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Clinical Trials/NCT04696302
NCT04696302
Completed
Not Applicable

Focus of Attention Effects on Motor Performance and Learning in Individuals Post Stroke During Seated Lateral Weight Shifting: A Two-phase Feasibility Study

Western Carolina University1 site in 1 country38 target enrollmentMarch 23, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Accident
Sponsor
Western Carolina University
Enrollment
38
Locations
1
Primary Endpoint
Recruitment
Status
Completed
Last Updated
5 years ago

Overview

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."

Registry
clinicaltrials.gov
Start Date
March 23, 2015
End Date
May 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ashley Hyatt

Assistant Professor of Physical Therapy

Western Carolina University

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.

Outcomes

Primary Outcomes

Recruitment

Time Frame: One year for each arm of the study.

Percentage of participants recruited out of the estimated number needed by power analysis. Power analyses revealed 42 participants were needed for 2X4 mixed model ANOVA 193 analysis, a=.05, power=.8, with a medium effect size, f=.2.

Retention

Time Frame: One year for each arm of the study.

Percentage of participants that completed all 4 timepoints, baseline, acquisition, short term, and long term retention out of those that completed baseline trials.

Secondary Outcomes

  • Shoulder alignment during long term retention to unaffected side(long-term (7 days after training))
  • Shoulder alignment during baseline to affected side(baseline (prior to training))
  • Shoulder alignment during short term retention to affected side(short-term (5 minutes after training))
  • Shoulder alignment during baseline to unaffected side(baseline (prior to training))
  • Shoulder alignment during acquisition or training to unaffected side(acquisition (30 minutes) through study completion, average of one year.)
  • Shoulder alignment during acquisition or training to affected side(acquisition (30 minutes) through study completion, average of one year.)
  • Shoulder alignment during short term retention to unaffected side(short-term (5 minutes after training))
  • Seated lateral excursion during baseline to affected side(baseline (prior to training))
  • Seated lateral excursion during acquisition or training to affected side(acquisition (30 minutes) through study completion, average of one year.)
  • Shoulder alignment during long term retention to affected side(long-term (7 days after training))
  • Seated lateral excursion during baseline to unaffected side(baseline (prior to training))
  • Seated lateral excursion during acquisition or training to unaffected side(acquisition (30 minutes) through study completion, average of one year.)
  • Seated lateral excursion during short-term retention to affected side(short-term (5 minutes after training))
  • Seated lateral excursion during short-term retention to unaffected side(short-term (5 minutes after training))
  • Seated lateral excursion during long-term retention to unaffected side(long-term (7 days after training))
  • Seated lateral excursion during long-term retention to affected side(long-term (7 days after training))

Study Sites (1)

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