StrokeNCT05125172
Focus of Attention Effect on Sit to Stand Symmetry in Individuals Post Stroke
A study testing Focus of Attention in people with Stroke, run by Western Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Focus of Attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Carolina University
Cullowhee, North Carolina, 28723
About this study
Official title: Focus of Attention Effect on Sit to Stand Symmetry in Individuals Post Stroke: A Randomized Cross-over Trial.
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.
Read the detailed description
Participant demographics including age, gender, weight, and height will be collected. Self-selected gait speed, temporospatial gait parameters, and 5 Times Sit to Stand, will be collected at baseline, immediately after, during short term retention (20 minutes after training), and long term retention (one hour after training is completed). Gait speed and temporospatial parameters will be averaged across four passes over the GaitRite mat with participants being instructed to 'walk past the end of the mat at a normal comfortable pace'. The 5 Times Sit to Stand test will be completed from an 20" height and participants will be instructed, "Stand up and sit down 5 times as quickly as possible without using arms".
Participants will then be seated on a pressure mat placed on hi-lo table at a height where the participant's thigh is parallel to the floor, with an IMU marker on the manubrium. The participant's feet will be placed on an HR pressure mat at a comfortable width with toes being in line with one another. Tape marks will be placed at initial foot and buttocks position to allow for a consistent positioning throughout all trials. For baseline measurement, participants will perform sit to stand three times. During baseline, participants will be instructed to "please stand up without arms if possible". Immediately post training, during short term, and long term retention participants will be told, "using the strategy used during training, please stand up without using arms three times" and "please stand up normally". Average force under the affected side/average overall force during the sit to stand transition will be captured on the HR pressure mat located beneath the participants feet.
Participants will be categorized into groups based on stroke chronicity with those who have had a stroke within 6 months being placed in the subacute group and those with a stroke greater than 6 months being categorized in the chronic group. Within their stroke category they will be randomized into either the internal or external focus group using a random number generator. Each participant will perform 3 trials of sit to stand at baseline, short term, and long-term retention. During training, participants will perform sets of sit to stands with the mat at progressively lower heights, with differing cues based on group allocation. One set of sit to stands to 10 or form fatigue or RPE rating >16/20 will occur 30% above baseline, 20%, and 10% of the starting mat height. If participants are unable to complete 10 the number completed will be recorded for each trial. Two minute rest breaks will occur between each set or until the paricipant reports a rate of perceived exertion (RPE) of <11/20 on the Borg RPE scale.
Prior to training the participants will be given a demonstration. The external focus group will be told, "Stand up and sit down trying to keep the orange targets and the blue targets as close together as possible, like this." The internal focus group will be told, "Stand up and sit down trying to keep the R/L shoulder and R/L hip as far to the R/L as possible, like this." Participants will be asked to perform one repetition, "show me". Corrections will be given based on participant performance and group allocation.
During acquisition trials the external focus group will have foam circles taped to their lateral shoulder and lateral hip. Matching circles will be placed half the body width plus 10cm to their side in line with the feet. See figure 2. This distance will be determined by taking the girth in sitting. Participants will be instructed to 'bring the targets together as participants stand up. The internal focus group will be instructed to bring the left/right shoulder and hip as far to the left/right as possible. Feedback will be provided according to group allocation.
Center of pressure beneath the feet at the maximum lateral excursion towards the affected side, as well as the average throughout sit to stand will be analyzed at baseline, during acquisition trials, immediately after training, 20 minutes later, and 1 hour after training. Trunk alignment will also be captured at these same times with the IMU.
During the 20 minutes between the training and short term data collection participants will complete a post manipulation questionnaire regarding what participants were thinking about during sit to stand training. During the hour between short term and long-term retention participants will complete a general health questionnaire and the Montreal Cognitive Assessment (MOCA) to explore cognitive status.
One week later participants will return and complete the same protocol in the opposite group initially assigned. Both sessions should last less than two hours.
- Conditions
- Stroke
- Being tested
- Focus of Attention
- Keywords
- Motor learning, Focus of attention, Sit to stand
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus of AttentionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Focus of Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Long term (one hour after post data collection)
Secondary outcomes (4)
Gait symmetry
GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time.
Measured: Baseline
Gait symmetry
GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time.
Measured: Immediate Post (2 minutes after acquisition training)
Gait symmetry
GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time.
Measured: Short term (20 minutes after post data collection)
Gait symmetry
GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time.
Measured: Long term (one hour after post data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start7 Oct 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Hyatt, Western Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125172
- Sponsor's protocol ID
- 1799540-1
- Status last verified
- Nov 2021
- First submitted
- 6 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus of Attention Effect on Sit to Stand Symmetry in Individuals Post Stroke: A Randomized Cross-over Trial.
- ClinicalTrials.gov ID
- NCT05125172
- Acronym / sponsor ID
- 1799540-1
- Conditions
- Stroke
- Keywords
- Motor learning, Focus of attention, Sit to stand
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western Carolina UniversityUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participant demographics including age, gender, weight, and height will be collected. Self-selected gait speed, temporospatial gait parameters, and 5 Times Sit to Stand, will be collected at baseline, immediately after, during short term retention (20 minutes after training), and long term retention (one hour after training is completed). Gait speed and temporospatial parameters will be averaged across four passes over the GaitRite mat with participants being instructed to 'walk past the end of the mat at a normal comfortable pace'. The 5 Times Sit to Stand test will be completed from an 20" height and participants will be instructed, "Stand up and sit down 5 times as quickly as possible without using arms".
Participants will then be seated on a pressure mat placed on hi-lo table at a height where the participant's thigh is parallel to the floor, with an IMU marker on the manubrium. The participant's feet will be placed on an HR pressure mat at a comfortable width with toes being in line with one another. Tape marks will be placed at initial foot and buttocks position to allow for a consistent positioning throughout all trials. For baseline measurement, participants will perform sit to stand three times. During baseline, participants will be instructed to "please stand up without arms if possible". Immediately post training, during short term, and long term retention participants will be told, "using the strategy used during training, please stand up without using arms three times" and "please stand up normally". Average force under the affected side/average overall force during the sit to stand transition will be captured on the HR pressure mat located beneath the participants feet.
Participants will be categorized into groups based on stroke chronicity with those who have had a stroke within 6 months being placed in the subacute group and those with a stroke greater than 6 months being categorized in the chronic group. Within their stroke category they will be randomized into either the internal or external focus group using a random number generator. Each participant will perform 3 trials of sit to stand at baseline, short term, and long-term retention. During training, participants will perform sets of sit to stands with the mat at progressively lower heights, with differing cues based on group allocation. One set of sit to stands to 10 or form fatigue or RPE rating >16/20 will occur 30% above baseline, 20%, and 10% of the starting mat height. If participants are unable to complete 10 the number completed will be recorded for each trial. Two minute rest breaks will occur between each set or until the paricipant reports a rate of perceived exertion (RPE) of <11/20 on the Borg RPE scale.
Prior to training the participants will be given a demonstration. The external focus group will be told, "Stand up and sit down trying to keep the orange targets and the blue targets as close together as possible, like this." The internal focus group will be told, "Stand up and sit down trying to keep the R/L shoulder and R/L hip as far to the R/L as possible, like this." Participants will be asked to perform one repetition, "show me". Corrections will be given based on participant performance and group allocation.
During acquisition trials the external focus group will have foam circles taped to their lateral shoulder and lateral hip. Matching circles will be placed half the body width plus 10cm to their side in line with the feet. See figure 2. This distance will be determined by taking the girth in sitting. Participants will be instructed to 'bring the targets together as participants stand up. The internal focus group will be instructed to bring the left/right shoulder and hip as far to the left/right as possible. Feedback will be provided according to group allocation.
Center of pressure beneath the feet at the maximum lateral excursion towards the affected side, as well as the average throughout sit to stand will be analyzed at baseline, during acquisition trials, immediately after training, 20 minutes later, and 1 hour after training. Trunk alignment will also be captured at these same times with the IMU.
During the 20 minutes between the training and short term data collection participants will complete a post manipulation questionnaire regarding what participants were thinking about during sit to stand training. During the hour between short term and long-term retention participants will complete a general health questionnaire and the Montreal Cognitive Assessment (MOCA) to explore cognitive status.
One week later participants will return and complete the same protocol in the opposite group initially assigned. Both sessions should last less than two hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Internal focus of attention group | Active comparator | Other: Focus of AttentionParticipants 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 | Experimental | Other: Focus of AttentionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus of AttentionFocus 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. | Other | External focus of attention group, Internal focus of attention group |
Primary outcome
Center of pressure under their feet
Time frame: Baseline
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.
Center of pressure under their feet
Time frame: Acquisition (one 1 hour training)
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.
Center of pressure under their feet
Time frame: Immediate Post (2 minutes after acquisition training)
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.
Center of pressure under their feet
Time frame: Short term (20 minutes after post data collection)
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.
Center of pressure under their feet
Time frame: Long term (one hour after post data collection)
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.
Trunk alignment
Time frame: Baseline
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.
Trunk alignment
Time frame: Acquisition (one 1 hour training)
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.
Trunk alignment
Time frame: Immediate Post (2 minutes after acquisition training)
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.
Trunk alignment
Time frame: Short term (20 minutes after post data collection)
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.
Trunk alignment
Time frame: Long term (one hour after post data collection)
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.
5 times sit to stand
Time frame: Baseline
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).
5 times sit to stand
Time frame: Immediate Post (2 minutes after acquisition training)
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).
5 times sit to stand
Time frame: Short term (20 minutes after post data collection)
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).
5 times sit to stand
Time frame: Long term (one hour after post data collection)
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).
4 secondary outcomes
Gait symmetry
Time frame: Baseline
Gait symmetry
Time frame: Immediate Post (2 minutes after acquisition training)
Gait symmetry
Time frame: Short term (20 minutes after post data collection)
Gait symmetry
Time frame: Long term (one hour after post data collection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus of Attention in people with Stroke, run by Western Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of pressure under their feet (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.