Trial Outcomes & Findings for A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy (NCT NCT05865418)
NCT ID: NCT05865418
Last Updated: 2026-08-17
Results Overview
Unrestrained Maximum Walking Speed Test employed a 6-m-long pressure-sensitive mat (ProtoKinetics Zeno™ Walkway Gait Analysis System; ProtoKinetics LLC, Havertown, PA, USA), where participants started two steps before and walked past the mat at their fastest safe speed, with the mat capturing spatiotemporal gait measures (such as speed (m/s), step length (cm), and cadence (steps/min)) to measure their functional mobility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
week 4
Results posted on
2026-08-17
Participant Flow
Participants were recruited through convenience sampling. Recruitment involved advertisements placed on clinical trial websites, flyers posted around the University of Alabama at Birmingham (UAB) campus buildings, referrals from healthcare providers, and word-of-mouth recommendations. Interested individuals reached out to research staff via email or phone and were screened for eligibility through telephone interviews.
A single non-blinded tester used a simple randomization technique via a computer-generated coding to randomly allocate the enrolled participants to different arms in our study before their baseline testing.
Participant milestones
| Measure |
Functionally Loaded High-Intensity Circuit Training (FUNHIT)
This arm performed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. FUNHIT participants wore vests starting at 2.5% of their body weight (week 1), with load increased by 2.5% each week up to 10% by the fourth week. We had 2 participants started and completed this arm.
|
High-Intensity Circuit Training (HIT)
HIT participants completed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. HIT participants completed exercises without added weight.
|
Control
Control participants were instructed to continue their normal daily activities and did not receive any additional training.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Functionally Loaded High-Intensity Circuit Training (FUNHIT)
n=2 Participants
This arm performed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. FUNHIT participants wore vests starting at 2.5% of their body weight (week 1), with load increased by 2.5% each week up to 10% by the fourth week. We had 2 participants started and completed this arm.
|
High-Intensity Circuit Training (HIT)
n=1 Participants
HIT participants completed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. HIT participants completed exercises without added weight.
|
Control
n=2 Participants
Control participants were instructed to continue their normal daily activities and did not receive any additional training.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Unrestrained maximum walking speed
|
125.3155 cm/s
STANDARD_DEVIATION 6.665895626 • n=2 Participants
|
71.397 cm/s
STANDARD_DEVIATION 0 • n=1 Participants
|
213.6925 cm/s
STANDARD_DEVIATION 5.400174488 • n=2 Participants
|
149.8826 cm/s
STANDARD_DEVIATION 62.41810021 • n=5 Participants
|
|
Restrained maximum walking speed
|
66.623 cm/s
STANDARD_DEVIATION 12.2626458 • n=2 Participants
|
41.2 cm/s
STANDARD_DEVIATION 0 • n=1 Participants
|
89.3725 cm/s
STANDARD_DEVIATION 4.128796495 • n=2 Participants
|
70.6382 cm/s
STANDARD_DEVIATION 21.02509641 • n=5 Participants
|
|
Four square step test
|
9.92 second
STANDARD_DEVIATION 1.725340546 • n=2 Participants
|
29.73 second
STANDARD_DEVIATION 0 • n=1 Participants
|
5.895 second
STANDARD_DEVIATION 0.473761543 • n=2 Participants
|
12.272 second
STANDARD_DEVIATION 10.00473738 • n=5 Participants
|
|
Timed Up and Go
|
9.575 Seconds
STANDARD_DEVIATION 0.926309883 • n=2 Participants
|
14.64 Seconds
STANDARD_DEVIATION 0 • n=1 Participants
|
9.17 Seconds
STANDARD_DEVIATION 1.032375901 • n=2 Participants
|
10.426 Seconds
STANDARD_DEVIATION 2.463996753 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 4Unrestrained Maximum Walking Speed Test employed a 6-m-long pressure-sensitive mat (ProtoKinetics Zeno™ Walkway Gait Analysis System; ProtoKinetics LLC, Havertown, PA, USA), where participants started two steps before and walked past the mat at their fastest safe speed, with the mat capturing spatiotemporal gait measures (such as speed (m/s), step length (cm), and cadence (steps/min)) to measure their functional mobility.
Outcome measures
| Measure |
High-Intensity Circuit Training (HIT)
n=1 Participants
HIT participants completed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. HIT participants completed exercises without added weight.
|
Control
n=2 Participants
Control participants were instructed to continue their normal daily activities and did not receive any additional training.
|
Functionally Loaded High-Intensity Circuit Training (FUNHIT)
n=2 Participants
This arm performed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. FUNHIT participants wore vests starting at 2.5% of their body weight (week 1), with load increased by 2.5% each week up to 10% by the fourth week. We had 2 participants started and completed this arm.
|
|---|---|---|---|
|
Unrestrained Walking Speed
|
72.957 cm/s
Standard Deviation 0
|
225.341 cm/s
Standard Deviation 20.3024499
|
138.026 cm/s
Standard Deviation 3.54119076
|
PRIMARY outcome
Timeframe: Week 4This test required participants to start by standing on the mat and then walking at their fastest safe speed and stopping at a marked position on the mat near its endpoint
Outcome measures
| Measure |
High-Intensity Circuit Training (HIT)
n=1 Participants
HIT participants completed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. HIT participants completed exercises without added weight.
|
Control
n=2 Participants
Control participants were instructed to continue their normal daily activities and did not receive any additional training.
|
Functionally Loaded High-Intensity Circuit Training (FUNHIT)
n=2 Participants
This arm performed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. FUNHIT participants wore vests starting at 2.5% of their body weight (week 1), with load increased by 2.5% each week up to 10% by the fourth week. We had 2 participants started and completed this arm.
|
|---|---|---|---|
|
Restrained Maximum Walking Speed
|
47.121 cm/s
Standard Deviation 0
|
92.6655 cm/s
Standard Deviation 13.00581503
|
70.537 cm/s
Standard Deviation 6.580335706
|
SECONDARY outcome
Timeframe: Week 4Measure by time to complete test. A decrease in time completed is expected.
Outcome measures
| Measure |
High-Intensity Circuit Training (HIT)
n=1 Participants
HIT participants completed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. HIT participants completed exercises without added weight.
|
Control
n=2 Participants
Control participants were instructed to continue their normal daily activities and did not receive any additional training.
|
Functionally Loaded High-Intensity Circuit Training (FUNHIT)
n=2 Participants
This arm performed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. FUNHIT participants wore vests starting at 2.5% of their body weight (week 1), with load increased by 2.5% each week up to 10% by the fourth week. We had 2 participants started and completed this arm.
|
|---|---|---|---|
|
Four Square Step Test
|
20.73 seconds
Standard Deviation 0
|
5.95 seconds
Standard Deviation 0.395979797
|
7.64 seconds
Standard Deviation 0.353553391
|
SECONDARY outcome
Timeframe: Week 4The Timed Up and Go Test (TUG) involved participants rising from a standard chair, walking 3 m to a marked cone, turning 180 degrees, and returning to sit, with time recorded in seconds using a stopwatch to evaluate functional mobility
Outcome measures
| Measure |
High-Intensity Circuit Training (HIT)
n=1 Participants
HIT participants completed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. HIT participants completed exercises without added weight.
|
Control
n=2 Participants
Control participants were instructed to continue their normal daily activities and did not receive any additional training.
|
Functionally Loaded High-Intensity Circuit Training (FUNHIT)
n=2 Participants
This arm performed 8 supervised training sessions over 4 weeks (twice weekly). Each session (around 23 minutes) included five functional movements: split squat, chair squat, side-step, heel raise, and countermovement jump. FUNHIT participants wore vests starting at 2.5% of their body weight (week 1), with load increased by 2.5% each week up to 10% by the fourth week. We had 2 participants started and completed this arm.
|
|---|---|---|---|
|
Timed Up and Go
|
12.96 seconds
Standard Deviation 0
|
8.585 seconds
Standard Deviation 0.473761543
|
9.225 seconds
Standard Deviation 0.883883476
|
Adverse Events
Functionally Loaded High-Intensity Circuit Training (FUNHIT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-Intensity Circuit Training (HIT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place