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NCT05154253 · ClinicalTrials.gov registry record · Phase 1
Augmenting Ankle Plantarflexor Function in Cerebral Palsy
A Phase 1 study of Cerebral Palsy, sponsored by Northern Arizona University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05154253: Recruiting Phase 1 study of Cerebral Palsy, sponsored by Northern Arizona University.
NCT05154253 is a Phase 1 study of Cerebral Palsy that is actively recruiting participants, run by Northern Arizona University. The registered enrollment target is 36 participants, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05154253, a Phase 1 study of Cerebral Palsy, is actively recruiting participants, sponsored by Northern Arizona University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The first specific aim is to quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with cerebral palsy (CP). The primary hypothesis for the first aim is that targeted ankle resistance training will produce larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility assessed four- and twelve-weeks post intervention compared to standard physical therapy and standard gait training. The second specific aim is to determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP. The primary hypothesis for the second aim is that adaptive ankle assistance will result in significantly greater capacity and performance during the six-minute-walk-test and graded treadmill and stair stepping protocols compared to walking with ankle foot orthoses and walking with just shoes.
Primary Outcome
Participant's preferred walking speed compared after to before the intervention
Conditions Studied
Interventions
- OTHER Standard physical therapy
- DEVICE Biomotum Spark: Robotic ankle assistance
- DEVICE Biomotum Spark: Robotic ankle resistance
- OTHER Standard gait training
- DEVICE Ankle foot orthosis
Study Locations (1)
Minnesota
- Gillette Children's Specialty Healthcare - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2026-09-25 |
| Phase | Phase 1 |
What NCT05154253 shows while recruiting
NCT05154253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Cerebral Palsy appearing as the primary indexed condition, and to 5 interventions - of which Standard physical therapy is the first listed.
NCT05154253 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05154253 about?
NCT05154253 is a clinical study titled "Augmenting Ankle Plantarflexor Function in Cerebral Palsy". The first specific aim is to quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with cerebral palsy (CP). The primary hypothesis for the first aim is that targeted ankle resistance training will produce large...
What is the current status of trial NCT05154253?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-02-01. Estimated completion is 2026-09-25.
What conditions does trial NCT05154253 study?
This clinical trial studies the following conditions: Cerebral Palsy.
What interventions are being tested in trial NCT05154253?
The interventions under investigation include: Standard physical therapy (OTHER), Biomotum Spark: Robotic ankle assistance (DEVICE), Biomotum Spark: Robotic ankle resistance (DEVICE), Standard gait training (OTHER), Ankle foot orthosis (DEVICE).
Who is sponsoring clinical trial NCT05154253?
This trial is sponsored by Northern Arizona University, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05154253 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cerebral Palsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05154253's enrollment target sits among peer trials
36 46th of 91 higher than 43 of 91 other Cerebral Palsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cerebral Palsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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