Recruiting
Phase 1

Ankle Resistance Training

Sponsor:

Northern Arizona University

Code:

NCT05154253

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Interventions

Biomotum Spark: Robotic ankle assistance

Biomotum Spark: Robotic ankle resistance

Standard gait training

Ankle foot orthosis

Standard physical therapy

Study Details

Brief 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.

Conditions

Cerebral Palsy

Study ID

NCT05154253

Start date

Feb 1, 2023

Status verified date

Feb, 2026

Completion date

Sep 25, 2026

Anticipated

Primary completion date

Sep 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages between 8 and 21 years old, inclusive. Diagnosis of CP and a pathological gait pattern caused by ankle dysfunction.
  • Able to understand and follow simple directions (based on parent report, if needed) and walk at least 30 feet with or without a walking aid (Gross Motor Function Classification System (GMFCS) Level I-III).
  • At least 20° of passive plantar-flexion range of motion.

Exclusion Criteria:

  • Concurrent treatment other than those assigned during the study.
  • A condition other than CP that would affect safe participation.
  • Surgical intervention within 6 months of participation.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Biomotum Spark: Robotic ankle assistance

A lightweight assistive wearable ankle robotic device.

Biomotum Spark: Robotic ankle resistance

A lightweight resistive wearable ankle robotic device.

Standard gait training

Standard gait training without a device.

Ankle foot orthosis

Standard ankle foot orthosis

Standard physical therapy

Physical therapy without a device.

Standard walking

Walking without a device

Primary outcome measure

  • Change in preferred walking speed [ Time Frame: Immediately after the intervention ]
  • Change in preferred walking speed [ Time Frame: 2 weeks after the intervention ]
  • Change in preferred walking speed [ Time Frame: 12 weeks after the intervention ]
  • Change in similarity of plantarflexor muscle activity [ Time Frame: Immediately after the intervention ]
  • Change in similarity of plantarflexor muscle activity [ Time Frame: 2 weeks after the intervention ]
  • Change in similarity of plantarflexor muscle activity [ Time Frame: 12 weeks after the intervention ]
  • Change in 6-minute-walk-test distance [ Time Frame: Immediately after the intervention ]
  • Change in 6-minute-walk-test distance [ Time Frame: 2 weeks after the intervention ]
  • Change in 6-minute-walk-test distance [ Time Frame: 12 weeks after the intervention ]
  • Change in variance in muscle activity [ Time Frame: Immediately after the intervention ]
  • Change in variance in muscle activity [ Time Frame: 2 weeks after the intervention ]
  • Change in variance in muscle activity [ Time Frame: 12 weeks after the intervention ]
  • Change in stride length [ Time Frame: Immediately after the intervention ]
  • Change in stride length [ Time Frame: 2 weeks after the intervention ]
  • Change in stride length [ Time Frame: 12 weeks after the intervention ]
  • Change in stride-to-stride variability stride length [ Time Frame: Immediately after the intervention ]
  • Change in stride-to-stride variability stride length [ Time Frame: 2 weeks after the intervention ]
  • Change in stride-to-stride variability stride length [ Time Frame: 12 weeks after the intervention ]
  • Change in walking posture [ Time Frame: Immediately after the intervention ]
  • Change in walking posture [ Time Frame: 2 weeks after the intervention ]
  • Change in walking posture [ Time Frame: 12 weeks after the intervention ]
  • Change in Gross Motor Function Measure-66 sec. D&E [ Time Frame: Immediately after the intervention ]
  • Change in Gross Motor Function Measure-66 sec. D&E [ Time Frame: 2 weeks after the intervention ]
  • Change in Gross Motor Function Measure-66 sec. D&E [ Time Frame: 12 weeks after the intervention ]
  • Change in plantar-flexor strength [ Time Frame: Immediately after the intervention ]
  • Change in plantar-flexor strength [ Time Frame: 2 weeks after the intervention ]
  • Change in plantar-flexor strength [ Time Frame: 12 weeks after the intervention ]
  • Distance traveled [ Time Frame: 1 day ]
  • Metabolic cost of transport from indirect calorimetry [ Time Frame: 1 day ]
  • Subject perceived exertion [ Time Frame: 1 day ]
  • Average muscle activity [ Time Frame: 1 day ]
  • Heart Rate [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Zach Lerner, PhD

928-523-1787zachary.lerner@nau.edu

Locations

Gillette Children's Specialty Healthcare

Recruiting

Minneapolis, Minnesota, United States, 55101

Contacts

Mike Schwartz, PhD

651-229-3929MSchwartz@gillettechildrens.com

More Information

Sponsor

Northern Arizona University

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • Gait
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northern Arizona University on 2026-03-03.