跳至主要内容
临床试验/NCT07460804
NCT07460804招募中不适用

Focus of Attention Effect on Sit to Stand Symmetry in Individuals Post Chronic Stroke: A Randomized Cross-over Trial

Western Carolina University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Center of pressure under their feet

研究概览

简要总结

The purpose of this study is to fill some gaps in the literature by examining the effects of focus of attention on motor learning and motor performance of sit to stand in individuals post chronic stroke. This study will investigate whether an internal or external focus of attention can lead to improved use of the affected lower extremity during the sit to stand transition, while maintaining an upright trunk position. More specifically, the study has two purposes. The first is to determine whether an external or internal focus of attention would lead to better motor learning of sit to stand. This is measured by retention testing and transfer of the task to changes in affected lower extremity weight bearing during gait. The second purpose of this study is to investigate whether an internal or external focus of attention affects the performance of sit to stands during training.

详细描述

Participant demographics and clinical information will be collected, including age, gender, weight, height, location of stroke, how long ago the stroke occurred, and fall history. All participants will consent to participation in this study. The Star Cancellation Test, NIH Stroke Scale (NIHSS), and Montreal Cognitive Assessment (MOCA) will be used to determine eligibility. Fugl Meyer Motor Scale for the lower extremity, excluding reflexes, will also be completed to help describe the sample. Blood pressure, heart rate, and oxygen saturation, via a pulse oximeter, will be taken and a gait belt will be placed on the participant prior to the start of baseline measures. Temporospatial gait parameters will be collected using the GAITRite mat at baseline, 5 minutes after training, and 1 hour after training. Temporospatial gait parameters will be averaged across four passes over the GAITRite mat at each measurement session. Participants will be instructed to 'walk past the end of the mat at your normal comfortable pace'.

Participants will then be seated on a hi-lo table with their feet on the HR pressure mat for baseline assessment of sit to stand. Initial mat height will be determined by raising or lowering the mat table until the femur is parallel to the floor. In order to determine this, a level will be lined up from the greater trochanter to the lateral femoral condyle, while the fibula, from fibular head to lateral malleolus, is perpendicular to the floor. This initial mat position will be the height used during each reassessment at baseline, 5 minutes after training, and 1 hour post training. This height will also be used to decide the mat positions needed during training. After the initial mat height is achieved and recorded, an IMU marker will be placed on the superior third of the sternum directly inferior to the sternal notch.

After the mat table height is set, participants will be asked to stand up and sit down to determine comfortable foot placement in relation to their knees. The toe of the affected lower extremity will be lined up with the toe of the unaffected side once they have achieved a comfortable foot placement. Tape marks will be placed in front of the toes and on the lateral edges of both feet as well as around the buttocks to allow for a standardized starting position for all assessment timepoints. For all data collection during baseline, 5 minutes post, and 1 hour post training, participants will be instructed to "please stand up three times at your normal speed without your arms if possible". The average force under the affected foot and the average overall force beneath both feet during the sit to stand transition will be captured by the HR pressure mat. The maximal lateral trunk position will be captured throughout this transition by the IMU marker. If individuals need to use their upper extremities this should be recorded.

After baseline data collection, participants will be randomized into either the internal or external focus condition. Initial condition allocation will be determined by a random number generator (https://www.random.org), blocks of 6 with a 1:1 ratio. Condition assignment will be sealed in envelopes numbered for each participant by an independent researcher, who will otherwise not be involved in this research study. Condition allocation envelops will be opened directly prior to acquisition trials so baseline assessors will be blinded to group assignment of participants. Participants will be blinded to initial group assignment throughout the entirety of the sessions.

Training Prior to training, a demonstration of the task will be provided to the participants. Those in the external focus condition will be told, "as you stand up and as you sit down try to bring the targets together like this". Those in the internal focus condition will be told, "as you stand up and as you sit down bring your right/left (R/L) shoulder and R/L hip as far to the R/L as possible." Participants will be asked to perform one repetition with the question "can you show me?". The demonstration is only provided before the first set but these same instructions will be given prior to the start of each successive set during training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will not be aware of their condition allocation compared to the other condition.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke >6 months
  • Mild to moderate stroke (NIHSS scores 0-15)

排除标准

  • Unable to perform sit to stand from a standard height 20" chair without physical assistance
  • Unable to walk 20 feet with or without an assistive device at a contact guard to independent level
  • Individuals with severe cognitive impairment (<10/30 on the Montreal Cognitive assessment)
  • Contraversive pushing (> 1 on the Scale for 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.
  • Minors, prisoners, pregnant women will also be excluded.
  • Non English speaking individuals due to lack of interpretation resources.

研究组 & 干预措施

Internal focus of attention group

Active Comparator

Participants were given instructions that make them think about their body's movements.

Prior to training, a demonstration of the task was provided to the participants with emphasis to weight shift towards the affected side. For the internal focus condition, participants were told, "as you stand up and as you sit down bring your right/left (R/L) shoulder and R/L hip as far to the R/L as possible." Participants were asked to perform one repetition with the question "can you show me?" The demonstration was only provided before the first set, but the same verbal instructions were given prior to the start of each successive set during training. During training, individuals performed four sets of 10 sit to stand repetitions, yielding a total of 40 repetitions.

干预措施: Focus of Attention (Other)

External focus of attention group

Experimental

Participants were given instructions that make them think about an outside target/outcome.

Prior to training, a demonstration of the task was provided to the participants with emphasis to weight shift towards the affected side. For the internal focus condition, participants were told, "as you stand up and as you sit down try to bring the targets together like this." Participants were asked to perform one repetition with the question "can you show me?" The demonstration was only provided before the first set, but the same verbal instructions were given prior to the start of each successive set during training. During training, individuals performed four sets of 10 sit to stand repetitions, yielding a total of 40 repetitions.

干预措施: Focus of Attention (Other)

结局指标

主要结局

Center of pressure under their feet

时间窗: 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

时间窗: 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

时间窗: Immediate Post (5 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

时间窗: Long term (one hour 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.

Trunk alignment

时间窗: 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

时间窗: 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

时间窗: Immediate Post (5 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

时间窗: Long term (one hour after 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.

Post Manipulation Questionnaire

时间窗: Long term (after all measures completed 1 hour after training)

To establish whether participants were thinking about what they were instructed, all individuals were given a post manipulation questionnaire after the 1-hour post training retention testing for each condition. Participants were asked to rate how much they were thinking about "a target that is outside of your body," "how you move your body (e.g. shoulders, hips, trunk)," and about "something else." They responded on a Likert scale with 5 representing very much so and 1 to represent not at all.

次要结局

  • % of Gait Cycle in Stance on Affected LE(Long term (one hour after acquisition/training))
  • % of Gait Cycle in Stance on Affected LE(Baseline)
  • % of Gait Cycle in Stance on Affected LE(Immediate Post (5 minutes after acquisition training))
  • Step Length of Unaffected LE During Gait(Baseline)
  • Step Length of Unaffected LE During Gait(Immediate Post (5 minutes after acquisition))
  • Step Length of Unaffected LE During Gait(Long term (1 hour after acquisition))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Watamura

Assistant Professor

Western Carolina University

研究点 (1)

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