Hemiplegic Cerebral PalsyNCT05011201
Dual Joint Visual Feedback Gait Retraining in Pediatric Hemiplegic Cerebral Palsy
A study testing Dual Joint Visual Feedback without Scoring and Dual Joint Visual Feedback with Scoring in people with Hemiplegic Cerebral Palsy, run by Kessler Foundation at 1 site in United States.
Trial summary
This study aims to assess the feasibility of a visual feedback system designed to augment treadmill-based gait training for children with gait disturbances related to hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Dual Joint Visual Feedback without Scoring and Dual Joint Visual Feedback with Scoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2021to Aug 2022
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- I1: Diagnosis of hemiplegic cerebral palsy
- I2: Gait pattern in hemiplegic limb: deficit of knee extension during late swing phase/initial contact
- I3: Age 7 to 17 years
- I4: Able to walk on a treadmill without assistive devices
- I5: Able to understand spoken English at the level needed to:
- understand and follow instructions for equipment setup, testing and task performance
- answer questions related to effort and preference
- be able to understand consent document and provide informed consent
Who cannot join
- E1: Significant injury (such as fracture) in legs or feet that interferes with their ability to walk
- E2: Known risk factor for stroke or heart attack while exercising
- E3: Lower extremity orthopaedic surgery less than 12 months prior to study start
- E4: Other significant health conditions that may interfere with the participant's ability to complete the study or could interfere with interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Peter J Barrance, PhD, 973-324-3550, PBarrance@KesslerFoundation.org
Peter J Barrance, PhD
About this study
Official title: Impact and Feasibility of a Dual Joint Visual Feedback Design in Pediatrics With Hemiplegic Cerebral Palsy: A Pilot Study
This study aims to assess the feasibility of a visual feedback system designed to augment treadmill-based gait training for children with gait disturbances related to hemiplegic cerebral palsy. The visual feedback uses data from knee and hip joint movements to represent the position of the foot ahead of or behind the body during walking. This study will test eight children with hemiplegic cerebral palsy who have short step lengths related to atypical knee and hip motions when the foot contacts the ground (initial contact). The study will examine walking adaptations in response to the new visual feedback system and compare differences in response and user experience between two variants of the new design. In a single visit, participants will undergo a gait retraining protocol using the dual joint visual feedback (DJVF) system. Hip and knee flexion angles of the paretic (weaker) side will be collected, analyzed, and compared during baseline walking and while responding to the two feedback variants. Muscle firing patterns will be studied using electrodes placed on key lower limb muscles. Study participants will be asked to report their experience and preferences following the gait retraining protocol. The study findings will be used to further refine the DJVF system in preparation for future studies.
Read the detailed description
Participant characteristics
This study will recruit 8 pediatric participants with hemiplegic gait secondary to CP, in accordance with the inclusion and exclusion criteria.
Dual Joint Visual Feedback System (DJVF)
The DJVF system uses four inertial measurement unit (IMU) sensors (MTW Devkit, Xsens Technologies BV, Enschede, Netherlands) which are placed on the pelvis, shank, thigh, and foot, to measure three-dimensional segment accelerations and orientations during gait. The software application has been developed by our study team using the MATLAB (Mathworks, Natick, MA) programming language and the application programming interface supplied with the Xsens system. Sensor data is relayed back to a controlling PC for processing and feedback display formulation in real-time. The primary feedback is in the form of a cursor representing the position of the foot ahead of or behind the body. Relative foot position is calculated using the segmental angle and lengths of the paretic thigh and shank. The feedback is designed to reward a more anterior foot placement at the initial contact phase of gait by awarding points according to target screen zones that the cursor enters. The zone reached is highlighted and the instantaneous score is displayed.
FBC vs FBCS: addition of cumulative scoring:
Two feedback conditions representing two variants will be tested. The first (FBC) is as above, with only instantaneous scoring. The FBCS condition will be the same as the FBC condition with the following addition: game context cues of the cumulative score will be provided as visual numerical count displayed to the right of the main feedback interface.
Study Protocol
Researchers will place inertial sensors on the pelvis, thigh, shank, and shoe of the paretic limb, using elastic wraps and medical tape. Researchers will place surface EMG sensors on the participant's lower extremity paretic side. If any sensors cannot be placed due to the presence of orthotics or other complicating factors, data for that sensor will not be collected. Researchers will check the signal of each sensor, by having participants perform some easy activities such as flexing their knee, squatting, going on their toes, and raising their toes.
Following setup, participants will first walk on the study treadmill at a self-selected comfortable speed while baseline (BAS) gait patterns are recorded. After the baseline trial, practice, and orientation to the feedback, including the FBC and FBCS variants, will occur. The order of these training blocks will be randomized prior to participant arrival. Between training blocks, participants will be allotted rest periods to reduce fatigue.
Following testing, participants will complete a questionnaire with items on a five-point ordinal scale describing their 1) comprehension of the feedback display, 2) self-rating of success, 3) preference of which feedback variant (intervention) they preferred, and 4) effort or exhaustion following training.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Dual Joint Visual Feedback without Scoring, Dual Joint Visual Feedback with Scoring
- Keywords
- gait, biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Joint Visual Feedback without ScoringDevice
Participants will walk on the treadmill while given instantaneous anterior and posterior foot position and immediate scoring information using the DJVF interface. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted.
Dual Joint Visual Feedback with ScoringDevice
Participants will walk on the treadmill using the same DJFB with additional visual cumulative scoring on their performance. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will undergo a single testing session of gait retraining using two variants of the dual joint visual feedback system (DJVF). The DJVF system uses IMU sensors to measure knee and hip joint motions and calculates the users foot position, relative to their pelvis. The relative foot position is represented in real time on a screen in front of the user with feedback designed to elicit increases in anteriorly located foot positions. Receives: Device: Dual Joint Visual Feedback without Scoring; Device: Dual Joint Visual Feedback with Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee flexion angle at initial contact without feedback
Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase without feedback
Measured: 1 day (At single time point)
Knee flexion angle at initial contact during FBC exposure
Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback
Measured: 1 day (At single time point)
Knee flexion angle at initial contact during FBCS exposure
Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback
Measured: 1 day (At single time point)
Hip flexion angle at initial contact without feedback
Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase without feedback
Measured: 1 day (At single time point)
Hip flexion angle at initial contact during FBC exposure
Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback
Measured: 1 day (At single time point)
Hip flexion angle at initial contact during FBCS exposure
Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback
Measured: 1 day (At single time point)
Participant questionnaire responses
Participant responses to a five-point ordinal scale detailing their 1) comprehension of the feedback display, 2) self-rating of success, 3) preference of which feedback variant (intervention) they preferred, and 4) effort or exhaustion following training.
Measured: 1 day (At single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start19 Nov 2021
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will take part in the same interventional model. Participants will undergo several gait retraining bouts using two variants of the DJVF system. The order of bouts during the gait retraining will be block randomized.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Specialized Hospital
- Responsible party
- Sponsor
- Investigators
- Peter J Barrance, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011201
- Sponsor's protocol ID
- R-1151-21
- Status last verified
- Jan 2022
- First submitted
- 27 Jul 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Feasibility of a Dual Joint Visual Feedback Design in Pediatrics With Hemiplegic Cerebral Palsy: A Pilot Study
- ClinicalTrials.gov ID
- NCT05011201
- Acronym / sponsor ID
- R-1151-21
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- gait, biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Children's Specialized Hospital
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 18 Aug 2021 (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.
This study aims to assess the feasibility of a visual feedback system designed to augment treadmill-based gait training for children with gait disturbances related to hemiplegic cerebral palsy. The visual feedback uses data from knee and hip joint movements to represent the position of the foot ahead of or behind the body during walking. This study will test eight children with hemiplegic cerebral palsy who have short step lengths related to atypical knee and hip motions when the foot contacts the ground (initial contact). The study will examine walking adaptations in response to the new visual feedback system and compare differences in response and user experience between two variants of the new design. In a single visit, participants will undergo a gait retraining protocol using the dual joint visual feedback (DJVF) system. Hip and knee flexion angles of the paretic (weaker) side will be collected, analyzed, and compared during baseline walking and while responding to the two feedback variants. Muscle firing patterns will be studied using electrodes placed on key lower limb muscles. Study participants will be asked to report their experience and preferences following the gait retraining protocol. The study findings will be used to further refine the DJVF system in preparation for future studies.
Detailed description
Participant characteristics
This study will recruit 8 pediatric participants with hemiplegic gait secondary to CP, in accordance with the inclusion and exclusion criteria.
Dual Joint Visual Feedback System (DJVF)
The DJVF system uses four inertial measurement unit (IMU) sensors (MTW Devkit, Xsens Technologies BV, Enschede, Netherlands) which are placed on the pelvis, shank, thigh, and foot, to measure three-dimensional segment accelerations and orientations during gait. The software application has been developed by our study team using the MATLAB (Mathworks, Natick, MA) programming language and the application programming interface supplied with the Xsens system. Sensor data is relayed back to a controlling PC for processing and feedback display formulation in real-time. The primary feedback is in the form of a cursor representing the position of the foot ahead of or behind the body. Relative foot position is calculated using the segmental angle and lengths of the paretic thigh and shank. The feedback is designed to reward a more anterior foot placement at the initial contact phase of gait by awarding points according to target screen zones that the cursor enters. The zone reached is highlighted and the instantaneous score is displayed.
FBC vs FBCS: addition of cumulative scoring:
Two feedback conditions representing two variants will be tested. The first (FBC) is as above, with only instantaneous scoring. The FBCS condition will be the same as the FBC condition with the following addition: game context cues of the cumulative score will be provided as visual numerical count displayed to the right of the main feedback interface.
Study Protocol
Researchers will place inertial sensors on the pelvis, thigh, shank, and shoe of the paretic limb, using elastic wraps and medical tape. Researchers will place surface EMG sensors on the participant's lower extremity paretic side. If any sensors cannot be placed due to the presence of orthotics or other complicating factors, data for that sensor will not be collected. Researchers will check the signal of each sensor, by having participants perform some easy activities such as flexing their knee, squatting, going on their toes, and raising their toes.
Following setup, participants will first walk on the study treadmill at a self-selected comfortable speed while baseline (BAS) gait patterns are recorded. After the baseline trial, practice, and orientation to the feedback, including the FBC and FBCS variants, will occur. The order of these training blocks will be randomized prior to participant arrival. Between training blocks, participants will be allotted rest periods to reduce fatigue.
Following testing, participants will complete a questionnaire with items on a five-point ordinal scale describing their 1) comprehension of the feedback display, 2) self-rating of success, 3) preference of which feedback variant (intervention) they preferred, and 4) effort or exhaustion following training.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will take part in the same interventional model. Participants will undergo several gait retraining bouts using two variants of the DJVF system. The order of bouts during the gait retraining will be block randomized.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Dual Joint Visual Feedback without Scoring, Device: Dual Joint Visual Feedback with ScoringParticipants will undergo a single testing session of gait retraining using two variants of the dual joint visual feedback system (DJVF). The DJVF system uses IMU sensors to measure knee and hip joint motions and calculates the users foot position, relative to their pelvis. The relative foot position is represented in real time on a screen in front of the user with feedback designed to elicit increases in anteriorly located foot positions. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- I1: Diagnosis of hemiplegic cerebral palsy
- I2: Gait pattern in hemiplegic limb: deficit of knee extension during late swing phase/initial contact
- I3: Age 7 to 17 years
- I4: Able to walk on a treadmill without assistive devices
- I5: Able to understand spoken English at the level needed to:
Key exclusion criteria (4 listed)
- E1: Significant injury (such as fracture) in legs or feet that interferes with their ability to walk
- E2: Known risk factor for stroke or heart attack while exercising
- E3: Lower extremity orthopaedic surgery less than 12 months prior to study start
- E4: Other significant health conditions that may interfere with the participant's ability to complete the study or could interfere with interpretation of the study results.
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 |
|---|---|---|
| Dual Joint Visual Feedback without ScoringParticipants will walk on the treadmill while given instantaneous anterior and posterior foot position and immediate scoring information using the DJVF interface. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted. | Device | Experimental Group |
| Dual Joint Visual Feedback with ScoringParticipants will walk on the treadmill using the same DJFB with additional visual cumulative scoring on their performance. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted. | Device | Experimental Group |
Primary outcome
Knee flexion angle at initial contact without feedback
Time frame: 1 day (At single time point)
Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase without feedback
Knee flexion angle at initial contact during FBC exposure
Time frame: 1 day (At single time point)
Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback
Knee flexion angle at initial contact during FBCS exposure
Time frame: 1 day (At single time point)
Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback
Hip flexion angle at initial contact without feedback
Time frame: 1 day (At single time point)
Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase without feedback
Hip flexion angle at initial contact during FBC exposure
Time frame: 1 day (At single time point)
Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback
Hip flexion angle at initial contact during FBCS exposure
Time frame: 1 day (At single time point)
Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback
Participant questionnaire responses
Time frame: 1 day (At single time point)
Participant responses to a five-point ordinal scale detailing their 1) comprehension of the feedback display, 2) self-rating of success, 3) preference of which feedback variant (intervention) they preferred, and 4) effort or exhaustion following training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- 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.
Peter J Barrance, 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 Dual Joint Visual Feedback without Scoring and Dual Joint Visual Feedback with Scoring in people with Hemiplegic Cerebral Palsy, 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 8 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter J Barrance, PhD (9733243550, pbarrance@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee flexion angle at initial contact without feedback (time frame: 1 day (At single time point)). 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 19 Jan 2022.