Clinical trial NCT04696302: Focus of Attention in Individuals With Stroke
Official title: Focus of Attention Effects on Motor Performance and Learning in Individuals Post Stroke During Seated Lateral Weight Shifting: A Two-phase Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Focus of attention
Motor learning
Seated weight shifting
Lead sponsor: Western Carolina University
Sponsor class: OTHER
Collaborators: name: Mission Health System, Asheville, NC
First posted: 2021-01-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two independent groups measured at 4 timepoints, baseline, acquisition, short-term, and long-term retention.
Primary purpose: TREATMENT

Brief summary: This two phase feasibility study looked at the feasibility of conducting a clinical trial in the outpatient and inpatient rehab setting exploring how individuals post stroke respond to different focus of attention cues. Focus of attention refers to whether individuals in are thinking about how their body is moving, internal focus, or on the effect their body has on the environment, external focus, during motor task. This trial will specifically look at the effect focus of attention has on motor performance and learning in individuals post stroke during lateral seated weight shifting task.

Detailed description: This was a two phase feasibility study exploring appropriate management, setting, participants including inclusion and exclusion criteria, attrition rates, protocol, and retention. Outcome data for each stage were collected during baseline, acquisition, short-term, and long-term retention.

There were two primary objectives of this two phase feasibility study. The first was to uncover some potential short comings in research designs used in this area. The second was to explore the feasibility of a study in both the chronic and acute stroke populations in a rural community. Topics of feasibility include recruitment, retention, and specific inclusion and exclusion criteria. Extending the work by Muckel and Merholz, this feasibility study examined performance of individuals post stroke during a seated lateral weight shifting task and incorporated retention trials, quality of movement exploration, and bilateral weight shifting.

During Phase I, individuals in both groups sat unsupported on a hi-lo mat table which was adjusted so participants were sitting at 90 degrees hip and knee flexion with feet shoulder width apart. Tape marks were used to mark initial set up ensuring standardized positioning for each trial. Following baseline trials, all participants watched the same instructional video describing lateral weight shifting. The instructions included correct mechanics that should be used when weight shifting laterally with focus on correct form needed for the movement.

Testing included baseline, acquisition, short term retention (5 minutes later), and long-term retention (7-10 days later). Participants performed three trials of seated weight shifting to each side at all timepoints. During acquisition, the internal focus group was instructed to "shift your weight as much as possible towards your right or left hip without using your arms". The external focus group sat with targets one arm length away at shoulder height and were instructed to "shift your body weight as much as possible towards the blue/orange target without using your arms." During baseline and retention trials, adults were instructed to "lean as far as you can to the right/left without using your arms." During Phase II, the protocol was similar except 6 trials were performed for acquisition to potentially improve motor learning, which was not significant in Phase I per retention data. Other changes to the protocol included allowing participants to move their feet when weight-shifting. Instructions were also revised. The external focus group was told to "move your shoulder as close to the blue/orange target as possible", while the internal focus group was told to "shift your body weight as much as possible towards your right/left hip without using your arms."

Eligibility criteria: Inclusion Criteria:

* participants with history of stroke
* ability to sit statically without physical assistance

Exclusion Criteria:

* severe hemineglect (star cancellation test \<44/54)
* inability to follow multistep commands
* orthopedic issues that limited their ability to weight shift including severe hip or back pain
* individuals with other neurologic conditions such as dementia
* individuals with contraversive pushing.

During the first arm (phase) of the study there were age matched healthy controls.

Primary outcomes:
measure: Recruitment
timeFrame: One year for each arm of the study.
measure: Retention
timeFrame: One year for each arm of the study.
Secondary outcomes:
measure: Shoulder alignment during baseline to affected side
timeFrame: baseline (prior to training)
measure: Shoulder alignment during baseline to unaffected side
timeFrame: baseline (prior to training)
measure: Shoulder alignment during acquisition or training to affected side
timeFrame: acquisition (30 minutes) through study completion, average of one year.
measure: Shoulder alignment during acquisition or training to unaffected side
timeFrame: acquisition (30 minutes) through study completion, average of one year.
measure: Shoulder alignment during short term retention to affected side
timeFrame: short-term (5 minutes after training)
measure: Shoulder alignment during short term retention to unaffected side
timeFrame: short-term (5 minutes after training)
measure: Shoulder alignment during long term retention to affected side
timeFrame: long-term (7 days after training)
measure: Shoulder alignment during long term retention to unaffected side
timeFrame: long-term (7 days after training)
measure: Seated lateral excursion during baseline to affected side
timeFrame: baseline (prior to training)
measure: Seated lateral excursion during baseline to unaffected side
timeFrame: baseline (prior to training)
measure: Seated lateral excursion during acquisition or training to affected side
timeFrame: acquisition (30 minutes) through study completion, average of one year.
measure: Seated lateral excursion during acquisition or training to unaffected side
timeFrame: acquisition (30 minutes) through study completion, average of one year.
measure: Seated lateral excursion during short-term retention to affected side
timeFrame: short-term (5 minutes after training)
measure: Seated lateral excursion during short-term retention to unaffected side
timeFrame: short-term (5 minutes after training)
measure: Seated lateral excursion during long-term retention to affected side
timeFrame: long-term (7 days after training)
measure: Seated lateral excursion during long-term retention to unaffected side
timeFrame: long-term (7 days after training)
Other outcomes:
Locations:
city: Cullowhee
country: United States
facility: Western Carolina University
state: North Carolina
Study officials:
affiliation: Western Carolina University
name: Ashley W Hyatt, DPT
role: PRINCIPAL_INVESTIGATOR
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