Cerebral PalsyNCT05024409
Cerebral Palsy Upper Extremity Orthotic Device
A study testing Upper Extremity Orthotic and Occupational Therapy in people with Cerebral Palsy, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
Upper extremity therapies for children with cerebral palsy (CP) have been validated for improving function in higher functioning patients. Those who function at the lowest end of the scale, on the Manual Ability Classification System scale (MACS) III-V, comprise 34-54% of the population, but as yet have no… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Upper Extremity Orthotic and Occupational Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2023to 1 Dec 2025
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of cerebral palsy, age 4-17 years, moderate-severe hand disability as graded by the Manual Ability Classification System, active movement of the elbow, ability to follow commands and participate in goal-making and repetitive tasks
Who cannot join
- mild or extremely severe hand disability, Botox or orthopaedic surgery within the past 6 months, severe contractures, lack of voluntary arm motion, unable to follow commands due to severe cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Rutgers NJMS
Newark, New Jersey, 07103
Alice Chu, MD, 973-972-2076, chual@njms.rutgers.edu
- Recruiting
Children's Specialized Hospital
Union, New Jersey, 07083
Janelle Lenzo-Werner, 888-244-5373, jlenzo-werner@childrens-specialized.org
About this study
Official title: Use of Low Cost Orthotic Device to Improve Upper Extremity Function in Children With Cerebral Palsy
Upper extremity therapies for children with cerebral palsy (CP) have been validated for improving function in higher functioning patients. Those who function at the lowest end of the scale, on the Manual Ability Classification System scale (MACS) III-V, comprise 34-54% of the population, but as yet have no evidence-based interventions specific to their needs. Lower functioning children often retain some voluntary control of the elbow in spite of limited finger motion. A dynamic splint, or exoskeleton, could utilize the tenodesis effect from elbow motion to drive finger release while retaining flexor tone for grasp, potentially creating a portable, home-based therapeutic tool. The purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.
- Conditions
- Cerebral Palsy
- Being tested
- Upper Extremity Orthotic, Occupational Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity OrthoticDevice
3D printed orthotic which uses elbow motion to facilitate finger extension
Occupational TherapyOther
6 weekly sessions of occupational therapy, without use of an assistive orthotic device
| Study group | Role | What they receive |
|---|---|---|
| Orthotic + Occupational Therapy | Experimental | Not described Receives: Device: Upper Extremity Orthotic |
| Occupational Therapy alone | Active comparator | Not described Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Assisting Hand Assessment from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. The scale is 0-100, and a higher score indicates better function. A change of +5 is clinically significant.
Measured: through study completion, an average of 6 months
Change in Melbourne Assessment-2 from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of movement, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement.
The full test comprises 14 test items which require a child to reach to, grasp, release and manipulate simple objects. Each child's test performance is video recorded for subsequent scoring.
Scoring is completed across the 30 score items using a three, four or five point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale. A raw score scale change of 3 for range of motion, dexterity, and fluency; and a change of 4 for accuracy is considered clinically significant.
Measured: through study completion, an average of 6 months
Change in Children's Hand Use Experience Questionnaire from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
CHEQ is a newly developed questionnaire. It has been developed for children and adolescents with decreased function in one hand, for example hemiplegic CP, obstetric brachial plexus palsy (OBPP) and upper limb reduction deficiency, and for their parents. The scale is 0-100, with the higher score indicating better abilities.
Measured: through study completion, an average of 6 months
Change in range of motion for shoulder, elbow, forearm, wrist, and fingers from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Measured: pre treatment, immediate post treatment, and 3 month followup
Secondary outcomes (1)
Change in motion analysis parameters from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Measured: pre treatment, immediate post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jan 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Chu, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024409
- Sponsor's protocol ID
- Pro2020000653
- Status last verified
- Dec 2023
- First submitted
- 3 Aug 2021
- Last updated
- 26 Dec 2023
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low Cost Orthotic Device to Improve Upper Extremity Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05024409
- Acronym / sponsor ID
- Pro2020000653
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 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.
Upper extremity therapies for children with cerebral palsy (CP) have been validated for improving function in higher functioning patients. Those who function at the lowest end of the scale, on the Manual Ability Classification System scale (MACS) III-V, comprise 34-54% of the population, but as yet have no evidence-based interventions specific to their needs. Lower functioning children often retain some voluntary control of the elbow in spite of limited finger motion. A dynamic splint, or exoskeleton, could utilize the tenodesis effect from elbow motion to drive finger release while retaining flexor tone for grasp, potentially creating a portable, home-based therapeutic tool. The purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthotic + Occupational Therapy | Experimental | Device: Upper Extremity Orthotic |
| Occupational Therapy alone | Active comparator | Other: Occupational Therapy |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosis of cerebral palsy, age 4-17 years, moderate-severe hand disability as graded by the Manual Ability Classification System, active movement of the elbow, ability to follow commands and participate in goal-making and repetitive tasks
Key exclusion criteria (1 listed)
- mild or extremely severe hand disability, Botox or orthopaedic surgery within the past 6 months, severe contractures, lack of voluntary arm motion, unable to follow commands due to severe cognitive impairment
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 |
|---|---|---|
| Upper Extremity Orthotic3D printed orthotic which uses elbow motion to facilitate finger extension | Device | Orthotic + Occupational Therapy |
| Occupational Therapy6 weekly sessions of occupational therapy, without use of an assistive orthotic device | Other | Occupational Therapy alone |
Primary outcome
Change in Assisting Hand Assessment from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Time frame: through study completion, an average of 6 months
The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. The scale is 0-100, and a higher score indicates better function. A change of +5 is clinically significant.
Change in Melbourne Assessment-2 from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Time frame: through study completion, an average of 6 months
The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of movement, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. The full test comprises 14 test items which require a child to reach to, grasp, release and manipulate simple objects. Each child's test performance is video recorded for subsequent scoring. Scoring is completed across the 30 score items using a three, four or five point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale. A raw score scale change of 3 for range of motion, dexterity, and fluency; and a change of 4 for accuracy is considered clinically significant.
Change in Children's Hand Use Experience Questionnaire from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Time frame: through study completion, an average of 6 months
CHEQ is a newly developed questionnaire. It has been developed for children and adolescents with decreased function in one hand, for example hemiplegic CP, obstetric brachial plexus palsy (OBPP) and upper limb reduction deficiency, and for their parents. The scale is 0-100, with the higher score indicating better abilities.
Change in range of motion for shoulder, elbow, forearm, wrist, and fingers from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Time frame: pre treatment, immediate post treatment, and 3 month followup
1 secondary outcome
Change in motion analysis parameters from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Time frame: pre treatment, immediate post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Orthotic and Occupational Therapy in people with Cerebral Palsy, run by Rutgers, The State University of New Jersey 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 1 inclusion and 1 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 26 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Chu, MD (973 972 2076, chual@njms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Assisting Hand Assessment from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment (time frame: through study completion, an average of 6 months). The study lists 4 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 26 Dec 2023.