Cerebral PalsyPhase 1NCT05154253
Augmenting Ankle Plantarflexor Function in Cerebral Palsy
A Phase 1 study testing Biomotum Spark: Robotic ankle assistance, Biomotum Spark: Robotic ankle resistance and Standard gait training in people with Cerebral Palsy, run by Northern Arizona University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Biomotum Spark: Robotic ankle assistance, Biomotum Spark: Robotic ankle resistance and Standard gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 25 Sep 2026
- Phase
- Phase 1
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
Gillette Children's Specialty Healthcare
Minneapolis, Minnesota, 55101
Mike Schwartz, PhD, 651-229-3929, MSchwartz@gillettechildrens.com
About this study
Official title: Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With 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 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Biomotum Spark: Robotic ankle assistance, Biomotum Spark: Robotic ankle resistance, Standard gait training, Ankle foot orthosis, Standard physical therapy
- Keywords
- Gait, Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomotum Spark: Robotic ankle assistanceDevice
A lightweight assistive wearable ankle robotic device.
Biomotum Spark: Robotic ankle resistanceDevice
A lightweight resistive wearable ankle robotic device.
Standard gait trainingOther
Standard gait training without a device.
Ankle foot orthosisDevice
Standard ankle foot orthosis
Standard physical therapyOther
Physical therapy without a device.
Standard walkingOther
Walking without a device
| Study group | Role | What they receive |
|---|---|---|
| Device resisted gait training (treatment) | Experimental | 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. Receives: Device: Biomotum Spark: Robotic ankle resistance |
| Standard gait training (control) | Experimental | 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. Receives: Other: Standard gait training |
| Comparison to Standard PT (within subjects control) | Experimental | We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy. Receives: Other: Standard physical therapy |
| Device assisted ambulation | Experimental | We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid). Receives: Device: Biomotum Spark: Robotic ankle assistance |
| Passive brace assisted ambulation | Experimental | We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid). Receives: Device: Ankle foot orthosis |
| No ankle aid ambulation | Experimental | We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid). Receives: Other: Standard walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Measured: Immediately after the intervention
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Measured: 2 weeks after the intervention
Change in preferred walking speed
Participant's preferred walking speed compared after to before the intervention
Measured: 12 weeks after 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.
Measured: Immediately after 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.
Measured: 2 weeks after 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.
Measured: 12 weeks after the intervention
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.
Measured: Immediately after the intervention
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.
Measured: 2 weeks after the intervention
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.
Measured: 12 weeks after the intervention
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.
Measured: Immediately after the intervention
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.
Measured: 2 weeks after the intervention
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.
Measured: 12 weeks after the intervention
Change in stride length
Participant stride length during walking. Longer stride length is desired.
Measured: Immediately after the intervention
Change in stride length
Participant stride length during walking. Longer stride length is desired.
Measured: 2 weeks after the intervention
Change in stride length
Participant stride length during walking. Longer stride length is desired.
Measured: 12 weeks after the intervention
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.
Measured: Immediately after the intervention
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.
Measured: 2 weeks after the intervention
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.
Measured: 12 weeks after the intervention
Change in walking posture
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Measured: Immediately after the intervention
Change in walking posture
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Measured: 2 weeks after the intervention
Change in walking posture
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Measured: 12 weeks after the intervention
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.
Measured: Immediately after the intervention
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.
Measured: 2 weeks after the intervention
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.
Measured: 12 weeks after the intervention
Change in plantar-flexor strength
Plantar-flexor muscle strength measured via hand-held dynamometry.
Measured: Immediately after the intervention
Change in plantar-flexor strength
Plantar-flexor muscle strength measured via hand-held dynamometry.
Measured: 2 weeks after the intervention
Change in plantar-flexor strength
Plantar-flexor muscle strength measured via hand-held dynamometry.
Measured: 12 weeks after the intervention
Distance traveled
Distance traveled during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols.
Measured: 1 day
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
Measured: 1 day
Subject perceived exertion
Subject perceived exertion (validated pictorial pediatric exertion scale). The scale is from 1-10, where a higher number indicates more effort.
Measured: 1 day
Average muscle activity
Average stance-phase plantar flexor muscle activity assessed through surface electromyography of the soleus muscle.
Measured: 1 day
Heart Rate
Average heart rate during each testing condition measured via chest-mounted heart rate monitor.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Feb 2023
- Primary completion14 Sep 2026 (estimated)
- Study completion25 Sep 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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- Gillette Children's Specialty Healthcare, University of Washington
- Responsible party
- Sponsor
- Investigators
- Zach F Lerner, PhD, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154253
- Sponsor's protocol ID
- 1R01HD107277
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05154253
- Acronym / sponsor ID
- 1R01HD107277
- Conditions
- Cerebral Palsy
- Keywords
- Gait, Rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- Gillette Children's Specialty Healthcare, University of Washington
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 14 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 13 Dec 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Device resisted gait training (treatment) | Experimental | Device: Biomotum Spark: Robotic ankle resistanceWe 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. |
| Standard gait training (control) | Experimental | Other: Standard gait trainingWe 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. |
| Comparison to Standard PT (within subjects control) | Experimental | Other: Standard physical therapyWe will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy. |
| Device assisted ambulation | Experimental | Device: Biomotum Spark: Robotic ankle assistanceWe will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid). |
| Passive brace assisted ambulation | Experimental | Device: Ankle foot orthosisWe will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid). |
| No ankle aid ambulation | Experimental | Other: Standard walkingWe will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid). |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Biomotum Spark: Robotic ankle assistanceA lightweight assistive wearable ankle robotic device. | Device | Device assisted ambulation |
| Biomotum Spark: Robotic ankle resistanceA lightweight resistive wearable ankle robotic device. | Device | Device resisted gait training (treatment) |
| Standard gait trainingStandard gait training without a device. | Other | Standard gait training (control) |
| Ankle foot orthosisStandard ankle foot orthosis | Device | Passive brace assisted ambulation |
| Standard physical therapyPhysical therapy without a device. | Other | Comparison to Standard PT (within subjects control) |
| Standard walkingWalking without a device | Other | No ankle aid ambulation |
Primary outcome
Change in preferred walking speed
Time frame: Immediately after the intervention
Participant's preferred walking speed compared after to before the intervention
Change in preferred walking speed
Time frame: 2 weeks after the intervention
Participant's preferred walking speed compared after to before the intervention
Change in preferred walking speed
Time frame: 12 weeks after the intervention
Participant's preferred walking speed compared after to before the intervention
Change in similarity of plantarflexor muscle activity
Time frame: Immediately after the intervention
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
Time frame: 2 weeks after the intervention
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
Time frame: 12 weeks after the intervention
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
Time frame: Immediately after the intervention
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
Time frame: 2 weeks after the intervention
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
Time frame: 12 weeks after the intervention
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
Time frame: Immediately after the intervention
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
Time frame: 2 weeks after the intervention
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
Time frame: 12 weeks after the intervention
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
Time frame: Immediately after the intervention
Participant stride length during walking. Longer stride length is desired.
Change in stride length
Time frame: 2 weeks after the intervention
Participant stride length during walking. Longer stride length is desired.
Change in stride length
Time frame: 12 weeks after the intervention
Participant stride length during walking. Longer stride length is desired.
Change in stride-to-stride variability stride length
Time frame: Immediately after the intervention
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
Time frame: 2 weeks after the intervention
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
Time frame: 12 weeks after the intervention
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
Time frame: Immediately after the intervention
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Change in walking posture
Time frame: 2 weeks after the intervention
Peak Lower-extremity joint angles summed across the ankle, knee, and hip joints, measured using motion capture (the measurement tool).
Change in walking posture
Time frame: 12 weeks after the intervention
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
Time frame: Immediately after the intervention
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
Time frame: 2 weeks after the intervention
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
Time frame: 12 weeks after the intervention
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
Time frame: Immediately after the intervention
Plantar-flexor muscle strength measured via hand-held dynamometry.
Change in plantar-flexor strength
Time frame: 2 weeks after the intervention
Plantar-flexor muscle strength measured via hand-held dynamometry.
Change in plantar-flexor strength
Time frame: 12 weeks after the intervention
Plantar-flexor muscle strength measured via hand-held dynamometry.
Distance traveled
Time frame: 1 day
Distance traveled during the 6-minute-walk-test, and treadmill and stair stepper bruce protocols.
Metabolic cost of transport from indirect calorimetry
Time frame: 1 day
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
Time frame: 1 day
Subject perceived exertion (validated pictorial pediatric exertion scale). The scale is from 1-10, where a higher number indicates more effort.
Average muscle activity
Time frame: 1 day
Average stance-phase plantar flexor muscle activity assessed through surface electromyography of the soleus muscle.
Heart Rate
Time frame: 1 day
Average heart rate during each testing condition measured via chest-mounted heart rate monitor.
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 3 Mar 2026.
- 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.
Zach F Lerner, PhD principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biomotum Spark: Robotic ankle assistance, Biomotum Spark: Robotic ankle resistance and Standard gait training in people with Cerebral Palsy, run by Northern Arizona University 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 3 inclusion and 3 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 3 Mar 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zach Lerner, PhD (928-523-1787, zachary.lerner@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in preferred walking speed (time frame: Immediately after the intervention). The study lists 32 primary outcomes in all. 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 3 Mar 2026.