Trial Outcomes & Findings for Development of a Robotic Ankle Assist Device (NCT NCT04516343)
NCT ID: NCT04516343
Last Updated: 2025-04-04
Results Overview
How fast someone prefers to walk
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
baseline and post intervention at 6 minutes
Results posted on
2025-04-04
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
19
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Robotic Ankle Assist Device
Baseline characteristics by cohort
| Measure |
Therapist Supervised Assistance Training
n=12 Participants
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
|
Therapist Supervised Resistance Training
n=19 Participants
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
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.6 years
STANDARD_DEVIATION 3.3 • n=99 Participants
|
13.2 years
STANDARD_DEVIATION 3.9 • n=107 Participants
|
13.4 years
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
19 participants
n=107 Participants
|
31 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and post intervention at 6 minutesHow fast someone prefers to walk
Outcome measures
| Measure |
Therapist Supervised Assistance Training
n=12 Participants
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
|
Therapist Supervised Resistance Training
n=16 Participants
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
|
|---|---|---|
|
Change in Preferred Walking Speed
|
0.09 m/s
Standard Deviation 0.13
|
0.13 m/s
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: baseline and post interventionPopulation: 6 participants were unable to complete this outcomes measure test because of the metabolic face mask.
Change in Metabolic cost of transport
Outcome measures
| Measure |
Therapist Supervised Assistance Training
n=12 Participants
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
|
Therapist Supervised Resistance Training
n=10 Participants
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
|
|---|---|---|
|
Change in COT
|
-0.06 J/kg/m
Standard Deviation 0.13
|
-0.01 J/kg/m
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 6 minutes pre/postChange in Six-minute walk test, which is the total distance walked over a 6 minute period.
Outcome measures
| Measure |
Therapist Supervised Assistance Training
n=12 Participants
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
|
Therapist Supervised Resistance Training
n=16 Participants
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
|
|---|---|---|
|
Change in 6MWT
|
46 m
Standard Deviation 53.7
|
48.4 m
Standard Deviation 74.2
|
SECONDARY outcome
Timeframe: 6 minutes pre/postChange in Average knee angle across stance phase measured in degrees
Outcome measures
| Measure |
Therapist Supervised Assistance Training
n=11 Participants
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
|
Therapist Supervised Resistance Training
n=12 Participants
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
|
|---|---|---|
|
Change in Gait Kinetics
|
-1.62 degrees
Standard Deviation 2.05
|
-2.00 degrees
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: baseline and post interventionStep length during walking
Outcome measures
| Measure |
Therapist Supervised Assistance Training
n=11 Participants
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
|
Therapist Supervised Resistance Training
n=13 Participants
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
|
|---|---|---|
|
Change in Step Length
|
0.082 m
Standard Deviation 0.184
|
0.072 m
Standard Deviation 0.142
|
SECONDARY outcome
Timeframe: 20 minutes pre/postChange in Gross motor function measure scale 66, min score = 0, max score = 66, high score is better. Unit of measure = Scores on a scale.
Outcome measures
| Measure |
Therapist Supervised Assistance Training
n=12 Participants
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
|
Therapist Supervised Resistance Training
n=16 Participants
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
|
|---|---|---|
|
Change in Gross Motor Function Measure Scale 66
|
1.43 scores on a scale
Standard Deviation 3.1
|
1.56 scores on a scale
Standard Deviation 2.032
|
SECONDARY outcome
Timeframe: baseline and post interventionHow fast participants prefer to walk quickly (m/s)
Outcome measures
| Measure |
Therapist Supervised Assistance Training
n=12 Participants
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
|
Therapist Supervised Resistance Training
n=14 Participants
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
|
|---|---|---|
|
Change in Fast Walking Speed
|
0.06 m/s
Standard Deviation 0.18
|
0.18 m/s
Standard Deviation 0.21
|
Adverse Events
Therapist Supervised Assistance Training
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Therapist Supervised Resistance Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Therapist Supervised Assistance Training
n=12 participants at risk
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
|
Therapist Supervised Resistance Training
n=16 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
25.0%
3/12 • Number of events 3 • During the protocol, approximately 4 weeks
|
0.00%
0/16 • During the protocol, approximately 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place