Trial Outcomes & Findings for Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin A Injection (NCT NCT06070987)
NCT ID: NCT06070987
Last Updated: 2026-01-20
Results Overview
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. We calculate the relative change by subtracting the initial value from the final value and then dividing the answer by the absolute value of the initial number. (relative change = (post - baseline)/ baseline ×100%) Investigators will use a marker less motion capture system for kinematic analysis, use four high-definition cameras to record 30 fps at a resolution of 4 megapixels. The camera was placed uniformly 5 meters away from the center of the subject at the height of 1 meter, allowing for a maximum number of detections of the entire body. To analyze the kinematics of lower extremity, investigators use Open Pose, a real-time multi-person system, to detect human pose in 2D images Fromm the four high-definition cameras. Investigators will use this test to measure the angle of knee flexion and the step length (cm) of participants.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Relative change from baseline at 5 months
Results posted on
2026-01-20
Participant Flow
40 patients were screened for eligibility between August 1, 2023 and July 31, 2025 at Kaohsiung Chang Gung Memorial Hospital.
30 of 40 participants were randomized. Of those not randomized, 4 declined to participate ,6 did not meeting inclusion criteria.
Participant milestones
| Measure |
RF BoNT-A Injection Plus Robot Therapy Then Robot Therapy Only
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection in first period and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy.
|
Robot Therapy Only Then RF BoNT-A Injection Plus Robot Therapy
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection in second period and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy.
|
|---|---|---|
|
first treatment
STARTED
|
15
|
15
|
|
first treatment
COMPLETED
|
12
|
13
|
|
first treatment
NOT COMPLETED
|
3
|
2
|
|
wash out
STARTED
|
12
|
13
|
|
wash out
COMPLETED
|
10
|
11
|
|
wash out
NOT COMPLETED
|
2
|
2
|
|
second treatment
STARTED
|
10
|
11
|
|
second treatment
COMPLETED
|
8
|
10
|
|
second treatment
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
RF BoNT-A Injection Plus Robot Therapy Then Robot Therapy Only
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection in first period and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy.
|
Robot Therapy Only Then RF BoNT-A Injection Plus Robot Therapy
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection in second period and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy.
|
|---|---|---|
|
first treatment
Withdrawal by Subject
|
1
|
0
|
|
first treatment
Lost to Follow-up
|
1
|
1
|
|
first treatment
Protocol Violation
|
1
|
1
|
|
wash out
did not participate in second treatment
|
2
|
2
|
|
second treatment
Withdrawal by Subject
|
1
|
0
|
|
second treatment
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin A Injection
Baseline characteristics by cohort
| Measure |
RF BoNT-A Injection in First Period and Robot Therapy
n=15 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to none RF BoNT-A injection, and received second round of robot therapy.
|
RF BoNT-A Injection in Second Period and Robot Therapy
n=15 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs. After a 3-month washout period crossover to RF BoNT-A injection, and received second round of robot therapy.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
48.13 years
STANDARD_DEVIATION 10.76 • n=37 Participants
|
53.67 years
STANDARD_DEVIATION 9.33 • n=44 Participants
|
50.9 years
STANDARD_DEVIATION 10.29 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=37 Participants
|
9 Participants
n=44 Participants
|
17 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=37 Participants
|
6 Participants
n=44 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=37 Participants
|
15 Participants
n=44 Participants
|
30 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Taiwan
|
15 participants
n=37 Participants
|
15 participants
n=44 Participants
|
30 participants
n=40 Participants
|
|
stroke survival period
|
40.26 months
STANDARD_DEVIATION 32.54 • n=37 Participants
|
36.21 months
STANDARD_DEVIATION 36.51 • n=44 Participants
|
38.24 months
STANDARD_DEVIATION 34.04 • n=40 Participants
|
|
Affected Side
left
|
5 Participants
n=37 Participants
|
8 Participants
n=44 Participants
|
13 Participants
n=40 Participants
|
|
Affected Side
right
|
10 Participants
n=37 Participants
|
7 Participants
n=44 Participants
|
17 Participants
n=40 Participants
|
|
Botulinum toxin A dosage
Lower extremity
|
311.56 units
STANDARD_DEVIATION 85.63 • n=37 Participants
|
300.71 units
STANDARD_DEVIATION 46.65 • n=44 Participants
|
306.5 units
STANDARD_DEVIATION 69.27 • n=40 Participants
|
|
Botulinum toxin A dosage
Total
|
506.25 units
STANDARD_DEVIATION 176.89 • n=37 Participants
|
528.57 units
STANDARD_DEVIATION 120.44 • n=44 Participants
|
516.67 units
STANDARD_DEVIATION 151.05 • n=40 Participants
|
|
Functional Ambulation Category
|
4.56 scores on a scale
STANDARD_DEVIATION 0.51 • n=37 Participants
|
4.64 scores on a scale
STANDARD_DEVIATION 0.5 • n=44 Participants
|
4.6 scores on a scale
STANDARD_DEVIATION 0.51 • n=40 Participants
|
|
Use of Ankle-Foot Orthosis
Yes
|
7 Participants
n=37 Participants
|
6 Participants
n=44 Participants
|
13 Participants
n=40 Participants
|
|
Use of Ankle-Foot Orthosis
No
|
8 Participants
n=37 Participants
|
9 Participants
n=44 Participants
|
17 Participants
n=40 Participants
|
|
Use of Assisted devices
One cane
|
3 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
5 Participants
n=40 Participants
|
|
Use of Assisted devices
Quadricane
|
4 Participants
n=37 Participants
|
4 Participants
n=44 Participants
|
8 Participants
n=40 Participants
|
|
Use of Assisted devices
none
|
8 Participants
n=37 Participants
|
9 Participants
n=44 Participants
|
17 Participants
n=40 Participants
|
|
Mini-Mental State Examination
|
24.5 scores on a scale
STANDARD_DEVIATION 5.72 • n=37 Participants
|
26.73 scores on a scale
STANDARD_DEVIATION 2.94 • n=44 Participants
|
25.66 scores on a scale
STANDARD_DEVIATION 4.56 • n=40 Participants
|
|
Education
|
15.33 years
STANDARD_DEVIATION 5.78 • n=37 Participants
|
17.47 years
STANDARD_DEVIATION 5.73 • n=44 Participants
|
16.4 years
STANDARD_DEVIATION 5.76 • n=40 Participants
|
PRIMARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. We calculate the relative change by subtracting the initial value from the final value and then dividing the answer by the absolute value of the initial number. (relative change = (post - baseline)/ baseline ×100%) Investigators will use a marker less motion capture system for kinematic analysis, use four high-definition cameras to record 30 fps at a resolution of 4 megapixels. The camera was placed uniformly 5 meters away from the center of the subject at the height of 1 meter, allowing for a maximum number of detections of the entire body. To analyze the kinematics of lower extremity, investigators use Open Pose, a real-time multi-person system, to detect human pose in 2D images Fromm the four high-definition cameras. Investigators will use this test to measure the angle of knee flexion and the step length (cm) of participants.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Hip flexion / extension angle (affected side)
|
9 percentage (relative change)
Standard Deviation 14
|
-2 percentage (relative change)
Standard Deviation 22
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Hip flexion / extension angle (unaffected side)
|
9 percentage (relative change)
Standard Deviation 26
|
2 percentage (relative change)
Standard Deviation 15
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Knee flexion / extension angle (affected side)
|
38 percentage (relative change)
Standard Deviation 53
|
-3 percentage (relative change)
Standard Deviation 33
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Knee flexion / extension angle (unaffected side)
|
10 percentage (relative change)
Standard Deviation 14
|
0.4 percentage (relative change)
Standard Deviation 12
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Ankle dorsiflexion / plantar flexion angle (affected side)
|
10 percentage (relative change)
Standard Deviation 31
|
6 percentage (relative change)
Standard Deviation 43
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Ankle dorsiflexion / plantar flexion angle (unaffected side)
|
7 percentage (relative change)
Standard Deviation 31
|
-1 percentage (relative change)
Standard Deviation 16
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Maximum Mean Speed
|
13 percentage (relative change)
Standard Deviation 12
|
15 percentage (relative change)
Standard Deviation 40
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Variability of speed on steady state (rms)
|
3 percentage (relative change)
Standard Deviation 27
|
14 percentage (relative change)
Standard Deviation 37
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Variability of speed on Acceleration and Decceleration state (rms)
|
8 percentage (relative change)
Standard Deviation 44
|
16 percentage (relative change)
Standard Deviation 48
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Variability of speed on All state (rms)
|
2 percentage (relative change)
Standard Deviation 29
|
15 percentage (relative change)
Standard Deviation 38
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Center of Mass of Lateral direction for AUC
|
-2 percentage (relative change)
Standard Deviation 23
|
9 percentage (relative change)
Standard Deviation 24
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Center of Mass of vertical direction for distance swings
|
38 percentage (relative change)
Standard Deviation 133
|
59 percentage (relative change)
Standard Deviation 121
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Stride length (affected side)
|
14 percentage (relative change)
Standard Deviation 16
|
14 percentage (relative change)
Standard Deviation 27
|
|
Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)
Stride length (unaffected side)
|
11 percentage (relative change)
Standard Deviation 11
|
18 percentage (relative change)
Standard Deviation 28
|
PRIMARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. A cyclogram is used to represent the functional relationship between joints during a full gait cycle, and is constructed by plotting two angles on the X-Y plane (the alteration of the hip and knee joint). It has several types of clinically relevant parameters, such as ROM of the joints, the cyclogram perimeter, the cyclogram area. And we can also compare the different between affected and unaffected side by looking at the cyclogram orientation, the trend symmetry, and the square root of the sum of squared deviation (A value of 0 indicates greater symmetry and coordination)
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
hip range of motion in gait cycle (affected side)
|
22 percentage (relative change)
Standard Deviation 46
|
-5 percentage (relative change)
Standard Deviation 24
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
hip range of motion in gait cycle (unaffected side)
|
9 percentage (relative change)
Standard Deviation 13
|
2 percentage (relative change)
Standard Deviation 18
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
the square root of the sum of squared deviation
|
-16 percentage (relative change)
Standard Deviation 26
|
16 percentage (relative change)
Standard Deviation 42
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Peak knee flexion angle (affected side)
|
11 percentage (relative change)
Standard Deviation 25
|
16 percentage (relative change)
Standard Deviation 36
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Peak knee flexion angle (unaffected side)
|
6 percentage (relative change)
Standard Deviation 9
|
5 percentage (relative change)
Standard Deviation 10
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Cyclogram orientation of knee joints
|
-21 percentage (relative change)
Standard Deviation 40
|
128 percentage (relative change)
Standard Deviation 431
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Cyclogram orientation of hip joints
|
-12 percentage (relative change)
Standard Deviation 54
|
28 percentage (relative change)
Standard Deviation 93
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Trend symmetry of knee joints
|
-7 percentage (relative change)
Standard Deviation 60
|
42 percentage (relative change)
Standard Deviation 81
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Trend symmetry of hip joints
|
34 percentage (relative change)
Standard Deviation 121
|
88 percentage (relative change)
Standard Deviation 270
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Cyclogram perimeters (affected side)
|
25 percentage (relative change)
Standard Deviation 48
|
0.5 percentage (relative change)
Standard Deviation 28
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Cyclogram perimeters (unaffected side)
|
6 percentage (relative change)
Standard Deviation 11
|
5 percentage (relative change)
Standard Deviation 17
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Cyclogram area (affected side)
|
92 percentage (relative change)
Standard Deviation 177
|
8 percentage (relative change)
Standard Deviation 68
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
Cyclogram area (unaffected side)
|
24 percentage (relative change)
Standard Deviation 25
|
9 percentage (relative change)
Standard Deviation 34
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
knee range of motion in gait cycle (affected side)
|
24 percentage (relative change)
Standard Deviation 40
|
2 percentage (relative change)
Standard Deviation 32
|
|
Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation
knee range of motion in gait cycle (unaffected side)
|
9 percentage (relative change)
Standard Deviation 14
|
2 percentage (relative change)
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The mEFAP is a clinical test that measures the time to ambulate through five common environmental terrains with or without an assistive device .It has been demonstrated to have a high inter-rater and test-retest reliability as a measure of gait capacity and functional ambulation in the post stroke patient population. The mEFAP comprises five timed tasks: (1) a 5-m walk on a hard floor; (2) a 5-m walk on a carpeted surface; (3) to rise from a chair, a 3-m walk, and return to a seated position (the timed "up-and-go" test); (4) a standardized obstacle course; and (5) to ascent and descent five stairs. The five timed sub scores will be adjusted by a multiplier for any necessary assistive device and then add together to derive a composite score.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Modified Emory Functional Ambulation Profile(mEFAP)
5-m walk on a hard floor
|
-15 percentage (relative change)
Standard Deviation 22
|
-7 percentage (relative change)
Standard Deviation 31
|
|
Modified Emory Functional Ambulation Profile(mEFAP)
5-m walk on a carpeted surface
|
-15 percentage (relative change)
Standard Deviation 19
|
-13 percentage (relative change)
Standard Deviation 25
|
|
Modified Emory Functional Ambulation Profile(mEFAP)
timed "up-and-go" test
|
-14 percentage (relative change)
Standard Deviation 16
|
-6 percentage (relative change)
Standard Deviation 30
|
|
Modified Emory Functional Ambulation Profile(mEFAP)
standardized obstacle course
|
-10 percentage (relative change)
Standard Deviation 24
|
-10 percentage (relative change)
Standard Deviation 28
|
|
Modified Emory Functional Ambulation Profile(mEFAP)
ascent and descent five stairs
|
-12 percentage (relative change)
Standard Deviation 23
|
-5 percentage (relative change)
Standard Deviation 29
|
|
Modified Emory Functional Ambulation Profile(mEFAP)
total time to complete five tasks
|
-13 percentage (relative change)
Standard Deviation 16
|
-9 percentage (relative change)
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. Spasticity of skeletal muscle in lower extremity was evaluated by using the MAS scale. It uses a 8-point scale (0, 1, 1+,2, 2+, 3, 3+, 4) to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity. Investigators assessed the MAS of knee flexor/ extensor, ankle dorsiflexor/planta flexor in sitting position. The maximum of MAS scale is 4, and the minimum is 0. The higher scores mean a worse outcome.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Modified Ashworth Scale
knee flexor
|
-5 percentage (relative change)
Standard Deviation 22
|
-5 percentage (relative change)
Standard Deviation 22
|
|
Modified Ashworth Scale
knee extensor
|
-12 percentage (relative change)
Standard Deviation 35
|
-11 percentage (relative change)
Standard Deviation 31
|
|
Modified Ashworth Scale
ankle dorsiflexor
|
0 percentage (relative change)
Standard Deviation 0
|
0 percentage (relative change)
Standard Deviation 0
|
|
Modified Ashworth Scale
ankle plantar flexor
|
-2 percentage (relative change)
Standard Deviation 42
|
-11 percentage (relative change)
Standard Deviation 32
|
SECONDARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The MRC scale is a reliable measurement which ranges from 0 (no contraction) to 5 (normal power). Total scale combines all range and computes average scores, the higher scores mean a better outcome. The MRC scale will be used to examine the muscle strength of the affected hip flexion, knee flexion, knee extension, and ankle dorsiflexion. Select an appropriate testing posture based on the client's abilities.(If the client cannot be assessed in a standing position, use a sitting position instead, but it would result in a lower score.)
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Medical Research Council Scale
knee extension
|
-1 percentage (relative change)
Standard Deviation 15
|
6 percentage (relative change)
Standard Deviation 20
|
|
Medical Research Council Scale
hip flexion
|
4 percentage (relative change)
Standard Deviation 13
|
5 percentage (relative change)
Standard Deviation 22
|
|
Medical Research Council Scale
hip extension
|
16 percentage (relative change)
Standard Deviation 29
|
-4 percentage (relative change)
Standard Deviation 20
|
|
Medical Research Council Scale
knee flexion
|
-1 percentage (relative change)
Standard Deviation 23
|
0.3 percentage (relative change)
Standard Deviation 15
|
|
Medical Research Council Scale
ankle dorsiflexion
|
-14 percentage (relative change)
Standard Deviation 40
|
-5 percentage (relative change)
Standard Deviation 61
|
|
Medical Research Council Scale
ankle plantar flexion
|
-1 percentage (relative change)
Standard Deviation 42
|
5 percentage (relative change)
Standard Deviation 33
|
SECONDARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The pendulum test was performed to assess spasticity of the knee extensors. During each trial, inertial measurement unit (IMU) data were recorded, including angular velocity from the gyroscope, linear acceleration from the accelerometer, and magnetic field from the magnetometer. Pendular parameters (first swing excursion and relaxation index) were derived from knee angle trajectories measured using an electrogoniometer. The proximal and distal sensor endblocks were secured 15 cm above and 15 cm below the lateral femoral epicondyle, respectively. The two sensor were used to obtain one integrated knee-joint angle signal based on the relative motion between segments, rather than two separate outputs. Previous study showed the pendular parameters can provide additional ambulatory information, as complementary to the MAS .
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Pendulum Test
gyrometer degree
|
7 percentage (relative change)
Standard Deviation 20
|
15 percentage (relative change)
Standard Deviation 47
|
|
Pendulum Test
accelerometer degree
|
1 percentage (relative change)
Standard Deviation 8
|
-2 percentage (relative change)
Standard Deviation 5
|
|
Pendulum Test
magnet degree
|
-7 percentage (relative change)
Standard Deviation 22
|
10 percentage (relative change)
Standard Deviation 28
|
SECONDARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The BBS is a 14-item scale, which is widely used to assess balance disorders in people with stroke, each item is scored from 0 to 4 points. The reliability and validity of the BBS are well established. Investigators used BBS for balance function assessment. The higher scores mean a better outcome.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Berg Balance Scale
|
2 percentage (relative change)
Standard Deviation 6
|
3 percentage (relative change)
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The 6MWT is commonly used to assess patients' cardiovascular or respiratory problems and is regarded as a submaximal test of aerobic capacity. Investigators will use 6MWT to assess walking endurance. It is now commonly used in stroke patients and is highly reliable in this group. The maximum distance covered on a 20-m walkway in 6 mins is recorded.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Six-Minute Walking Test
|
11 percentage (relative change)
Standard Deviation 20
|
14 percentage (relative change)
Standard Deviation 23
|
SECONDARY outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. Isometric strength was measured using the Biodex System 3a. Investigators use to test consisting of three knee flexion/extension isometric contractions at 30°, 45°, 90° knee flexion, and record data of isometric peak torque (Nm/kg).Five-second maximal voluntary isometric contraction (MVIC) trials were performed ten times. A rest of 15s was given between contractions for each trial, and the interval between two angles was approximately 2 min. Isometric peak torque (Nm/kg) was calculated as the highest value from the filtered torque data during each MVIC, which was normalized by the body mass. The isometric peak torque (Nm) was obtained from the Biodex System 3 software for both flexion and extension.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Isometric Strength
90° knee flexion
|
5 percentage (relative change)
Standard Deviation 27
|
2 percentage (relative change)
Standard Deviation 25
|
|
Isometric Strength
90° knee extension
|
5 percentage (relative change)
Standard Deviation 75
|
28 percentage (relative change)
Standard Deviation 116
|
|
Isometric Strength
45° knee flexion
|
3 percentage (relative change)
Standard Deviation 27
|
-10 percentage (relative change)
Standard Deviation 30
|
|
Isometric Strength
45° knee extension
|
7 percentage (relative change)
Standard Deviation 21
|
8 percentage (relative change)
Standard Deviation 34
|
|
Isometric Strength
30° knee flexion
|
-16 percentage (relative change)
Standard Deviation 53
|
-11 percentage (relative change)
Standard Deviation 48
|
|
Isometric Strength
30° knee extension
|
-2 percentage (relative change)
Standard Deviation 27
|
14 percentage (relative change)
Standard Deviation 32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The Nottingham Extended Activities of Daily Living Index (Eadl) is made up of 22 items divided into 4 sections, each item is scored from 0 to 3 points. Investigators only use Eadl index mobility subdomain to assess the community participation level of participants, which includes 6 items and ranges from 0 to 12, with higher scores indicating better performance.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Nottingham Extended Activities of Daily Living Index
|
19 percentage (relative change)
Standard Deviation 35
|
9 percentage (relative change)
Standard Deviation 33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Relative change from baseline at 5 monthsPopulation: We included the data of participants who received a botulinum toxin injection to rectus femoris into one group for analysis, and those who did not into the other; both groups underwent robot therapy. As the group titles indicates.
Results are expressed as relative change from baseline, which is a unitless number or expressed as a percentage. The Activities-specific Balance confidence (ABS) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. ABC scale consists of a wide continuum of less and more challenging daily activities. The ABS scale has 16 items, representing daily activities. Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%, how confident they are in performing each activity. The average score obtained is an indication on balance confidence.
Outcome measures
| Measure |
RF BoNT-A Injection and Robot Therapy
n=21 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected in the affected rectus femoris, then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
None RF BoNT-A Injection and Robot Therapy
n=20 Participants
Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 100 units. The dose range of each target muscle is as below:100 units in rectus femoris.
RF BoNT-A injection and robot therapy: Wearable overground exoskeleton lower extremity robot system will be used in this study. The robot lower extremity system consisted with bilateral motors for assisting left and right knees, a pelvis belt and chariot system for suspending the device, and thigh and shank cuffs for attaching the exoskeleton "links" to the user. Patients will wear receive exoskeleton lower extremity robot after BoNT-A injected (do not inject BoNT-A in the affected rectus femoris), then start to do the functional ambulation training to do 1) walking over ground 2) walking with turning, 3) get in and out of chair, 4) crouching and rising, and 5) going up and down stairs.
|
|---|---|---|
|
Activities-specific Balance Confidence
|
17 percentage (relative change)
Standard Deviation 36
|
-5 percentage (relative change)
Standard Deviation 30
|
Adverse Events
RF BoNT-A Injection and Robot Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
None RF BoNT-A Injection and Robot Therapy
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
Jen-Wen Hung, MD
Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Phone: +886975056689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place