Cerebral Palsy
Conditions
Brief summary
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.
Interventions
DEVICERobotic 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
Sponsors
Northern Arizona University
Gillette Children's Specialty Healthcare
Shirley Ryan AbilityLab
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
BiOMOTUM, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Preferred Walking Speed | baseline and post intervention at 6 minutes | How fast someone prefers to walk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6MWT | 6 minutes pre/post | Change in Six-minute walk test, which is the total distance walked over a 6 minute period. |
| Change in Gait Kinetics | 6 minutes pre/post | Change in Average knee angle across stance phase measured in degrees |
| Change in COT | baseline and post intervention | Change in Metabolic cost of transport |
| Change in Gross Motor Function Measure Scale 66 | 20 minutes pre/post | 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. |
| Change in Fast Walking Speed | baseline and post intervention | How fast participants prefer to walk quickly (m/s) |
| Change in Step Length | baseline and post intervention | Step length during walking |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 19 |
| Total | 31 |
Baseline characteristics
| Characteristic | Therapist Supervised Assistance Training | Total | Therapist Supervised Resistance Training |
|---|---|---|---|
| Age, Continuous | 13.6 years STANDARD_DEVIATION 3.3 | 13.4 years STANDARD_DEVIATION 3.6 | 13.2 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 11 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 20 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) White | 6 Participants | 15 Participants | 9 Participants |
| Region of Enrollment United States | 12 participants | 31 participants | 19 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 16 |
| other Total, other adverse events | 3 / 12 | 0 / 16 |
| serious Total, serious adverse events | 0 / 12 | 0 / 16 |
Outcome results
Primary
Change in Preferred Walking Speed
How fast someone prefers to walk
Time frame: baseline and post intervention at 6 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapist Supervised Assistance Training | Change in Preferred Walking Speed | 0.09 m/s | Standard Deviation 0.13 |
| Therapist Supervised Resistance Training | Change in Preferred Walking Speed | 0.13 m/s | Standard Deviation 0.14 |
Secondary
Change in 6MWT
Change in Six-minute walk test, which is the total distance walked over a 6 minute period.
Time frame: 6 minutes pre/post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapist Supervised Assistance Training | Change in 6MWT | 46 m | Standard Deviation 53.7 |
| Therapist Supervised Resistance Training | Change in 6MWT | 48.4 m | Standard Deviation 74.2 |
Secondary
Change in COT
Change in Metabolic cost of transport
Time frame: baseline and post intervention
Population: 6 participants were unable to complete this outcomes measure test because of the metabolic face mask.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapist Supervised Assistance Training | Change in COT | -0.06 J/kg/m | Standard Deviation 0.13 |
| Therapist Supervised Resistance Training | Change in COT | -0.01 J/kg/m | Standard Deviation 0.11 |
Secondary
Change in Fast Walking Speed
How fast participants prefer to walk quickly (m/s)
Time frame: baseline and post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapist Supervised Assistance Training | Change in Fast Walking Speed | 0.06 m/s | Standard Deviation 0.18 |
| Therapist Supervised Resistance Training | Change in Fast Walking Speed | 0.18 m/s | Standard Deviation 0.21 |
Secondary
Change in Gait Kinetics
Change in Average knee angle across stance phase measured in degrees
Time frame: 6 minutes pre/post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapist Supervised Assistance Training | Change in Gait Kinetics | -1.62 degrees | Standard Deviation 2.05 |
| Therapist Supervised Resistance Training | Change in Gait Kinetics | -2.00 degrees | Standard Deviation 6.89 |
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.
Time frame: 20 minutes pre/post
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapist Supervised Assistance Training | Change in Gross Motor Function Measure Scale 66 | 1.43 scores on a scale | Standard Deviation 3.1 |
| Therapist Supervised Resistance Training | Change in Gross Motor Function Measure Scale 66 | 1.56 scores on a scale | Standard Deviation 2.032 |
Secondary
Change in Step Length
Step length during walking
Time frame: baseline and post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapist Supervised Assistance Training | Change in Step Length | 0.082 m | Standard Deviation 0.184 |
| Therapist Supervised Resistance Training | Change in Step Length | 0.072 m | Standard Deviation 0.142 |