NCT05125172

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 day until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

October 6, 2021

Last Update Submit

November 7, 2021

Conditions

Keywords

Motor learningFocus of attentionSit to stand

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 COMPARATOR

Participants 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.

Other: Focus of Attention

External focus of attention group

EXPERIMENTAL

Participants 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.

Other: Focus of Attention

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.

External focus of attention groupInternal focus of attention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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
Model Details: Randomized cross-over study. Participants will be randomized into the internal or external focus of attention group and one week later they will complete the opposite protocol.
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

Locations