SCI - Spinal Cord InjuryNCT06643312
TPAD for Recovery of Standing After Severe SCI
A study testing The Tethered Pelvic Assist Device (TPAD) in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD. The main aims are to: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- The Tethered Pelvic Assist Device (TPAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age at the time of enrollment;
- stable medical condition
- at least one year post-spinal cord injury (Groups 1-4)
- non-progressive, traumatic SCI above T10 (Groups 1-4)
- Injury Grade A, B, C or D (Groups 1-4)
- ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3)
- inability to stand independently (Groups 2 and 4)
Who cannot join
- unwillingness to wean from anti-spasticity medications;
- untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
- history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
- ongoing drug abuse
- untreated psychiatric disorders or clinical depression
- received botox injections in lower extremities in the prior six months
Show all 10Show fewer
- Cardiopulmonary disease that may interfere with assessments
- Untreated severe and persistent dysautonomia
- Neurological injury or disease (Group 5)
- Orthopedic injury or condition (Group 5)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gail F Forrest, PhD contact
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Research Manager, 973-324-3557, LMartinez@KesslerFoundation.Org
About this study
Official title: Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
The purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD.
The main aims are to:
Read more
- Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance
2 and 3. Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals.
Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury:
Group 1:
- Individuals with SCI that can stand independently
- Will receive TPAD training
- Will undergo standing, posture, sitting, and stepping assessments
- Participation in this group will last about six months
Group 2:
- Individuals with SCI that cannot stand independently
- Will receive TPAD training
- Will undergo standing, posture, sitting, and stepping assessments
- Participation in this group will last about 6 months
Group 3:
- Individuals with SCI that can stand independently
- Will undergo standing and posture assessments
- Participation in this group will last about 2 weeks
Group 4:
- Individuals with SCI that cannot stand independently
- Will undergo standing and posture assessments
- Participation in this group will last about 2 weeks
Group 5:
- Individuals without a SCI
- Will undergo standing, posture, and sitting assessments
- Participation in this group will last about 2 weeks
Read the detailed description
The investigators will be testing a device called the Tethered Pelvic Assist Device or TPAD. The TPAD provides active control and support of the trunk, pelvis, and knees during training to improve the ability to stand. Also, the TPAD can be used to safely challenge participants during standing by providing controlled "pushes" or "perturbations" that must be corrected for in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury.
Methodology:
The Tethered Pelvic Assist Device (TPAD) is a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
A total of 50 participants will be enrolled in this study; they will be broken into five groups with 10 participants in each. All participants will undergo a physical classification of their spinal cord injury to determine eligibility and which group they belong in. Group 1 will consist of individuals with SCI that can stand independently and will receive TPAD training and assessments, Group 2 will consist of individuals with SCI that cannot stand independently and will receive TPAD training and assessments, Group 3 will consist of individuals with SCI that can stand independently and will receive assessments only, Group 4 will consist of individuals with SCI that cannot stand independently and will receive assessments only, and Group 5 will consist of individuals without a SCI that will receive assessments only. Each individual will serve as their own control, to reduce variability. Motor patterns recorded from the SCI research participants will be also compared to those collected from individuals who do not have a SCI. All participants will undergo the Stable Standing Assessment and Postural Perturbation Assessment. Groups 1, 2, and 5 will additionally perform the Stable Sitting Assessment and Postural Perturbation Assessment in Sitting. Only Groups 1 and 2 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- The Tethered Pelvic Assist Device (TPAD)
- Keywords
- TPAD
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Tethered Pelvic Assist Device (TPAD)Device
a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | * Individuals with SCI that can stand independently
* Will receive TPAD training
* Will undergo standing, posture, sitting, and stepping assessments
* Participation in this group will last about six months Receives: Device: The Tethered Pelvic Assist Device (TPAD) |
| Group 2 | Other | * Individuals with SCI that cannot stand independently
* Will receive TPAD training
* Will undergo standing, posture, sitting, and stepping assessments
* Participation in this group will last about 6 months Receives: Device: The Tethered Pelvic Assist Device (TPAD) |
| Group 3 | No intervention | * Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks |
| Group 4 | No intervention | * Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks |
| Group 5 | No intervention | * Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting Assessment
Research participants will sit on a padded table and perform tasks to challenge their balance control (reaching/shifting weight in multiple directions). Assistance for sitting will be provided at the trunk by the TPAD or by the trainer. EMG and kinematic analysis will be performed on the lower extremities, trunk and upper extremities during sitting. The trunk force and position controller data from the TPAD will be also collected; these data will be synchronized with EMG and kinematic data. Muscle activation patterns will be evaluated recording EMG from different muscle groups. The TPAD/trainer will then generate controlled loss of balance during sitting. EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance will be compared. EMG mean and integrated amplitudes from each muscle will be compared before and after training. Relationships between these parameters will also be calculated and compared with non-disabled data.
Measured: On average 4 hours to complete. Done at the beginning of the study for groups 1, 2, and 5. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Neuromuscular Recovery Scale (NRS)
Research participants will undergo a series of tasks to test the level of muscle activation and amount of assistance required during standing and stepping in a body-weight supported treadmill environment, as well as overground motor tasks. Arm, trunk/leg movement recovery and independency will be measured by the NRS using 14 motor tasks (sit, reverse sit up, sit up, sitting truck extension, overhead press, forward reach and grasp, door pull and open, can open and manipulation, sit to stand, stand, walking, stand adaptability, step retraining, and step adaptability) and combined with EMG, kinematic, and kinetic analyses on the upper and lower extremities and/or trunk. Based on the performance across categories, 4 phase scores can be assigned:1- greatest impairment relative to normal movement patterns (non-ambulatory), 2- begins to stand and weight support independently, 3- walking with varying skill levels, and 4- normal locomotor and transfer performance with adaptability.
Measured: On average, 2 hours to complete. Groups 1 and 2 will complete the NRS at the beginning of the study and at the end (on average 6 months).
Standing Assessment
Participants will stand as long as possible and undergo a series of standing tasks. Electromyography (EMG), kinematic and kinetic analysis will be performed on the lower extremities and trunk during standing. The pelvic, trunk and knee force and position controller data from the TPAD will be collected and synchronized. Muscle activation patterns will be evaluated recording EMG from different muscle groupings. When appropriate, ground reaction forces will be measured. Blood pressure and heart rate will be measured. The TPAD will then generate controlled loss of balance during standing. Participants will regain balance with/without grasping a fixed object. Investigators will compare EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance if applicable. EMG mean and amplitudes from each muscle will be compared before and after training. The relationship between these parameters will also be calculated and compared with non-disabled data.
Measured: On average 4 hours to complete. Done at the beginning of the study for all groups. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start22 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will include 50 participants, 20 with SCI who are able to stand independently for short periods of time (\<1 hour) (Groups 1 \& 3), 20 participants with SCI who are unable to stand independently (Groups 2 \& 4), and 10 non-disabled individuals (Group 5). Group 1 (n=10) will be evaluated before and after receiving stand training with the TPAD. Group 2 (n=10) will be evaluated before and after receiving stand training with the TPAD. Group 3 (n=10) will be evaluated without receiving any intervention. Group 4 (n=10) will be evaluated without receiving any intervention. Groups 3 and 4, who will not receive any intervention, will undergo the Stable Standing Assessment and the Postural Perturbation Assessment only. Group 5 (n=10) will undergo assessments only. Each individual will serve as their own control, reducing the variability among individuals. Motor patterns recorded from the SCI participants will be also compared to those collected from non-disabled individuals.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Forrest, Kessler Foundation
- Investigators
- Gail F Forrest, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643312
- Sponsor's protocol ID
- R-1232-23
- Status last verified
- Dec 2024
- First submitted
- 18 Sep 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All Individual Participant Data (IPD) will be kept with the study research team at Kessler Foundation. IPD will be de-identified and may be shared with the device research team at Columbia University, the FDA, Kessler Foundation Institutional Review Board, the Department of Health and Human Services, and collaborators at the Kentucky Spinal Cord Injury Research Center.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
- ClinicalTrials.gov ID
- NCT06643312
- Acronym / sponsor ID
- R-1232-23
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- TPAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Oct 2024 (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 purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD.
The main aims are to:
- Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance
2 and 3. Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals.
Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury:
Group 1:
- Individuals with SCI that can stand independently
- Will receive TPAD training
- Will undergo standing, posture, sitting, and stepping assessments
- Participation in this group will last about six months
Group 2:
- Individuals with SCI that cannot stand independently
- Will receive TPAD training
- Will undergo standing, posture, sitting, and stepping assessments
- Participation in this group will last about 6 months
Group 3:
- Individuals with SCI that can stand independently
- Will undergo standing and posture assessments
- Participation in this group will last about 2 weeks
Group 4:
- Individuals with SCI that cannot stand independently
- Will undergo standing and posture assessments
- Participation in this group will last about 2 weeks
Group 5:
- Individuals without a SCI
- Will undergo standing, posture, and sitting assessments
- Participation in this group will last about 2 weeks
Detailed description
The investigators will be testing a device called the Tethered Pelvic Assist Device or TPAD. The TPAD provides active control and support of the trunk, pelvis, and knees during training to improve the ability to stand. Also, the TPAD can be used to safely challenge participants during standing by providing controlled "pushes" or "perturbations" that must be corrected for in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury.
Methodology:
The Tethered Pelvic Assist Device (TPAD) is a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
A total of 50 participants will be enrolled in this study; they will be broken into five groups with 10 participants in each. All participants will undergo a physical classification of their spinal cord injury to determine eligibility and which group they belong in. Group 1 will consist of individuals with SCI that can stand independently and will receive TPAD training and assessments, Group 2 will consist of individuals with SCI that cannot stand independently and will receive TPAD training and assessments, Group 3 will consist of individuals with SCI that can stand independently and will receive assessments only, Group 4 will consist of individuals with SCI that cannot stand independently and will receive assessments only, and Group 5 will consist of individuals without a SCI that will receive assessments only. Each individual will serve as their own control, to reduce variability. Motor patterns recorded from the SCI research participants will be also compared to those collected from individuals who do not have a SCI. All participants will undergo the Stable Standing Assessment and Postural Perturbation Assessment. Groups 1, 2, and 5 will additionally perform the Stable Sitting Assessment and Postural Perturbation Assessment in Sitting. Only Groups 1 and 2 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study will include 50 participants, 20 with SCI who are able to stand independently for short periods of time (<1 hour) (Groups 1 \& 3), 20 participants with SCI who are unable to stand independently (Groups 2 \& 4), and 10 non-disabled individuals (Group 5). Group 1 (n=10) will be evaluated before and after receiving stand training with the TPAD. Group 2 (n=10) will be evaluated before and after receiving stand training with the TPAD. Group 3 (n=10) will be evaluated without receiving any intervention. Group 4 (n=10) will be evaluated without receiving any intervention. Groups 3 and 4, who will not receive any intervention, will undergo the Stable Standing Assessment and the Postural Perturbation Assessment only. Group 5 (n=10) will undergo assessments only. Each individual will serve as their own control, reducing the variability among individuals. Motor patterns recorded from the SCI participants will be also compared to those collected from non-disabled individuals.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: The Tethered Pelvic Assist Device (TPAD)* Individuals with SCI that can stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about six months |
| Group 2 | Other | Device: The Tethered Pelvic Assist Device (TPAD)* Individuals with SCI that cannot stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about 6 months |
| Group 3 | No intervention | –* Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks |
| Group 4 | No intervention | –* Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks |
| Group 5 | No intervention | –* Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age at the time of enrollment;
- stable medical condition
- at least one year post-spinal cord injury (Groups 1-4)
- non-progressive, traumatic SCI above T10 (Groups 1-4)
- Injury Grade A, B, C or D (Groups 1-4)
Key exclusion criteria (10 listed)
- unwillingness to wean from anti-spasticity medications;
- untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
- history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
- ongoing drug abuse
- untreated psychiatric disorders or clinical depression
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 |
|---|---|---|
| The Tethered Pelvic Assist Device (TPAD)a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing. | Device | Group 1, Group 2 |
Primary outcome
Sitting Assessment
Time frame: On average 4 hours to complete. Done at the beginning of the study for groups 1, 2, and 5. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Research participants will sit on a padded table and perform tasks to challenge their balance control (reaching/shifting weight in multiple directions). Assistance for sitting will be provided at the trunk by the TPAD or by the trainer. EMG and kinematic analysis will be performed on the lower extremities, trunk and upper extremities during sitting. The trunk force and position controller data from the TPAD will be also collected; these data will be synchronized with EMG and kinematic data. Muscle activation patterns will be evaluated recording EMG from different muscle groups. The TPAD/trainer will then generate controlled loss of balance during sitting. EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance will be compared. EMG mean and integrated amplitudes from each muscle will be compared before and after training. Relationships between these parameters will also be calculated and compared with non-disabled data.
Neuromuscular Recovery Scale (NRS)
Time frame: On average, 2 hours to complete. Groups 1 and 2 will complete the NRS at the beginning of the study and at the end (on average 6 months).
Research participants will undergo a series of tasks to test the level of muscle activation and amount of assistance required during standing and stepping in a body-weight supported treadmill environment, as well as overground motor tasks. Arm, trunk/leg movement recovery and independency will be measured by the NRS using 14 motor tasks (sit, reverse sit up, sit up, sitting truck extension, overhead press, forward reach and grasp, door pull and open, can open and manipulation, sit to stand, stand, walking, stand adaptability, step retraining, and step adaptability) and combined with EMG, kinematic, and kinetic analyses on the upper and lower extremities and/or trunk. Based on the performance across categories, 4 phase scores can be assigned:1- greatest impairment relative to normal movement patterns (non-ambulatory), 2- begins to stand and weight support independently, 3- walking with varying skill levels, and 4- normal locomotor and transfer performance with adaptability.
Standing Assessment
Time frame: On average 4 hours to complete. Done at the beginning of the study for all groups. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Participants will stand as long as possible and undergo a series of standing tasks. Electromyography (EMG), kinematic and kinetic analysis will be performed on the lower extremities and trunk during standing. The pelvic, trunk and knee force and position controller data from the TPAD will be collected and synchronized. Muscle activation patterns will be evaluated recording EMG from different muscle groupings. When appropriate, ground reaction forces will be measured. Blood pressure and heart rate will be measured. The TPAD will then generate controlled loss of balance during standing. Participants will regain balance with/without grasping a fixed object. Investigators will compare EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance if applicable. EMG mean and amplitudes from each muscle will be compared before and after training. The relationship between these parameters will also be calculated and compared with non-disabled data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No. All Individual Participant Data (IPD) will be kept with the study research team at Kessler Foundation. IPD will be de-identified and may be shared with the device research team at Columbia University, the FDA, Kessler Foundation Institutional Review Board, the Department of Health and Human Services, and collaborators at the Kentucky Spinal Cord Injury Research Center.
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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.
Gail F Forrest, PhD contact
Gail F Forrest, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Tethered Pelvic Assist Device (TPAD) in people with SCI - Spinal Cord Injury, run by Kessler Foundation 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?
The sponsor lists 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Manager (9733243557, LMartinez@KesslerFoundation.Org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sitting Assessment (time frame: On average 4 hours to complete. Done at the beginning of the study for groups 1, 2, and 5. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).). The study lists 3 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 Dec 2024.