Trial Outcomes & Findings for Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury (NCT NCT00900666)
NCT ID: NCT00900666
Last Updated: 2013-06-24
Results Overview
Measured via computerized gait analysis, the average of peak knee flexion during swing phase.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
baseline, 1-month and 4-month post-injection
Results posted on
2013-06-24
Participant Flow
Recruiting began in January of 2008 and concluded June 1, 2011. Recruiting sites included:inpatient and outpatient settings of a rehabiliation hospital, local support groups, assisted living and retirement homes. Target of N=60 (30 in each arm) was not met.
Strict inclusion criteria (e.g., walking velocity, rectus femoris spasticity, and target kinematic aspects of peak knee flexion in swing) eliminated many potential participants. 72 participants screened by phone, 30 declined/disqualified, 42 underwent clinical and gait analysis baseline screening, 23 disqualified. A total of 19 were enrolled
Participant milestones
| Measure |
Botulinum Toxin Injection to Rectus Femoris
botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
|
Saline Injection to Rectus Femoris
placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Treat Stiff Knee Gait Following Acquired Brain Injury
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Injection to Rectus Femoris
n=10 Participants
botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
|
Saline Injection to Rectus Femoris
n=9 Participants
placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
48 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
48.9 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 1-month and 4-month post-injectionMeasured via computerized gait analysis, the average of peak knee flexion during swing phase.
Outcome measures
| Measure |
Botulinum Toxin Injection to Rectus Femoris
n=10 Participants
botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
|
Saline Injection to Rectus Femoris
n=9 Participants
placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
|
|---|---|---|
|
Mean Peak Knee Flexion During Swing Phase of Gait
Peak knee flexion, 1-month post-injection
|
31.6 degrees
Standard Deviation 11.8
|
30.8 degrees
Standard Deviation 14.3
|
|
Mean Peak Knee Flexion During Swing Phase of Gait
Peak knee flexion, 4-month post-injection
|
32.8 degrees
Standard Deviation 11.0
|
28.5 degrees
Standard Deviation 14.5
|
|
Mean Peak Knee Flexion During Swing Phase of Gait
Peak knee flexion, Baseline
|
29.2 degrees
Standard Deviation 11.7
|
29.1 degrees
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: baseline, 1-mo and 4-mo post-injectionPopulation: intention to treat
Average walking speed as calculated during a 6-min walk
Outcome measures
| Measure |
Botulinum Toxin Injection to Rectus Femoris
n=10 Participants
botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
|
Saline Injection to Rectus Femoris
n=9 Participants
placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
|
|---|---|---|
|
Gait Function (Based on 6-Minute Walk)
6min walk test, average speed, baseline
|
.72 meters/sec
Standard Deviation .18
|
.65 meters/sec
Standard Deviation .27
|
|
Gait Function (Based on 6-Minute Walk)
6min walk test, average speed, 1M post-inj
|
.69 meters/sec
Standard Deviation .21
|
.70 meters/sec
Standard Deviation .31
|
|
Gait Function (Based on 6-Minute Walk)
6min walk test, average speed, 4M post-inj
|
.69 meters/sec
Standard Deviation .19
|
.71 meters/sec
Standard Deviation .26
|
Adverse Events
Botulinum Toxin Injection to Rectus Femoris
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Injection to Rectus Femoris
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
Krisanne B. Chapin, PhD
Mary Free Bed Rehabilitation Hospital
Phone: 616-493-9831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place