Augmenting Ankle Plantarflexor Function in Cerebral Palsy

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Northern Arizona University
Study ID
NCT05154253
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
8 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Biomotum Spark: Robotic ankle assistance — DEVICE
    A lightweight assistive wearable ankle robotic device.
  • Biomotum Spark: Robotic ankle resistance — DEVICE
    A lightweight resistive wearable ankle robotic device.
  • Standard gait training — OTHER
    Standard gait training without a device.
  • Ankle foot orthosis — DEVICE
    Standard ankle foot orthosis
  • Standard physical therapy — OTHER
    Physical therapy without a device.
  • Standard walking — OTHER
    Walking without a device

Study Details

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.

Key Dates

Start date
Feb 1, 2023
Status verified
Feb 2026
Primary completion
Sep 14, 2026
Completion
Sep 25, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Device resisted gait training (treatment)
    We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.
  • Experimental: Standard gait training (control)
    We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.
  • Experimental: Comparison to Standard PT (within subjects control)
    We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.
  • Experimental: Device assisted ambulation
    We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
  • Experimental: Passive brace assisted ambulation
    We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
  • Experimental: No ankle aid ambulation
    We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Primary Outcome Measure

Change in preferred walking speed [ Time Frame: Immediately after the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gillette Children's Specialty HealthcareMinneapolisMinnesota55101
Mike Schwartz, PhD
[email protected]
651-229-3929

Find similar trials in Minneapolis, MN

By research site
Gillette Children's Specialty Healthcare· Minneapolis, MN

Related Studies