Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04498429 |
| Other study ID # |
5200090 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 6, 2020 |
| Est. completion date |
August 24, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Loma Linda University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 1950's, 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 clinician's 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 doesn't 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 subject's 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.
