Focus of Attention Effect on Sit to Stand Symmetry in Individuals Post Stroke
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to explore whether an external focus or internal focus of attention leads to improved motor performance and learning with increased use of the affected side during sit to stand in individuals post stroke. Focus of attention refers to what a person is thinking about during a task, with an internal focus being thinking about what one's body is doing and an external focus being thinking about a target or outcome in the environment. A second purpose is to determine whether improved symmetry in sit to stand carries over to gait symmetry in individuals post stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Oct 2021
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2021
CompletedStudy Start
First participant enrolled
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedNovember 18, 2021
November 1, 2021
8 months
October 6, 2021
November 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Center of pressure under their feet
HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.
Baseline
Center of pressure under their feet
HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.
Acquisition (one 1 hour training)
Center of pressure under their feet
HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.
Immediate Post (2 minutes after acquisition training)
Center of pressure under their feet
HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.
Short term (20 minutes after post data collection)
Center of pressure under their feet
HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.
Long term (one hour after post data collection)
Trunk alignment
IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.
Baseline
Trunk alignment
IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.
Acquisition (one 1 hour training)
Trunk alignment
IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.
Immediate Post (2 minutes after acquisition training)
Trunk alignment
IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.
Short term (20 minutes after post data collection)
Trunk alignment
IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.
Long term (one hour after post data collection)
5 times sit to stand
Five Times Sit to Stand will also be an outcome measure used at baseline, immediately after training, during short term retention (20 min after training) and long term retention (1 hour after training).
Baseline
5 times sit to stand
Five Times Sit to Stand will also be an outcome measure used at baseline, immediately after training, during short term retention (20 min after training) and long term retention (1 hour after training).
Immediate Post (2 minutes after acquisition training)
5 times sit to stand
Five Times Sit to Stand will also be an outcome measure used at baseline, immediately after training, during short term retention (20 min after training) and long term retention (1 hour after training).
Short term (20 minutes after post data collection)
5 times sit to stand
Five Times Sit to Stand will also be an outcome measure used at baseline, immediately after training, during short term retention (20 min after training) and long term retention (1 hour after training).
Long term (one hour after post data collection)
Secondary Outcomes (4)
Gait symmetry
Baseline
Gait symmetry
Immediate Post (2 minutes after acquisition training)
Gait symmetry
Short term (20 minutes after post data collection)
Gait symmetry
Long term (one hour after post data collection)
Study Arms (2)
Internal focus of attention group
ACTIVE COMPARATORParticipants will be given instructions that make them think about their body's movements. Participants will complete the external focus group second in the cross over.
External focus of attention group
EXPERIMENTALParticipants will be given instructions that make them think about an outside target or outcome. Participants will complete the internal focus group second in the cross over.
Interventions
Focus of attention instruction and feedback. Focus of attention refers to what people are thinking about during motor tasks. An external focus refers to thinking about an outside outcome or target. An internal focus of attention refers to thinking about how someone is moving their body.
Eligibility Criteria
You may qualify if:
- Stroke \>1 month
- Must be able to perform sit to stand from a standard height 20" chair without physical assistance
- Must be able to walk 20 feet with or without an assistive device at a contact guard to independent level
- Follow 3 step motor commands.
You may not qualify if:
- Contraversive pushing
- Neglect as evidenced by \<44/54 on the star cancellation test
- Any orthopedic conditions that impact their ability to transition from sit to stand will be excluded from the study.
- Any other neurologic conditions that impact their ability to transition from sit to stand will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Carolina University
Cullowhee, North Carolina, 28723, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not be aware of their group allocation compared to the other group.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 6, 2021
First Posted
November 18, 2021
Study Start
October 7, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
November 18, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share