Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05006248
Status:
SUSPENDED
Last Update Posted:
2023-10-06
First Post:
2021-05-24
Brief Title:
Robotic Interventions for Spasticity Treatment
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Robotic Interventions for Spasticity Treatment
Status:
SUSPENDED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Research team and PI reviewing if study design actually captures results to address primary and secondary outcomes
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researchers have developed games controlled by electromyographic EMG and inertial measurement unit IMU activity recorded by a sensor These will provide biofeedback to participants post-stroke about the activity of their paretic muscles The researchers anticipate that providing visual biofeedback will allow subjects to observe the level of co-activation in an agonist-antagonist muscle pair and therefore initiate interventions to reduce their level of co-activation Similarly the researchers will provide additional haptic feedback using an assistive robot at the ankle joint ie M1 and compare the results with the pure visual feedback condition At the end the main objective is to compare 1 conventional robotic continuous passive movement CPM training to 2 training with visual biofeedback and 3 training with both visual and haptic biofeedback
Detailed Description:
Post-stroke patients will be recruited when they are referred to Shirley Ryan AbilityLabs stroke rehabilitation outpatient clinics at Shirley Ryan Ability Labs flagship hospital or satellite SRAlab locations eg Arlington Heights Wheeling Glenview Homewood Northbrook or Burr Ridge or participate in SRALab inpatient rehabilitation The researchers will also recruit from local physicians or from the Clinical Neuroscience Research Registry CNRR Furthermore participant interest and eligibility may also be confirmed from the patient medical record If eligible and interested they will be consented and enrolled and the location of research visits will be based on participant preference at SRAlabs flagship hospital 355 E Erie St Chicago 60611 or at SRAlab Burr Ridge 7600 County Line Road Burr Ridge 60527 Eligible participants will then be randomized using a pre-generated sequence of block randomization numbers to receive either 1 conventional robotic CPM training 2 training with visual biofeedback games or 3 training with visual game and haptic robotic assistance biofeedback Participants will complete a 60 min session to perform 30 minutes of their assigned type of training The goal of this study is to compare the efficacy of the three different rehabilitation training conditions
For each condition 3 sessions per week for a total of 4 weeks will be completed in addition to the daily PT sessions Each training session will be 60 min long and include experimental setup vitals monitoring ie blood pressure heart rate oxygen saturation level and training time The maximum training time for each session will be 30 minutes For healthy participants they will use their dominant foot for all training sessions designated by asking the healthy participant the question which leg do you use to kick a ball For clinical participants they will use their affectedweaker foot for all training sessions
Full clinical assessments will be performed before T0 mid T3 and after T6 training sessions as well as 1 month after finishing all training sessions and 3 months after finishing all training sessions Note that additional 180 min will be allotted before or after the 60 min training session to perform all clinical assessments Flexionextension range of motion ROM Maximal Volitional Electromyographic Activity MVEA Maximum Voluntary Contraction Torque MVCT Modified Ashworth Scale MAS 10-Meter Walk Test 10MWT 6-Minute Walk Test 6MWT Berg Balance Scale BBS Functional Gait Assessment FGA
After the final training session at T6 patients will complete a subjective experience survey Game Experience Stroke Specific Quality of Life SSQoL Short Form 36
CONDITION 1 - CONTINUOUS PASSIVE MOVEMENT CPM TRAINING At the beginning of the session the participants vitals ie blood pressure heart rate oxygen saturation level will be measured Participants will then be seated and secured to the chair with a gait belt and the research personnel will assist with the placement of their limb into the M1 device Velcro straps will be adjusted to prevent movement between the M1 device and the participants foot The shank Velcro straps will also be adjusted to provide support to the knee Three sensors will then be placed either on the tibialis anterior TA or extensor halluces longus EHL vastus lateralis VL and biceps femoris longus BF and soleus S or gastrocnemius GAS muscles on the designated limb after cleaning the skin with alcohol prep pads by a researcher Then the ROM of the ankle joint MVEA and MVCT of the ankle will be measured The participant will then be asked to perform up to 30 min of ankle CPM training The trajectory ROM and rate of oscillations provided during the CPM training will vary according to the participants functional capacity The total session time will be 60 min including the vital measurements experimental setup and CPM training
CONDITION 2 - VISUAL FEEDBACK At the beginning of the session the vitals will be measured Participants will then be seated and secured to the chair with a gait belt and the research personnel will assist with the placement of their limb into the M1 device Velcro straps will be adjusted to prevent movement between the M1 device and the participants foot Shank Velcro straps will also be adjusted to provide support to the knee Three sensors will then be placed either on the tibialis anterior TA or extensor halluces longus EHL vastus lateralis VL and biceps femoris longus BF and soleus S or gastrocnemius GAS muscles on the designated limb after cleaning the skin with alcohol prep pads by a researcher Then the ROM of the ankle joint MVEA and MVCT of the ankle will be measured Based on the ROM of the ankle the movement of the game avatar will be adjusted calibrated so that the ROM of the participant corresponds to the maximum movement required by the avatar to play the game Participants will perform 30 min of training with visual biofeedback games Participants will be observed while playing the games to note any software challenges they may encountered while playing
CONDITION 3 - HAPTIC VISUAL FEEDBACK At the beginning of the session the vitals will be measured Participants will then be seated and secured to the chair with a gait belt and the research personnel will assist with the placement of their limb into the M1 device Velcro straps will be adjusted to prevent movement between the M1 device and the participants foot Shank Velcro straps will also be adjusted to provide support to the knee Three sensors will then be placed either on the tibialis anterior TA or extensor halluces longus EHL vastus lateralis VL and biceps femoris longus BF and soleus S or gastrocnemius GAS muscles on the designated limb after cleaning the skin with alcohol prep pads by a researcher Then the ROM of the ankle joint MVEA and MVCT of the ankle will be measured Based on the ROM of the ankle the movement of the game avatar and assistance provided by the M1 device will be adjusted calibrated Participants will perform up to 30 min of training with visual biofeedback games and haptic biofeedback The assistive torque that is provided by the M1 robot with respect to the EMG signals will be adjusted according to the participant Participants will be observed while playing the games to note any software or hardware challenges they may encountered while playing
For each condition 3 sessions per week for a total of 4 weeks will be completed in addition to the daily PT sessions Each training session will be 60 min long and include experimental setup vitals monitoring ie blood pressure heart rate oxygen saturation level and training time The maximum training time for each session will be 30 minutes For healthy participants they will use their dominant foot for all training sessions designated by asking the healthy participant the question which leg do you use to kick a ball For clinical participants they will use their affectedweaker foot for all training sessions
Full clinical assessments will be performed before T0 mid T3 and after T6 training sessions as well as 1 month after finishing all training sessions and 3 months after finishing all training sessions Note that additional 180 min will be allotted before or after the 60 min training session to perform all clinical assessments Flexionextension range of motion ROM Maximal Volitional Electromyographic Activity MVEA Maximum Voluntary Contraction Torque MVCT Modified Ashworth Scale MAS 10-Meter Walk Test 10MWT 6-Minute Walk Test 6MWT Berg Balance Scale BBS Functional Gait Assessment FGA
After the final training session at T6 patients will complete a subjective experience survey Game Experience Stroke Specific Quality of Life SSQoL Short Form 36
CONDITION 1 - CONTINUOUS PASSIVE MOVEMENT CPM TRAINING At the beginning of the session the participants vitals ie blood pressure heart rate oxygen saturation level will be measured Participants will then be seated and secured to the chair with a gait belt and the research personnel will assist with the placement of their limb into the M1 device Velcro straps will be adjusted to prevent movement between the M1 device and the participants foot The shank Velcro straps will also be adjusted to provide support to the knee Three sensors will then be placed either on the tibialis anterior TA or extensor halluces longus EHL vastus lateralis VL and biceps femoris longus BF and soleus S or gastrocnemius GAS muscles on the designated limb after cleaning the skin with alcohol prep pads by a researcher Then the ROM of the ankle joint MVEA and MVCT of the ankle will be measured The participant will then be asked to perform up to 30 min of ankle CPM training The trajectory ROM and rate of oscillations provided during the CPM training will vary according to the participants functional capacity The total session time will be 60 min including the vital measurements experimental setup and CPM training
CONDITION 2 - VISUAL FEEDBACK At the beginning of the session the vitals will be measured Participants will then be seated and secured to the chair with a gait belt and the research personnel will assist with the placement of their limb into the M1 device Velcro straps will be adjusted to prevent movement between the M1 device and the participants foot Shank Velcro straps will also be adjusted to provide support to the knee Three sensors will then be placed either on the tibialis anterior TA or extensor halluces longus EHL vastus lateralis VL and biceps femoris longus BF and soleus S or gastrocnemius GAS muscles on the designated limb after cleaning the skin with alcohol prep pads by a researcher Then the ROM of the ankle joint MVEA and MVCT of the ankle will be measured Based on the ROM of the ankle the movement of the game avatar will be adjusted calibrated so that the ROM of the participant corresponds to the maximum movement required by the avatar to play the game Participants will perform 30 min of training with visual biofeedback games Participants will be observed while playing the games to note any software challenges they may encountered while playing
CONDITION 3 - HAPTIC VISUAL FEEDBACK At the beginning of the session the vitals will be measured Participants will then be seated and secured to the chair with a gait belt and the research personnel will assist with the placement of their limb into the M1 device Velcro straps will be adjusted to prevent movement between the M1 device and the participants foot Shank Velcro straps will also be adjusted to provide support to the knee Three sensors will then be placed either on the tibialis anterior TA or extensor halluces longus EHL vastus lateralis VL and biceps femoris longus BF and soleus S or gastrocnemius GAS muscles on the designated limb after cleaning the skin with alcohol prep pads by a researcher Then the ROM of the ankle joint MVEA and MVCT of the ankle will be measured Based on the ROM of the ankle the movement of the game avatar and assistance provided by the M1 device will be adjusted calibrated Participants will perform up to 30 min of training with visual biofeedback games and haptic biofeedback The assistive torque that is provided by the M1 robot with respect to the EMG signals will be adjusted according to the participant Participants will be observed while playing the games to note any software or hardware challenges they may encountered while playing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None