Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02987517 |
| Other study ID # |
2015P000724 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 5, 2016 |
| Last updated |
April 17, 2018 |
| Start date |
January 2016 |
| Est. completion date |
May 31, 2017 |
Study information
| Verified date |
April 2018 |
| Source |
Spaulding Rehabilitation Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will use a comparative effectiveness design of two interventions known to reduce
running impacts. The study will be conducted at the Spaulding National Running Center. A
total of 40 male and female participants, between ages 18-50 years, running 10- 30 miles per
week will be recruited from the local running community. All potential subjects will be
cleared for physical activity using a Physical Activity Readiness Questionnaire (PAR-Q) and
screened via high-speed video to determine their habitual footstrike pattern. Those who are
rearfoot strikers will be included and will then be randomized to either an increased cadence
(CAD) or a forefoot strike (FFS) intervention group. Standardized running shoes will be
provided to both groups for the duration of the study. All participants will attend 2
strength-training instruction sessions with a physical therapist prior to gait-retraining
intervention. They will be instructed to perform the learned exercises daily for 4 weeks to
prepare the body tissues for forces associated with new gait methods. Subjects will then
attend 8 gait-retraining sessions over 2-3 weeks. Sessions will be scheduled as two
sequential days of training followed by a day of rest. The gait retraining protocols will be
conducted on a treadmill. 3D Motion Capture analysis will be conducted at baseline and at 3
points following intervention (1 week, 1 month, and 6 months).
Description:
SUBJECT ENROLLMENT
When potential participants are contacted (or contact investigators), they will be screened
by phone or email to ensure they meet the study inclusion or exclusion criteria. If they do,
details of the study procedures will be explained and they will be given the opportunity to
ask questions and take as much time as required to decide if they would like to participate.
In addition, once consent is obtained, subjects will undergo an initial screening treadmill
run to ensure foot strike and cadence inclusion criteria are met.
Before the study begins, participants will be provided with a written consent form and be
given the opportunity to ask any further questions. Prior to initiation of initial screening,
data collection, or treatment, participants must sign the consent form.
Participants will be randomly assigned via computer to one of two treatment conditions: 1)
increased cadence running gait or 2) forefoot strike running gait.
STUDY PROCEDURES
Subjects will have 13 visits to the Spaulding National Running Center for screening,
interventions, and biomechanical analyses. Each visit is outlined below: Visit 1 (2.5 hours)
determine if subject uses habitual heel strike and cadence less than or equal to 170, color
vision test measure subject's weight, height, leg length, and arch height Baseline
biomechanical analysis on instrumented treadmill Physical therapist-researcher will instruct
strengthening exercises for feet and legs Subjects told to perform exercises daily and keep
journal for 4 weeks
Visit 2 (30 minutes) One week after exercise instruction, subjects meet with a
physical-therapist researcher to review and perform strengthening exercises and voice any
questions or concerns
Visits 3-10 (1 hour each) Gait retraining on a treadmill using auditory feedback (metronome
for cadence or Noraxon system for forefoot strike) and verbal instruction from a physical
therapist.
These visits will be distributed over a 2-3 week time period. Subjects may run 2 days in a
row, but never 3 days in a row.
Visit 11 (1 week after final gait retraining) (2 hours) Measure subject's resting heart rate,
weight, height, leg length, and arch height Biomechanical analysis of running gait on
instrumented treadmill Biomechanical analysis of running gait on instrumented treadmill until
either 85-90 percent of age predicted heart rate is reached or a Borg Rating of Perceived
Exertion score of greater than or equal to 17 is reached.
Subjects instructed in use of REDCap secure web application for journal of running frequency
and distance (in miles), any discomfort or injuries that occur with running over the next 6
months.
Visit 12 (1 month after final gait retraining) (2 hours)
Measure subject's weight, height, leg length, and arch height Biomechanical analysis on
instrumented treadmill Remind subjects to continue to keep journal
Reminder via email or phone call Physical therapist-researcher will contact subjects 1 time
per month over the next 5 months to remind them to continue keeping journal of running
frequency and distance (in miles), and any discomfort or injuries that occur.
Visit 13 (6 months after final gait retraining) (2 hours) Measure subject's weight, height,
leg length, and arch height Biomechanical analysis on instrumented treadmill
The outcomes to be measured may include any combination of the following:
Structural measures: Height, weight, leg length, arch height. Video analysis: Digital video
will only record the waist and below. Motion analysis: recording 3 dimensional movements
using a computerized system with reflective markers attached to the body and high-speed
cameras.
Ground reaction forces: gathered through force sensing platforms embedded in the treadmill
Impact: an accelerometer attached to the body to record the impact experienced by the body
with each footstrike.
Devices to be used The data will be collected using 3D motion capture (Vicon Motion Systems)
in conjunction with 2 force plates (AMTI), which are embedded in the treadmill. Other devices
to be used are foot calipers for arch height, a digital metronome, and an accelerometer with
auditory feedback (Noraxon). These are all minimally invasive procedures that involve
attaching sensors or markers to the skin and recording the output from the sensor.
d) Procedures/interventions All study procedures will take place at the Spaulding National
Running Center in the Instrumented Treadmill Lab and clinic. Biomechanical Analysis
All biomechanical analyses of running gait will take place in the Treadmill Lab using an
instrumented treadmill (AMTI) and a 3D motion analysis system. Four biomechanical analyses
will be conducted over the duration of this investigation. These will occur at baseline, 1
week after the final gait retraining session, 1 month following gait retraining, and 6 months
following gait retraining. Procedures for each analysis are as follows:
Subjects will run for a 3 minute warm up and be allowed to adjust to a speed of their
preference. An investigator will control treadmill speed, but both participant and
investigator can stop the treadmill at anytime via the emergency stop buttons. After warm up,
data collection will occur for 4000 frames (15-20 steps). To minimize or prevent any
laboratory performance effects, subjects will be distracted during data recording. The
distraction technique is based on the Stroop Color and Word Test, and involves subjects
reading aloud words on a screen directly in front of the treadmill. The correctness of the
test is of no interest; rather, it only serves as a distraction technique.
Fatigue run One week after the final gait retraining session, subjects will be asked to run
until they feel fatigued. Fatigue will be defined as either of the following two criteria:
when the subject reaches 85-90 percent of age predicted heart rate max or when they report a
score greater than or equal to 17 on the Borg Rating of Perceived Exertion scale. Once
fatigue is reached, data will be collected for 4000 frames (15-20 steps).
Strengthening exercises During the first visit, a physical-therapist investigator will
instruct subjects in strengthening exercises for the feet and legs. These activities will
prepare musculoskeletal tissues to adapt to new forces they will experience during gait
retraining. Subjects will be instructed to perform the exercises daily for 4 weeks, and will
be given a journal to record their exercise performance. One week after exercise instruction,
subjects will meet with the physical therapist-investigator to review the strengthening
exercises and report any questions or concerns.
Gait Retraining
There will be 8 gait-retraining sessions over a 2-3 week time period. Subjects will be
randomly assigned to either an increased cadence gait or a forefoot strike gait. The gait
retraining protocols will be conducted on a treadmill (Woodway) in the clinic of the
Spaulding National Running Center in the following manner:
Increased cadence (CAD) Protocol: After a 3-minute warm up, subjects' preferred step rate
will be determined during their self-selected moderate intensity run for an additional 3
minutes using a visual count of footstrikes. Subjects will then be asked to increase their
normal cadence by 7.5 percent while maintaining their speed. This will be accomplished by
having subjects match their footstrikes to the beat of an audible digital metronome.
Forefoot strike (FFS) Protocol: Subjects will wear an accelerometer on the right anterior
distal tibial. After a 3-minute warm up run, subjects will continue running for an additional
3 minutes and a baseline rearfoot strike accelerometer value will be recorded. Next, subjects
will be instructed to land gently on the ball of their foot and lower their heels to the
ground. They will be guided with verbal cues and visual inspection from a physical therapist.
A forefoot strike accelerometer value will be recorded. If this value is exceeded, the device
will provide audible feedback when a heel strike is detected signaling the runner to land
with a FFS pattern.
For both groups, run time will be gradually increased from 10-30 minutes over 8 sessions. The
auditory feedback will be provided constantly for the first 4 sessions and then gradually
decreased in a systematic manner for the last four sessions. This feedback schedule has
produced successful outcomes in a number of gait retraining studies.4,5,6 The feedback
schedule for both groups is detailed as follows:
Session 1 - 10 minute treadmill run with metronome auditory feedback 100 percent of the time
Sessions 2,3,4 - Time of run will be gradually increased over sessions 2,3,4 to 12, 15, and
18 minutes respectively. Auditory feedback 100 percent of the time.
Sessions 5,6,7,8 - Time of run will be gradually increased over sessions 5,6,7,8 to 21,24,27,
and 30 minutes respectively. Auditory feedback will be gradually reduced and given only at
the beginning, middle, and end of a run.
This will be 4 minutes for sessions 5; 3 minutes for session 6; 2 minutes for session 7; and
1 minute for session 8.
Participants will be instructed not to run at any other time outside of the gait-retraining
period. After completion of gait retraining, subjects will be encouraged to continue their
new gait pattern as they run independently in the community. They will be instructed to
increase running distance by no greater than 10 percent per week until they reach their
desired running duration or distance. Subjects will be asked to keep journals of running
activity after gait retraining until they return for the final gait analysis. This will be
done via the REDCap (Research Electronic Data Capture) secure web application.
Data to be collected and when the data is to be collected:
Biomechanical outcomes as described above will be collected during each of the 5
biomechanical analyses that participants attend at the Spaulding National Running Center.
Every effort will be made to accommodate participants' schedules for these sessions. Data
collection will occur at the first visit (baseline), 1 week following gait retraining
(approximately 7 to 8 weeks from baseline), 1 month after gait retraining (approximately 11
weeks from baseline), and 6 months after gait retraining (approximately 35 weeks from
baseline).
Journals of daily strengthening exercise performance will be collected at Visit 3 (4 weeks
from baseline). Journals of running frequency and distance and any discomfort or injuries
will be collected throughout the 6 month follow up period using REDCap secure web application
(9 to 35 weeks from baseline).
