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| Name | Class |
|---|---|
| Northern Arizona University | OTHER |
| Gillette Children's Specialty Healthcare | OTHER |
| Shirley Ryan AbilityLab | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy.
The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention.
The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention.
Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapist supervised assistance training | Experimental | Assistance training with the RAAD under therapist supervision. |
|
| Therapist supervised resistance training | Experimental | Resistance training with the RAAD under therapist supervision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Ankle Assist Device (RAAD) | Device | The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Preferred Walking Speed | How fast someone prefers to walk | baseline and post intervention at 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in COT | Change in Metabolic cost of transport | baseline and post intervention |
| Change in 6MWT | Change in Six-minute walk test, which is the total distance walked over a 6 minute period. |
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Inclusion Criteria:
Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.
Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.
Exclusion Criteria:
Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.
Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.
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| Name | Affiliation | Role |
|---|---|---|
| Ray Browning, PhD | BiOMOTUM, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Arizona University | Flagstaff | Arizona | 86011 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapist Supervised Assistance Training | One group of participants were recruited to complete assistance training with the RAAD under therapist supervision. Robotic Ankle Assist Device (RAAD): The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP |
| FG001 | Therapist Supervised Resistance Training | A second group of participants were recruited to complete resistance training with the RAAD under therapist supervision. Robotic Ankle Assist Device (RAAD): The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapist Supervised Assistance Training | Assistance training with the RAAD under therapist supervision. Robotic Ankle Assist Device (RAAD): The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Preferred Walking Speed | How fast someone prefers to walk | Posted | Mean | Standard Deviation | m/s | baseline and post intervention at 6 minutes |
|
During the protocol, approximately 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapist Supervised Assistance Training | Assistance training with the RAAD under therapist supervision. Robotic Ankle Assist Device (RAAD): The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | fall | Non-systematic Assessment | A fall during the walking protocol |
Some participants were unable to complete all assessment tests leading to small sample sizes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Science Officer | Biomotum | (800) 566-2531 | zach@biomotum.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2024 | Feb 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2025 | Mar 25, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2024 | Feb 6, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| NIH |
This study has two experiments. In experiment I, participants will be recruited to complete gait training with the RAAD under assistance mode. In experiment two, participants will be recruited to complete gait training with the RAAD under resistance mode.
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| 6 minutes pre/post |
| Change in Gait Kinetics | Change in Average knee angle across stance phase measured in degrees | 6 minutes pre/post |
| Change in Step Length | Step length during walking | baseline and post intervention |
| Change in Gross Motor Function Measure Scale 66 | Change in Gross motor function measure scale 66, min score = 0, max score = 66, high score is better. Unit of measure = Scores on a scale. | 20 minutes pre/post |
| Change in Fast Walking Speed | How fast participants prefer to walk quickly (m/s) | baseline and post intervention |
| BG001 |
| Therapist Supervised Resistance Training |
Resistance training with the RAAD under therapist supervision. Robotic Ankle Assist Device (RAAD): The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Change in COT | Change in Metabolic cost of transport | 6 participants were unable to complete this outcomes measure test because of the metabolic face mask. | Posted | Mean | Standard Deviation | J/kg/m | baseline and post intervention |
|
|
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| Secondary | Change in 6MWT | Change in Six-minute walk test, which is the total distance walked over a 6 minute period. | Posted | Mean | Standard Deviation | m | 6 minutes pre/post |
|
|
|
| Secondary | Change in Gait Kinetics | Change in Average knee angle across stance phase measured in degrees | Posted | Mean | Standard Deviation | degrees | 6 minutes pre/post |
|
|
|
| Secondary | Change in Step Length | Step length during walking | Posted | Mean | Standard Deviation | m | baseline and post intervention |
|
|
|
| Secondary | Change in Gross Motor Function Measure Scale 66 | Change in Gross motor function measure scale 66, min score = 0, max score = 66, high score is better. Unit of measure = Scores on a scale. | Posted | Mean | Standard Deviation | scores on a scale | 20 minutes pre/post |
|
|
|
| Secondary | Change in Fast Walking Speed | How fast participants prefer to walk quickly (m/s) | Posted | Mean | Standard Deviation | m/s | baseline and post intervention |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Therapist Supervised Resistance Training | Resistance training with the RAAD under therapist supervision. Robotic Ankle Assist Device (RAAD): The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP | 0 | 16 | 0 | 16 | 0 | 16 |
|
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