Cerebral PalsyNCT05781438
Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy
A study testing In-home standing and walking intervention in people with Cerebral Palsy, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 months to 2 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- In-home standing and walking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2023to 31 Dec 2026
- 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 5 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with or at high risk of cerebral palsy (CP) who either:
- have been diagnosed with CP by a medical professional, or
- are at high risk of CP defined as having both:
- clinical brain imaging indicating CP, such as (i) white matter injury (cystic periventricular leukomalacia or periventricular hemorrhagic infarctions), (ii) hypoxic-ischemic encephalopathy, or (iii) neonatal stroke, and
- a score less than 63 or more than 5 asymmetries on the Hammersmith Infant Neurological Examination (HINE).
Who cannot join
- prenatal substance abuse,
- congenital malformations,
- drug-resistant epilepsy,
- visual impairment that hinders the infant from seeing toys,
- hearing impairment that hinders the infant from responding to sound,
- living in a location inaccessible by study personnel for in-home data collections,
- participant over 50 lbs in weight.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Barbara Sargent, PT, PhD, 323-442-4823, bsargent@pt.usc.edu
Stacey Dusing, PT, PhD, 323-442-1022, Stacey.dusing@pt.usc.edu
About this study
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of cerebral palsy.
Read the detailed description
Seventy percent of children with cerebral palsy (CP) will walk, yet walking occurs much later than typically-developing children and may require use of a walker or crutches. The walking impairment is caused by an early lesion to the motor areas of the brain which disrupts the formation of appropriate neural connections, specifically projections of the corticospinal tract from the motor cortex to spinal cord motor circuits. The critical period of lower extremity neuromotor development, when intervention is expected to be most effective, begins before 12 months of age with the establishment of appropriate spinal connections and extends to 2 years of age with the presence of mature myelin in the corticospinal tract at the lumbar level. Based on this research, we propose that to optimize future walking outcomes of individuals with CP, it is critical to promote standing and walking practice during infancy before the age of 12 months.
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of CP. Eight infants with or at high risk of CP will enter the study at 5 to 12-months of age. All infants will participate in 3 conditions: 8-weeks no intervention baseline, 16-weeks intervention, and 8-weeks no intervention follow-up. During the intervention weeks, parents will implement the in-home intensive standing and walking intervention with body-weight support 5 days/week for 30-60 min/day, with weekly telehealth calls and monthly home visits to progress the program. The body-weight support system allows infants to independently explore a 9 by 9-foot space in standing without physical assist from their parents or other adults.
Outcomes will be measured at baseline, monthly throughout the 8 month study, and at 2 years of age. Feasibility of implementing the interventions will be assessed. Secondary outcomes will include standardized assessments of motor, cognitive, and language development of the infants.
- Conditions
- Cerebral Palsy
- Being tested
- In-home standing and walking intervention
- Keywords
- Infant
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home standing and walking interventionBehavioural
Parents/legal guardians will be educated on and provided an activity booklet on intensive standing and walking play activities for their infant in a 9 by 9 foot body-weight support system (BWS). Activities include: squatting play at a couch or table, cruising along and between furniture, walking with a push toy or with one or two hands held, walking without support, and kicking and throwing a soft ball.
For 16 weeks, parents/legal guardians will be encouraged to implement the parent-led, intensive standing and walking intervention using BWS for at least 5 days/week for 30-60 min/day, with weekly telehealth calls and monthly home visits to coach parents in identifying key activities and progressing the program.
| Study group | Role | What they receive |
|---|---|---|
| In-home standing and walking intervention | Experimental | Infants will participate in the in-home standing and walking intervention for 16 weeks. In addition, infants will continue with any intervention in the community recommended by their health care team. Receives: Behavioral: In-home standing and walking intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the in-home standing and walking intervention
Feasibility will be quantified by: parent survey of the: (a) infants' level of enjoyment during the intervention, (b) ease of use of the body-weight support system, (c) time participating in intervention, (d) time to put child in and take child out of the body-weight support, (e) perception of the effect of the intervention on the infant's motor skills, (f) perception of the effects of the intervention on the infant's non-motor skills (cognition, social, language), (g) overall perception of intervention as beneficial. The parent survey is on a likert scale from 1 to 5; a higher score denotes a better outcome.
Measured: 4 months
Secondary outcomes (2)
Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4)
The Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4) is a standardized developmental assessment that provides raw scores for 5 subtests (cognitive, expressive communication, receptive communication, fine motor, gross motor) and standard score norms converted to percentiles for 3 scales (cognition, communication, motor). The Bayley-4 raw scores range from 0-162 for the cognitive subtest, 0-84 for the receptive communication subtest, 0-74 for the expressive communication subtest, 0-92 for the fine motor subtest, and 0-116 for the gross motor subtest; a higher score denotes a better outcome. The Bayley-4 standard score norms are converted to percentiles from <0.1 to >99.9 for the cognitive, language, and motor scales; a higher percentile denotes a better outcome.
Measured: 2 years
Gross Motor Function Measure (GMFM-88)
The Gross Motor Function Measure (GMFM-88) is a standardized motor assessment designed to assess gross motor function of children with cerebral palsy. The GMFM-88 raw scores range from 0-51 for the lying and rolling subtest, 0-60 for the sitting subtest, 0-42 for the crawling and kneeling subtest, 0-39 for the standing subtest, and 0-72 for the walking, running and jumping subtest; a higher score denotes a better outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start26 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by University of Southern CaliforniaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject research design
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- California Physical Therapy Association, Cerebral Palsy Foundation
- Responsible party
- Principal investigator, Barbara Sargent, University of Southern California
- Investigators
- Barbara Sargent, PhD, PT, Principal investigator, University of Southern California, Division of Biokinesiology and Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781438
- Sponsor's protocol ID
- UP-22-00866
- Status last verified
- Jun 2025
- First submitted
- 31 Dec 2022
- Last updated
- 26 Jun 2025
- 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 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05781438
- Acronym / sponsor ID
- UP-22-00866
- Conditions
- Cerebral Palsy
- Keywords
- Infant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- California Physical Therapy Association, Cerebral Palsy Foundation
- Study start
- 26 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 2023 (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 evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of cerebral palsy.
Detailed description
Seventy percent of children with cerebral palsy (CP) will walk, yet walking occurs much later than typically-developing children and may require use of a walker or crutches. The walking impairment is caused by an early lesion to the motor areas of the brain which disrupts the formation of appropriate neural connections, specifically projections of the corticospinal tract from the motor cortex to spinal cord motor circuits. The critical period of lower extremity neuromotor development, when intervention is expected to be most effective, begins before 12 months of age with the establishment of appropriate spinal connections and extends to 2 years of age with the presence of mature myelin in the corticospinal tract at the lumbar level. Based on this research, we propose that to optimize future walking outcomes of individuals with CP, it is critical to promote standing and walking practice during infancy before the age of 12 months.
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of CP. Eight infants with or at high risk of CP will enter the study at 5 to 12-months of age. All infants will participate in 3 conditions: 8-weeks no intervention baseline, 16-weeks intervention, and 8-weeks no intervention follow-up. During the intervention weeks, parents will implement the in-home intensive standing and walking intervention with body-weight support 5 days/week for 30-60 min/day, with weekly telehealth calls and monthly home visits to progress the program. The body-weight support system allows infants to independently explore a 9 by 9-foot space in standing without physical assist from their parents or other adults.
Outcomes will be measured at baseline, monthly throughout the 8 month study, and at 2 years of age. Feasibility of implementing the interventions will be assessed. Secondary outcomes will include standardized assessments of motor, cognitive, and language development of the infants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject research design
| Arm | Type | Receives |
|---|---|---|
| In-home standing and walking intervention | Experimental | Behavioral: In-home standing and walking interventionInfants will participate in the in-home standing and walking intervention for 16 weeks. In addition, infants will continue with any intervention in the community recommended by their health care team. |
Who may qualify
- Ages
- 5 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants with or at high risk of cerebral palsy (CP) who either:
Key exclusion criteria (7 listed)
- prenatal substance abuse,
- congenital malformations,
- drug-resistant epilepsy,
- visual impairment that hinders the infant from seeing toys,
- hearing impairment that hinders the infant from responding to sound,
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 |
|---|---|---|
| In-home standing and walking interventionParents/legal guardians will be educated on and provided an activity booklet on intensive standing and walking play activities for their infant in a 9 by 9 foot body-weight support system (BWS). Activities include: squatting play at a couch or table, cruising along and between furniture, walking with a push toy or with one or two hands held, walking without support, and kicking and throwing a soft ball. For 16 weeks, parents/legal guardians will be encouraged to implement the parent-led, intensive standing and walking intervention using BWS for at least 5 days/week for 30-60 min/day, with weekly telehealth calls and monthly home visits to coach parents in identifying key activities and progressing the program. | Behavioural | In-home standing and walking intervention |
Primary outcome
Feasibility of the in-home standing and walking intervention
Time frame: 4 months
Feasibility will be quantified by: parent survey of the: (a) infants' level of enjoyment during the intervention, (b) ease of use of the body-weight support system, (c) time participating in intervention, (d) time to put child in and take child out of the body-weight support, (e) perception of the effect of the intervention on the infant's motor skills, (f) perception of the effects of the intervention on the infant's non-motor skills (cognition, social, language), (g) overall perception of intervention as beneficial. The parent survey is on a likert scale from 1 to 5; a higher score denotes a better outcome.
2 secondary outcomes
Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4)
Time frame: 2 years
Gross Motor Function Measure (GMFM-88)
Time frame: 2 years
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 26 Jun 2025.
- 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.
Barbara Sargent, PhD, PT principal investigator
University of Southern California, Division of Biokinesiology and Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-home standing and walking intervention in people with Cerebral Palsy, run by University of Southern California 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 5 inclusion and 7 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 26 Jun 2025. 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 Barbara Sargent, PhD, PT (323-442-4823, bsargent@pt.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the in-home standing and walking intervention (time frame: 4 months). 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 Jun 2025.