Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498429
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2020-07-28
Brief Title:
Effect of Integrated Cueing on Functional Transfers in Chronic Stroke Survivors
Sponsor:
Loma Linda University
Organization:
Loma Linda University
Study Overview
Official Title:
Effect of Integrated Manual and Verbal Cueing on Functional Transfers in Chronic Stroke Survivors A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EOIC
Brief Summary:
Physical therapists frequently use manual cueing as a tool to improve movement quality in persons recovering from stroke but evidence to support its effectiveness is lacking
The purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach used by physical therapists during sit to stand training on the midline alignment muscle activation and quality of movement in chronic stroke survivors with hemiplegia
The purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach used by physical therapists during sit to stand training on the midline alignment muscle activation and quality of movement in chronic stroke survivors with hemiplegia
Detailed Description:
Over the last few decades the profession of physical therapy has heavily relied on manual facilitation to improve motor control and functional movement in persons recovering from stroke or other neurological impairments In the 1950s Berta Bobath created Neuro-Developmental Treatment NDT a systematic problem-solving approach that is one of the most widely used methodologies in neurorehabilitation NDT relies heavily on verbal and tactile facilitation as an integrated approach to improve motor control in persons with hemiplegia However current systematic reviews have stated that adequate evidence for the effectiveness of neuro facilitation is lacking In the current climate of evidence-based practice neurologic physical therapists no longer blindly accept the use of traditional interventions and instead rely on peer-reviewed research studies to support their clinical decision-making
However the question remains for many physical therapists are skilled manual cues really an essential ingredient in the post-stroke recipe Most practicing neurologic physical therapists would claim that their hands are their most valuable tools and that the way in which they use their hands has a direct effect on movement patterns and functional outcomes with their patients Ploughman and colleagues reported that manual tactile cues during gait had robust but short-lived impacts on cadence and time in double support during gait but their findings are merely a step in the right direction An integrative approach of both manual and verbal cues have anecdotally shown to be effective to treat impairments from stroke but there continues to be a dearth of evidence to accurately support the pervasive use of manual facilitation by physical therapists While support for manual tactile cueing is merely beginning to move in the right direction strong evidence exists that task specific training can improve functional outcomes by focusing training on desired movements and activities But what part does manual cueing truly play in task specific training Sit to stand is an essential activity of daily living that is often impaired in stroke survivors and is commonly trained by physical therapists from both task specific training and NDT schools of thought Physical therapists need further clarification as to which methods are most effective for facilitating maximum learning and recovery during this functional task in order to craft an ideal recipe
Training correct movement patterns in order to improve functional independence is important at every stage of recovery after stroke Kerr et al suggested that successful sit to stand movements require proper training of the critical timing of events as well as improving synergistic activation of the appropriate lower limb musculature Ultimately asymmetry can lead to a conditioned suppression of available movement termed learned non-use Continual reinforcement of poor movement strategies thus leads to passive suppression of maximally efficient normal movements unless the stroke survivor is actively retrained to unlock masked abilities over time Teasell and colleagues confirmed the importance of skilled rehabilitation throughout all phases of recovery including the chronic stroke phase though this important population regularly experiences fewer opportunities to participate in therapy as time progresses Measurable gains may be slower at this stage but the ability to perform essential mobility tasks remains just as important to the individual
Thus the purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach during sit to stand training on the midline alignment muscle activation and quality of movement in chronic stroke survivors with hemiplegia By determining the essential ingredients that lead to an ideal recipe for success physical therapists may have more evidence-based tools available to maximize the independence quality of life and confidence of their patients
Procedures Session 1 All participants will complete the initial paperwork and then be randomized into Verbal Cueing Group or Verbal Manual Cueing Group using envelopes that are predetermined from a random number table Height will be assessed using a stadiometer and weight using a scale Subjects will then have trajectory markers and surface electromyographic EMG sensors placed according to the chart This includes 24 individual marker trajectories two thigh clusters and two shank clusters of four trajectories each for a total of 40 markers and 6 surface EMG sensors that will be placed on major muscle groups of the lower extremities Once the setup has been completed and verified the subject will perform two static standing trials followed by two initial sit to stand STS trials to determine their baseline variables This format will be followed by both the Verbal Cueing and the Verbal Manual Cueing throughout the treatment session The first 5 repetitions of both groups will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task The goal of both groups is to improve midline orientation and alignment during the task of moving from sitting to standing
After the first 5 repetitions the subject will perform two sit to stand trials on their own following the clinicians scripted verbal commands Next five Manual Verbal Cueing or Verbal Cueing trials will commence followed by another two PostCue trials This repeated sequence of 5 cued trials followed by 2 assessment trials will continue for a total of 40 sit to stand trials After a 5-minute rest period the subject will then be asked to perform two additional STS to determine retention of learning over that interval Next two isometrically resisted sit to stand trials will be performed for EMG normalization Once the EMG normalization is completed the subject will then be told they are done and may get up to leave When they get up to leave their sit to stand activity will also be discretely recorded for comparison to their last knowingly observed trial This is based on the Actual Amount of Use Test AAOUT in which subjects are observed under normal circumstances to assess whether the learning was integrated into functional use when the subject doesnt think they are being observed
At the end of session 1 the investigator will ask the subject what strategy most helped them achieve midline Based on their feedback the investigator will create and issue a home exercise program HEP handout that incorporates that subjective report Examples include statements such as Feeling the pressure through my left leg or Leaning to my left This cue will be placed on a brightly colored card that will be placed near where the subject practices sitting to standing most often in their home environment The card will also contain an easy to mark log to encourage practice of the STS task over the next 3-5 days The subject will be instructed to perform the exercises at the times specified on the card using the subjects subjective to help encourage maximal midline orientation Permission will be obtained to text the subject on a regular basis to remind them to perform the exercises
Session 2 Participants who choose to return will come back within 3 to 5 days of Session 1 Subjects will be asked to bring their HEP card to verify compliance via the practice log After placement of the trajectory markers but not the EMG subjects will be asked to perform two trials of sit to stand regardless of their original group They will then be assessed with the AAOUT test in the same manner as the end of session 1 Afterward participants in the Verbal Cueing group will be offered the Integrated Cueing approach if they so choose
However the question remains for many physical therapists are skilled manual cues really an essential ingredient in the post-stroke recipe Most practicing neurologic physical therapists would claim that their hands are their most valuable tools and that the way in which they use their hands has a direct effect on movement patterns and functional outcomes with their patients Ploughman and colleagues reported that manual tactile cues during gait had robust but short-lived impacts on cadence and time in double support during gait but their findings are merely a step in the right direction An integrative approach of both manual and verbal cues have anecdotally shown to be effective to treat impairments from stroke but there continues to be a dearth of evidence to accurately support the pervasive use of manual facilitation by physical therapists While support for manual tactile cueing is merely beginning to move in the right direction strong evidence exists that task specific training can improve functional outcomes by focusing training on desired movements and activities But what part does manual cueing truly play in task specific training Sit to stand is an essential activity of daily living that is often impaired in stroke survivors and is commonly trained by physical therapists from both task specific training and NDT schools of thought Physical therapists need further clarification as to which methods are most effective for facilitating maximum learning and recovery during this functional task in order to craft an ideal recipe
Training correct movement patterns in order to improve functional independence is important at every stage of recovery after stroke Kerr et al suggested that successful sit to stand movements require proper training of the critical timing of events as well as improving synergistic activation of the appropriate lower limb musculature Ultimately asymmetry can lead to a conditioned suppression of available movement termed learned non-use Continual reinforcement of poor movement strategies thus leads to passive suppression of maximally efficient normal movements unless the stroke survivor is actively retrained to unlock masked abilities over time Teasell and colleagues confirmed the importance of skilled rehabilitation throughout all phases of recovery including the chronic stroke phase though this important population regularly experiences fewer opportunities to participate in therapy as time progresses Measurable gains may be slower at this stage but the ability to perform essential mobility tasks remains just as important to the individual
Thus the purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach during sit to stand training on the midline alignment muscle activation and quality of movement in chronic stroke survivors with hemiplegia By determining the essential ingredients that lead to an ideal recipe for success physical therapists may have more evidence-based tools available to maximize the independence quality of life and confidence of their patients
Procedures Session 1 All participants will complete the initial paperwork and then be randomized into Verbal Cueing Group or Verbal Manual Cueing Group using envelopes that are predetermined from a random number table Height will be assessed using a stadiometer and weight using a scale Subjects will then have trajectory markers and surface electromyographic EMG sensors placed according to the chart This includes 24 individual marker trajectories two thigh clusters and two shank clusters of four trajectories each for a total of 40 markers and 6 surface EMG sensors that will be placed on major muscle groups of the lower extremities Once the setup has been completed and verified the subject will perform two static standing trials followed by two initial sit to stand STS trials to determine their baseline variables This format will be followed by both the Verbal Cueing and the Verbal Manual Cueing throughout the treatment session The first 5 repetitions of both groups will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task The goal of both groups is to improve midline orientation and alignment during the task of moving from sitting to standing
After the first 5 repetitions the subject will perform two sit to stand trials on their own following the clinicians scripted verbal commands Next five Manual Verbal Cueing or Verbal Cueing trials will commence followed by another two PostCue trials This repeated sequence of 5 cued trials followed by 2 assessment trials will continue for a total of 40 sit to stand trials After a 5-minute rest period the subject will then be asked to perform two additional STS to determine retention of learning over that interval Next two isometrically resisted sit to stand trials will be performed for EMG normalization Once the EMG normalization is completed the subject will then be told they are done and may get up to leave When they get up to leave their sit to stand activity will also be discretely recorded for comparison to their last knowingly observed trial This is based on the Actual Amount of Use Test AAOUT in which subjects are observed under normal circumstances to assess whether the learning was integrated into functional use when the subject doesnt think they are being observed
At the end of session 1 the investigator will ask the subject what strategy most helped them achieve midline Based on their feedback the investigator will create and issue a home exercise program HEP handout that incorporates that subjective report Examples include statements such as Feeling the pressure through my left leg or Leaning to my left This cue will be placed on a brightly colored card that will be placed near where the subject practices sitting to standing most often in their home environment The card will also contain an easy to mark log to encourage practice of the STS task over the next 3-5 days The subject will be instructed to perform the exercises at the times specified on the card using the subjects subjective to help encourage maximal midline orientation Permission will be obtained to text the subject on a regular basis to remind them to perform the exercises
Session 2 Participants who choose to return will come back within 3 to 5 days of Session 1 Subjects will be asked to bring their HEP card to verify compliance via the practice log After placement of the trajectory markers but not the EMG subjects will be asked to perform two trials of sit to stand regardless of their original group They will then be assessed with the AAOUT test in the same manner as the end of session 1 Afterward participants in the Verbal Cueing group will be offered the Integrated Cueing approach if they so choose
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