Focus of Attention Effect on Sit to Stand Symmetry in Individuals Post Stroke
NCT ID: NCT05125172
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-10-07
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Internal focus of attention group
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.
Focus of Attention
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 group
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.
Focus of Attention
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Focus of Attention
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Western Carolina University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ashley Hyatt
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Western Carolina University
Cullowhee, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1799540-1
Identifier Type: -
Identifier Source: org_study_id