NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

A Phase I/II Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children with Movement Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001180-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 17 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

EEG;
Muscular Dystophies;
Cerebral Palsy;
Knee;
incomplete spinal cord injury

Recruitment Keyword(s)

None

Condition(s)

Cerebral Palsy;
Muscular Dystrophy;
Spina Bifida;
Incomplete Spinal Cord Injury

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: EA-KAFO

Supporting Site

NIH Clinical Center

Background:

People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.

Objective:

To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.

Eligibility:

People aged 3 to 17 years with a gait disorder involving the knee joint.

Design:

Participants will be screened. They will have a physical exam. Their walking ability will be tested.

Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.

The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.

During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.

During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.

Participants walking ability will be retested after each phase.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

-Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.

-Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.

-Age 3 to 17 years old.

-Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.

-Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension/flexion) assessed with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.

-Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantar flexion) with the foot in neutral alignment.

-A measured foot-thigh angle of -15 to 30 degrees in prone position.

-Able to walk at least 10 feet without stopping with or without a walking aid.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

-Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton.

-A history of uncontrolled seizure in the past year.

-Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.

-Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Thomas C. Bulea, M.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7533
buleatc@mail.nih.gov

Thomas C. Bulea, M.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7533
buleatc@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05726591

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

A Phase I/II Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children with Movement Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001180-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 17 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

EEG;
Muscular Dystophies;
Cerebral Palsy;
Knee;
incomplete spinal cord injury

Recruitment Keyword(s)

None

Condition(s)

Cerebral Palsy;
Muscular Dystrophy;
Spina Bifida;
Incomplete Spinal Cord Injury

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: EA-KAFO

Supporting Site

NIH Clinical Center

Background:

People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.

Objective:

To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.

Eligibility:

People aged 3 to 17 years with a gait disorder involving the knee joint.

Design:

Participants will be screened. They will have a physical exam. Their walking ability will be tested.

Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.

The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.

During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.

During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.

Participants walking ability will be retested after each phase.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

-Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.

-Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.

-Age 3 to 17 years old.

-Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.

-Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension/flexion) assessed with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.

-Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantar flexion) with the foot in neutral alignment.

-A measured foot-thigh angle of -15 to 30 degrees in prone position.

-Able to walk at least 10 feet without stopping with or without a walking aid.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

-Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton.

-A history of uncontrolled seizure in the past year.

-Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.

-Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Thomas C. Bulea, M.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7533
buleatc@mail.nih.gov

Thomas C. Bulea, M.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7533
buleatc@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05726591

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