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Augmenting Ankle Plantarflexor Function in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biomotum Spark: Robotic ankle assistance
Biomotum Spark: Robotic ankle resistance
Standard gait training
Ankle foot orthosis
Standard physical therapy
Standard walking
Sponsored by
Northern Arizona University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Gait, Rehabilitation

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages between 8 and 18 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.

Sites / Locations

  • Gillette Children's Specialty HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Device resisted gait training (treatment)

Standard gait training (control)

Comparison to Standard PT (within subjects control)

Device assisted ambulation

Passive brace assisted ambulation

No ankle aid ambulation

Arm Description

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.

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.

We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Outcomes

Primary Outcome Measures

Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Change in similarity of plantarflexor muscle activity
Similarity of the plantarflexor muscle activity profile across the gait cycle, measured using surface electromyography (the measurement tool) of the soleus muscle, to the average unimpaired electromyography muscle activity profile, as calculated via cross-correlation coefficient. A higher value indicates greater similarity.
Change in similarity of plantarflexor muscle activity
Similarity of the plantarflexor muscle activity profile across the gait cycle, measured using surface electromyography (the measurement tool) of the soleus muscle, to the average unimpaired electromyography muscle activity profile, as calculated via cross-correlation coefficient. A higher value indicates greater similarity.
Change in similarity of plantarflexor muscle activity
Similarity of the plantarflexor muscle activity profile across the gait cycle, measured using surface electromyography (the measurement tool) of the soleus muscle, to the average unimpaired electromyography muscle activity profile, as calculated via cross-correlation coefficient. A higher value indicates greater similarity.
Change in 6-minute-walk-test distance
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
Change in 6-minute-walk-test distance
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
Change in 6-minute-walk-test distance
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
Change in variance in muscle activity
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
Change in variance in muscle activity
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
Change in variance in muscle activity
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
Change in stride length
Participant stride length during walking. Longer stride length is desired.
Change in stride length
Participant stride length during walking. Longer stride length is desired.
Change in stride length
Participant stride length during walking. Longer stride length is desired.
Change in stride-to-stride variability stride length
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
Change in stride-to-stride variability stride length
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
Change in stride-to-stride variability stride length
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
Change in walking posture
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Change in walking posture
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Change in walking posture
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Change in Gross Motor Function Measure-66 sec. D&E
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
Change in Gross Motor Function Measure-66 sec. D&E
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
Change in Gross Motor Function Measure-66 sec. D&E
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
Change in plantar-flexor strength
Plantar-flexor muscle strength measured via hand-held dynamometry.
Change in plantar-flexor strength
Plantar-flexor muscle strength measured via hand-held dynamometry.
Change in plantar-flexor strength
Plantar-flexor muscle strength measured via hand-held dynamometry.
Distance traveled
Distance traveled during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols.
Metabolic cost of transport from indirect calorimetry
Metabolic cost estimated from a wearable indirect calorimetry system during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols
Subject perceived exertion
Subject perceived exertion (validated pictorial pediatric exertion scale). The scale is from 1-10, where a higher number indicates more effort.
Average muscle activity
Average stance-phase plantar flexor muscle activity assessed through surface electromyography of the soleus muscle.
Heart Rate
Average heart rate during each testing condition measured via chest-mounted heart rate monitor.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
July 20, 2023
Sponsor
Northern Arizona University
Collaborators
Gillette Children's Specialty Healthcare, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05154253
Brief Title
Augmenting Ankle Plantarflexor Function in Cerebral Palsy
Official Title
Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 8, 2026 (Anticipated)
Study Completion Date
September 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Arizona University
Collaborators
Gillette Children's Specialty Healthcare, University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A child's ability to walk effectively is essential to their physical health and general well-being. Unfortunately, many children with cerebral palsy (CP), the most common cause of pediatric physical disability, have difficulty walking and completing higher-intensity ambulatory tasks. This leads to children with CP engaging in levels of habitual physical activity that are well below guidelines and those of children without disabilities, which in turn contributes to many secondary conditions, including metabolic dysfunction and cardiovascular disease. There is broad clinical consensus that plantarflexor dysfunction is a primary contributor to slow, inefficient, and crouched walking patterns in CP; individuals with CP need more effective treatments and mobility aids for plantarflexor dysfunction. To meet this need, this proposal aims to evaluate a holistic strategy to address impaired mobility from plantarflexor dysfunction in CP using a lightweight, dual-mode (assistive or resistive) wearable robotic device. This strategy combines two complementary techniques: (1) targeted ankle resistance for neuromuscular gait training that provides precision therapy to elicit long-term improvements in ankle muscle function, and (2) adaptive ankle assistance to make walking easier during sustained, high-intensity, or challenging tasks. Aim 1: Quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with CP Approach - Repeated Measures (RM) and randomized controlled trial: The investigators will compare functional outcomes following targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard physical therapy (RM) and vs. dose-matched standard treadmill training (randomized controlled trial). Primary Hypothesis: 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 the control conditions. Aim 2: Determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP Approach - Repeated Measures: The investigators will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid) during (a) 6-minute-walk-test, (b) extended-duration over-ground walking (sustained), (c) graded treadmill (high-intensity), and (d) stair-stepping (challenging) protocols. Task capacity and performance will be measured by duration, metabolic cost, speed, and stride length, as applicable. Primary Hypothesis: Adaptive ankle assistance will result in significantly greater capacity and performance compared to the control conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Gait, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device resisted gait training (treatment)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard gait training (control)
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison to Standard PT (within subjects control)
Arm Type
Experimental
Arm Description
We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.
Arm Title
Device assisted ambulation
Arm Type
Experimental
Arm Description
We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
Arm Title
Passive brace assisted ambulation
Arm Type
Experimental
Arm Description
We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
Arm Title
No ankle aid ambulation
Arm Type
Experimental
Arm Description
We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).
Intervention Type
Device
Intervention Name(s)
Biomotum Spark: Robotic ankle assistance
Intervention Description
A lightweight assistive wearable ankle robotic device.
Intervention Type
Device
Intervention Name(s)
Biomotum Spark: Robotic ankle resistance
Intervention Description
A lightweight resistive wearable ankle robotic device.
Intervention Type
Other
Intervention Name(s)
Standard gait training
Intervention Description
Standard gait training without a device.
Intervention Type
Device
Intervention Name(s)
Ankle foot orthosis
Intervention Description
Standard ankle foot orthosis
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Intervention Description
Physical therapy without a device.
Intervention Type
Other
Intervention Name(s)
Standard walking
Intervention Description
Walking without a device
Primary Outcome Measure Information:
Title
Change in preferred walking speed
Description
Participant's preferred walking speed compared after to before the intervention
Time Frame
Immediately after the intervention
Title
Change in preferred walking speed
Description
Participant's preferred walking speed compared after to before the intervention
Time Frame
2 weeks after the intervention
Title
Change in preferred walking speed
Description
Participant's preferred walking speed compared after to before the intervention
Time Frame
12 weeks after the intervention
Title
Change in similarity of plantarflexor muscle activity
Description
Similarity of the plantarflexor muscle activity profile across the gait cycle, measured using surface electromyography (the measurement tool) of the soleus muscle, to the average unimpaired electromyography muscle activity profile, as calculated via cross-correlation coefficient. A higher value indicates greater similarity.
Time Frame
Immediately after the intervention
Title
Change in similarity of plantarflexor muscle activity
Description
Similarity of the plantarflexor muscle activity profile across the gait cycle, measured using surface electromyography (the measurement tool) of the soleus muscle, to the average unimpaired electromyography muscle activity profile, as calculated via cross-correlation coefficient. A higher value indicates greater similarity.
Time Frame
2 weeks after the intervention
Title
Change in similarity of plantarflexor muscle activity
Description
Similarity of the plantarflexor muscle activity profile across the gait cycle, measured using surface electromyography (the measurement tool) of the soleus muscle, to the average unimpaired electromyography muscle activity profile, as calculated via cross-correlation coefficient. A higher value indicates greater similarity.
Time Frame
12 weeks after the intervention
Title
Change in 6-minute-walk-test distance
Description
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
Time Frame
Immediately after the intervention
Title
Change in 6-minute-walk-test distance
Description
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
Time Frame
2 weeks after the intervention
Title
Change in 6-minute-walk-test distance
Description
Distance traveled in 6 minutes during a 6-minute-walk-test protocol. A longer distance indicates greater walking capacity.
Time Frame
12 weeks after the intervention
Title
Change in variance in muscle activity
Description
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
Time Frame
Immediately after the intervention
Title
Change in variance in muscle activity
Description
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
Time Frame
2 weeks after the intervention
Title
Change in variance in muscle activity
Description
Variance in muscle activity accounted for by one muscle synergy assessed using surface electromyography (the measurement tool) of the soleus, tibialis anterior, medial hamstrings, and vastus medialis. Muscle synergies will be computed from non-negative matrix factorization. Lower variance accounted for by one muscle synergy indicates a desired greater complexity of motor control.
Time Frame
12 weeks after the intervention
Title
Change in stride length
Description
Participant stride length during walking. Longer stride length is desired.
Time Frame
Immediately after the intervention
Title
Change in stride length
Description
Participant stride length during walking. Longer stride length is desired.
Time Frame
2 weeks after the intervention
Title
Change in stride length
Description
Participant stride length during walking. Longer stride length is desired.
Time Frame
12 weeks after the intervention
Title
Change in stride-to-stride variability stride length
Description
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
Time Frame
Immediately after the intervention
Title
Change in stride-to-stride variability stride length
Description
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
Time Frame
2 weeks after the intervention
Title
Change in stride-to-stride variability stride length
Description
Stride-to-stride variability of lower-extremity muscle activity for the soleus, tibias anterior, vastus lateralis, and medial hamstrings, measured via surface electromyography and calculated as the variance ratio across strides.
Time Frame
12 weeks after the intervention
Title
Change in walking posture
Description
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Time Frame
Immediately after the intervention
Title
Change in walking posture
Description
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Time Frame
2 weeks after the intervention
Title
Change in walking posture
Description
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Time Frame
12 weeks after the intervention
Title
Change in Gross Motor Function Measure-66 sec. D&E
Description
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
Time Frame
Immediately after the intervention
Title
Change in Gross Motor Function Measure-66 sec. D&E
Description
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
Time Frame
2 weeks after the intervention
Title
Change in Gross Motor Function Measure-66 sec. D&E
Description
Gross Motor Function Measure - 66, sections (D) standing, and (E) walking, running and jumping. Higher scores are better, and range from 0-3 for each measure.
Time Frame
12 weeks after the intervention
Title
Change in plantar-flexor strength
Description
Plantar-flexor muscle strength measured via hand-held dynamometry.
Time Frame
Immediately after the intervention
Title
Change in plantar-flexor strength
Description
Plantar-flexor muscle strength measured via hand-held dynamometry.
Time Frame
2 weeks after the intervention
Title
Change in plantar-flexor strength
Description
Plantar-flexor muscle strength measured via hand-held dynamometry.
Time Frame
12 weeks after the intervention
Title
Distance traveled
Description
Distance traveled during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols.
Time Frame
1 day
Title
Metabolic cost of transport from indirect calorimetry
Description
Metabolic cost estimated from a wearable indirect calorimetry system during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols
Time Frame
1 day
Title
Subject perceived exertion
Description
Subject perceived exertion (validated pictorial pediatric exertion scale). The scale is from 1-10, where a higher number indicates more effort.
Time Frame
1 day
Title
Average muscle activity
Description
Average stance-phase plantar flexor muscle activity assessed through surface electromyography of the soleus muscle.
Time Frame
1 day
Title
Heart Rate
Description
Average heart rate during each testing condition measured via chest-mounted heart rate monitor.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages between 8 and 18 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zach Lerner, PhD
Phone
928-523-1787
Email
zachary.lerner@nau.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zach F Lerner, PhD
Organizational Affiliation
Northern Arizona University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gillette Children's Specialty Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Schwartz, PhD
Phone
651-229-3929
Email
MSchwartz@gillettechildrens.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Augmenting Ankle Plantarflexor Function in Cerebral Palsy

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