Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01961557
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2013-10-10
Brief Title:
Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders
Status:
RECRUITING
Status Verified Date:
2024-09-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Cerebral palsy CP is the most common motor disorder in children CP often causes crouch gait an abnormal way of walking Knee crouch has many causes so no single device or approach works best for everybody This study s adjustable brace provides many types of walking assistance Researchers will evaluate brace options to find the best solution for each participant and whether one solution works best for the group
Objective
- To evaluate a new brace to improve crouch gait in children with CP
Eligibility
Children 5 17 years old with CP
Healthy volunteers 5 17 years old
Design
All participants will be screened with medical history and physical exam
Healthy volunteers will have 1 visit They will do motion analysis EMG and EEG described below
Participants with CP will have 6 visits
Visit 1
TAB1 Motion analysis Balls will be taped to participants skin This helps cameras follow their movement
TAB2 EMG Metal discs will be taped to participants skin They measure electrical muscle activity
TAB3 Participants knee movement will be tested
TAB4 Participants will walk 50 meters
TAB5 Participants legs will be cast to make custom braces
Visit 2
Participants will wear their new braces and have them adjusted
Steps 1 3 will be repeated
EEG Small metal discs will be placed on the participants scalp They record brain waves
Participants will have electrical stimulation of their knees and practice extending them
Participants will take several walks with the braces in different settings
Visits 3 5 participants will repeat the walking and some other steps from visit 2
Visit 6 will repeat visit 2
- Cerebral palsy CP is the most common motor disorder in children CP often causes crouch gait an abnormal way of walking Knee crouch has many causes so no single device or approach works best for everybody This study s adjustable brace provides many types of walking assistance Researchers will evaluate brace options to find the best solution for each participant and whether one solution works best for the group
Objective
- To evaluate a new brace to improve crouch gait in children with CP
Eligibility
Children 5 17 years old with CP
Healthy volunteers 5 17 years old
Design
All participants will be screened with medical history and physical exam
Healthy volunteers will have 1 visit They will do motion analysis EMG and EEG described below
Participants with CP will have 6 visits
Visit 1
TAB1 Motion analysis Balls will be taped to participants skin This helps cameras follow their movement
TAB2 EMG Metal discs will be taped to participants skin They measure electrical muscle activity
TAB3 Participants knee movement will be tested
TAB4 Participants will walk 50 meters
TAB5 Participants legs will be cast to make custom braces
Visit 2
Participants will wear their new braces and have them adjusted
Steps 1 3 will be repeated
EEG Small metal discs will be placed on the participants scalp They record brain waves
Participants will have electrical stimulation of their knees and practice extending them
Participants will take several walks with the braces in different settings
Visits 3 5 participants will repeat the walking and some other steps from visit 2
Visit 6 will repeat visit 2
Detailed Description:
Objective
The purpose of this protocol is to evaluate several configurations of a prototype Extension Assist Knee-Ankle-Foot Orthosis EA-KAFO in patients with cerebral palsy CP muscular dystrophy MD spina bifida SB or incomplete spinal cord injury iSCI who have knee extension deficiency Three forms of assistance will be provided at the knee joint including a passive-damper component functional electrical stimulation FES to the quadriceps and a motorized assist One form will provide controllable resistance at the knee to strengthen muscles and promote knee extension after the resistance is removed These will be compared to traditional bracing which typically improves crouch by blocking some or all motion at one or both joints We hypothesize that all assistive configurations will improve gait alignment and performance compared to the non-assisted conditions We further hypothesize that a best solution for each participant will exist but may vary across subjects due to the heterogeneity of these movement disorders Preliminary data on brain activation using EEG will be collected during all walking conditions
Study population
Thirty 30 subjects age 5 and above diagnosed with crouch gait from diplegic CP 30 subjects age 5 and above with knee extension deficiency from MD SB or iSCI 15 from each group and 10 age-matched healthy volunteers will be recruited
Design
This protocol will evaluate an EA-KAFO prototype consisting of a custom fabricated brace combined with a modular knee joint with three modes of operation hinge no assist a passive spring-damper and an active motorized assist Since crouch can also be precipitated at the ankle the orthotic ankle joint has an adjustable dynamic resistance ADR mechanism that can be locked passive assist to simulate a standard brace free or provide variable resistance to assist knee extension Additionally we will combine quadriceps FES with the hinge and the passive damper to create two hybrid configurations The hinge and the passive damper Ultraflex knee modules and ADR ankle brace are FDA-approved Class I commercially available devices This protocol for evaluation of the active motorized joint module the two hybrid configurations and the controllable resistance device PowerWalk by Agilik Technologies has been reviewed by the FDA as a medical device study and was determined by the FDA to be non-significant risk Healthy controls will come for one visit and participants with movement disorders will complete 6-10 visits 1 initial assessment and casting for custom leg brace 2 EA-KAFO configuration 3 initial data collection and practice 4-5 accommodation to brace configurations 6 final data collection Additional accommodation visits may be added if necessary up to the maximum of 10 total visits Participants with movement disorders will be permitted to re-enroll in the protocol is a minimum of 1 year has passed from their prior final visit Motion capture force plates and electromyography EMG will be used for gait analysis while electroencephalography EEG will measure brain activity during walking
Outcome measures
The primary outcome is the amount of knee flexion during gait The optimal solution for each individual will be that which provides the greatest reduction in peak knee angle Secondary outcomes will include gait speed knee extensor moment and EEG activation profiles
The purpose of this protocol is to evaluate several configurations of a prototype Extension Assist Knee-Ankle-Foot Orthosis EA-KAFO in patients with cerebral palsy CP muscular dystrophy MD spina bifida SB or incomplete spinal cord injury iSCI who have knee extension deficiency Three forms of assistance will be provided at the knee joint including a passive-damper component functional electrical stimulation FES to the quadriceps and a motorized assist One form will provide controllable resistance at the knee to strengthen muscles and promote knee extension after the resistance is removed These will be compared to traditional bracing which typically improves crouch by blocking some or all motion at one or both joints We hypothesize that all assistive configurations will improve gait alignment and performance compared to the non-assisted conditions We further hypothesize that a best solution for each participant will exist but may vary across subjects due to the heterogeneity of these movement disorders Preliminary data on brain activation using EEG will be collected during all walking conditions
Study population
Thirty 30 subjects age 5 and above diagnosed with crouch gait from diplegic CP 30 subjects age 5 and above with knee extension deficiency from MD SB or iSCI 15 from each group and 10 age-matched healthy volunteers will be recruited
Design
This protocol will evaluate an EA-KAFO prototype consisting of a custom fabricated brace combined with a modular knee joint with three modes of operation hinge no assist a passive spring-damper and an active motorized assist Since crouch can also be precipitated at the ankle the orthotic ankle joint has an adjustable dynamic resistance ADR mechanism that can be locked passive assist to simulate a standard brace free or provide variable resistance to assist knee extension Additionally we will combine quadriceps FES with the hinge and the passive damper to create two hybrid configurations The hinge and the passive damper Ultraflex knee modules and ADR ankle brace are FDA-approved Class I commercially available devices This protocol for evaluation of the active motorized joint module the two hybrid configurations and the controllable resistance device PowerWalk by Agilik Technologies has been reviewed by the FDA as a medical device study and was determined by the FDA to be non-significant risk Healthy controls will come for one visit and participants with movement disorders will complete 6-10 visits 1 initial assessment and casting for custom leg brace 2 EA-KAFO configuration 3 initial data collection and practice 4-5 accommodation to brace configurations 6 final data collection Additional accommodation visits may be added if necessary up to the maximum of 10 total visits Participants with movement disorders will be permitted to re-enroll in the protocol is a minimum of 1 year has passed from their prior final visit Motion capture force plates and electromyography EMG will be used for gait analysis while electroencephalography EEG will measure brain activity during walking
Outcome measures
The primary outcome is the amount of knee flexion during gait The optimal solution for each individual will be that which provides the greatest reduction in peak knee angle Secondary outcomes will include gait speed knee extensor moment and EEG activation profiles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13-CC-0210 | None | None | None |