Cerebral PalsyNCT04717323
Precision Gait Retraining for Children With Cerebral Palsy
A study testing mPAD (or TPAD) Pelvic Assist Device in people with Cerebral Palsy and Gait Disorders, Neurologic, run by Altec Inc. at 2 sites in United States.
Trial summary
This project will develop the first sensor-based mobile Pelvic Assist Device (mPAD) that can deliver precise, adaptable, pelvic control to restore natural coordination of upper- and lower-limb movements during gait in children with Cerebral Palsy Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Gait Disorders, Neurologic
- What is being tested?
- mPAD (or TPAD) Pelvic Assist Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Nov 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children (6-18 years of age)
- Male or Female
- Confirmed diagnosis of Cerebral Palsy by a neurologist;
- CT or MRI imaging consistent with clinical presentation;
- Clinical evidence of preserved cognition as determined by the child's neurologist;
- Clinical evidence of Mild to Moderate spastic (pyramidal) diplegia as determined by the child's neurologist;
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- Gross Motor Function Classification System (GMFS) GMFCS Level II ("walks with limitations. Limitations include walking long distances and balancing, but not as able as Level I to run or jump; may require use of mobility devices when first learning to walk, usually prior to age 4; and may rely on wheeled mobility equipment when outside of home for traveling long distances."
- Spasticity being controlled by pharmaceutical or surgical correction; or has Modified Ashworth scale (MAS) = 0-2 ("More marked increase in muscle tone through most of the range of motion (ROM), but affected part(s) easily moved
- Ambulatory without assistive devices (except for long distances or on uneven terrain).
- No allergies to skin tape such as Band-Aid.
- Adults or Children (age≥6 y.o.)
- Male or Female;
- Able to walk independently and without assistive devices;
- No history of musculoskeletal or neurological disorders;
- Able to follow directions in English.
Who cannot join
- Inability to follow simple instructions in English, or through a Spanish-speaking translator;
- Medical history of other neurological conditions;
- Medical history of cardiac or respiratory complications, or disorders that would place the subject at risk for conducting the different motor activities;
- Contractures present in lower limb - evaluated based on Tardieu Scale test where joint range of motion is measured during slow velocity movements and where contracture is operationally defined as being present if the angle at the end of range is 5 -10 degrees less than full range at ankle; and 5 -20 degrees less than full range at hip and knee.
- Skin disorders that result in open lesions or hyper-sensitive/fragile skin, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
- Unable to provide Informed Consent from subject and Assent from parent or guardian using English or Spanish-translation informed consent form.
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- Non-English speaker;
- Unable to walk independently and without assistive devices;
- Medical history of neurological or musculoskeletal conditions (arthritis, spondylosis, etc.);
- Inability to follow simple instructions;
- Unable to provide informed consent in English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altec Inc.
Natick, Massachusetts, 01760
CUMC Harkness Pavillion
New York, New York, 10032
About this study
This project will develop the first sensor-based mobile Pelvic Assist Device (mPAD) that can deliver precise, adaptable, pelvic control to restore natural coordination of upper- and lower-limb movements during gait in children with Cerebral Palsy
Read the detailed description
Gait impairments hinder mobility for more than 760,000 children and adults living with cerebral palsy (CP) in the US. Motor relearning is possible for these individual but typically requires numerous training sessions with a team of physical therapists and assistants to restore coupling between upper- and lower-body segments while assisting spastic uncoordinated limb movement to improve gait kinematics. This clinical trial will meet the overall objective of testing the feasibility of developing a smart-robotic exoskeleton that is effective at providing guided pelvic assistance and support while biofeedback mediated training is facilitated under the supervision of a physiotherapist. The project will test a novel tethered Pelvic Assist Device (TPAD) with integratable electromyographic (EMG) and inertial (IMU) biofeedback that is uniquely capable of delivering precise, adaptable, multi-degree-of-freedom pelvic control to promote natural intersegmental coupling, restore coordination of upper- and lower-limb movement, and improve normal gait kinematics in children with CP. Because of its proximity to the center of mass and critical role in coordinating upper- and lower-limb control, the pelvis provides an ideal access point for physiotherapists to manually improve gait. The investigators will test the hypothesis that accurate sensor-based metrics of gait can be derived from EMG and IMU wearable sensors to develop a biofeedback system for motor learning that are integratable with TPAD to develop a new mobile mPAD device that is compliant with the target population.
- Conditions
- Cerebral Palsy, Gait Disorders, Neurologic
- Being tested
- mPAD (or TPAD) Pelvic Assist Device, No Intervention
- Keywords
- CP (Cerebral Palsy), Diplegia, Spastic, Gait Disorders
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPAD (or TPAD) Pelvic Assist DeviceDevice
Also called mPAD (or TPAD)
Gait retraining device that applies pelvic forces and measures response
No InterventionDevice
Gait with no pelvic assistance
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Gait with and without pelvic assistance Receives: Device: mPAD (or TPAD) Pelvic Assist Device; Device: No Intervention |
| Controls | Experimental | Gait with no pelvic assistance Receives: Device: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Metric Accuracy
Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture
Measured: 1 day
Pelvis Range of Motion During Walking
Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture
Measured: 1 day
Muscle Activation During Walking
Measures electromyographic (EMG) signals of trunk and lower limb muscles during gait which are necessary for designing and implementing a mobile pelvic assist device (mPAD) system with biofeedback
Measured: 1 day
Rating of Perceived Difficulty
Structured interviews will be used to grade the perception of difficulty in using the technology
Measured: 1 day
Trunk Range of Motion During Walking
Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture
Measured: 1 day
Hip Range of Motion During Walking
Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture
Measured: 1 day
Knee Range of Motion During Walking
Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start11 Nov 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Paola Contessa, PhD, Principal investigator, Altec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717323
- Sponsor's protocol ID
- mPAD Phase 1
- Status last verified
- Feb 2022
- First submitted
- 7 Dec 2020
- Last updated
- 4 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Gait Retraining for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04717323
- Acronym / sponsor ID
- mPAD Phase 1
- Conditions
- Cerebral Palsy, Gait Disorders, Neurologic
- Keywords
- CP (Cerebral Palsy), Diplegia, Spastic, Gait Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Altec Inc.Industry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will develop the first sensor-based mobile Pelvic Assist Device (mPAD) that can deliver precise, adaptable, pelvic control to restore natural coordination of upper- and lower-limb movements during gait in children with Cerebral Palsy
Detailed description
Gait impairments hinder mobility for more than 760,000 children and adults living with cerebral palsy (CP) in the US. Motor relearning is possible for these individual but typically requires numerous training sessions with a team of physical therapists and assistants to restore coupling between upper- and lower-body segments while assisting spastic uncoordinated limb movement to improve gait kinematics. This clinical trial will meet the overall objective of testing the feasibility of developing a smart-robotic exoskeleton that is effective at providing guided pelvic assistance and support while biofeedback mediated training is facilitated under the supervision of a physiotherapist. The project will test a novel tethered Pelvic Assist Device (TPAD) with integratable electromyographic (EMG) and inertial (IMU) biofeedback that is uniquely capable of delivering precise, adaptable, multi-degree-of-freedom pelvic control to promote natural intersegmental coupling, restore coordination of upper- and lower-limb movement, and improve normal gait kinematics in children with CP. Because of its proximity to the center of mass and critical role in coordinating upper- and lower-limb control, the pelvis provides an ideal access point for physiotherapists to manually improve gait. The investigators will test the hypothesis that accurate sensor-based metrics of gait can be derived from EMG and IMU wearable sensors to develop a biofeedback system for motor learning that are integratable with TPAD to develop a new mobile mPAD device that is compliant with the target population.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: mPAD (or TPAD) Pelvic Assist Device, Device: No InterventionGait with and without pelvic assistance |
| Controls | Experimental | Device: No InterventionGait with no pelvic assistance |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Children (6-18 years of age)
- Male or Female
- Confirmed diagnosis of Cerebral Palsy by a neurologist;
- CT or MRI imaging consistent with clinical presentation;
- Clinical evidence of preserved cognition as determined by the child's neurologist;
Key exclusion criteria (11 listed)
- Inability to follow simple instructions in English, or through a Spanish-speaking translator;
- Medical history of other neurological conditions;
- Medical history of cardiac or respiratory complications, or disorders that would place the subject at risk for conducting the different motor activities;
- Contractures present in lower limb - evaluated based on Tardieu Scale test where joint range of motion is measured during slow velocity movements and where contracture is operationally defined as being present if the angle at the end of range is 5 -10 degrees less than full range at ankle; and 5 -20 degrees less than full range at hip and knee.
- Skin disorders that result in open lesions or hyper-sensitive/fragile skin, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
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 |
|---|---|---|
| mPAD (or TPAD) Pelvic Assist DeviceAlso: mPAD (or TPAD)Gait retraining device that applies pelvic forces and measures response | Device | Patients |
| No InterventionGait with no pelvic assistance | Device | Controls, Patients |
Primary outcome
Gait Metric Accuracy
Time frame: 1 day
Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture
Pelvis Range of Motion During Walking
Time frame: 1 day
Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture
Muscle Activation During Walking
Time frame: 1 day
Measures electromyographic (EMG) signals of trunk and lower limb muscles during gait which are necessary for designing and implementing a mobile pelvic assist device (mPAD) system with biofeedback
Rating of Perceived Difficulty
Time frame: 1 day
Structured interviews will be used to grade the perception of difficulty in using the technology
Trunk Range of Motion During Walking
Time frame: 1 day
Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture
Hip Range of Motion During Walking
Time frame: 1 day
Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture
Knee Range of Motion During Walking
Time frame: 1 day
Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Paola Contessa, PhD principal investigator
Altec Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPAD (or TPAD) Pelvic Assist Device in people with Cerebral Palsy and Gait Disorders, Neurologic, run by Altec Inc. at 2 sites 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?
The sponsor lists 15 inclusion and 11 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gait Metric Accuracy (time frame: 1 day). The study lists 7 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 4 Mar 2022.