveys such as the Quickdash Questionnaire [1], the Mini-Mental State test [2], and the McGann Feedback form [3]. Pinch strength without and with the powered orthosis is evaluated. A selection of functional outcome measures are performed such as the Southampton Hand Assessment Procedure (SHAP) [4], the Nine-Hole Peg Test (NHP) [5], and the Box and Blocks Test (BBT) [6].
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Power Hand Orthosis | Experimental | Device: Powered Hand OrthosisParticipants will test the improved grip strength using the powered hand orthosis system. |
| Experimental Power Hand Orthosis - Tasks of Daily Living | Experimental | Device: Powered Hand OrthosisParticipants will test the improved ability to perform tasks of daily living using the powered hand orthosis system. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Powered Hand OrthosisA prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living. | Device | Experimental Power Hand Orthosis, Experimental Power Hand Orthosis - Tasks of Daily Living |
Primary outcome
Sustained grip strength
Time frame: 1 minute
The sustained grip available for achieving activities of daily living that require a sustained grip
2 secondary outcomes
Maximum Grip Strength
Time frame: 10 seconds
Accomplishing activities of daily living
Time frame: 10 minutes
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 25 Sep 2020.
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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.
Kevin Keough principal investigator
Liberating Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered Hand Orthosis in people with Orthoses and Prostheses, run by Liberating Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Sep 2020. 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 United States. 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?
Sustained grip strength (time frame: 1 minute). 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 25 Sep 2020.