- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07554118
Postural Control in Adults
Enhancing Postural Control in Older Adults by Increasing Somatosensory Contribution
The investigators propose a 2-week intervention involving adults over 65 years old. Participants will undergo dynamic balance training on an movable platform (stabilometer) with either restricted or full vision. The primary objective is to facilitate sensory re-weighting, hypothesizing that restricted vision training will increase somatosensory input utilization for postural control. Pre- and post-training assessments will measure postural control during gait initiation under a dual-task condition. The investigators hypothesize that the restricted vision group will demonstrate:
- Improved postural control, indicated by increased center of pressure displacement during gait initiation.
- Improved ability to utilize somatosensory input during a balance task.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants. All participants will sign written informed consent before their participation. The inclusion criteria are: 1) age 65 and above, 2) able to walk continuously for at least 10 min without assistive device, 2) have normal or corrected-to-normal vision. The exclusion criteria are: 1) neurological conditions such as stroke, Parkinson's disease, multiple sclerosis, brain tumor that significantly affect balance task and walking, 2) known peripheral neuropathy that influence sensation, 3) known vestibular dysfunction, 4) known cognitive impairments, 4) self-reported pain or musculoskeletal conditions that will significantly affect balance task and walking. Prior to enrolling in the study, the general purpose, procedures, and potential risks of the study will be explained to the potential participant and consent secured. Participants will be allocated to the no-V or the full-V group using a computerized random generator. The statistician will develop a randomization schedule and will issue it to the researchers before patient recruitment. Participants will be assigned to intervention groups using a block randomization scenario to keep the two groups even.
Baseline assessment. Demographic information will be collected in the 1st visit. Participants will complete questionnaires to record demographics and quantify physical activity level, quality of life, and psychological characteristics. Clinical outcomes regarding balance ability and proprioception assessment will also be performed. The information, surveys, and clinical outcomes collected at baseline assessments are listed in Table 1. Instrumentation. A stabilometer (Lafayette Instrument, Lafayette, IN, USA, Fig. 1) will be used for the training of the dynamic balance task. Outcome measures will be recorded in a motion analysis lab using force plates (AMTI, Watertown, MA, USA) for the center of pressure trajectory displacements. Intervention protocol. The experiment will take place over a 3-week period including screening and pre-intervention testing (1st visit), six dynamic balance training sessions (2nd to 7th visits), and post-intervention testing (8th visit). The six training sessions will be accomplished in 2 weeks. The dynamic balance training. The 2 weeks dynamic balance training involves standing and maintaining balance on a stabilometer, which consists of a platform (1.3m long by 1.4m wide) connected to a single axis that allows bidirectional sway (Lafayette Instrument Co.; Fig. 2). The maximum angular deviation of the platform is 18°. A safety harness may be provided to prevent falls but does not provide support during the performance of the task. Participants are required to maintain balance with feet in a medio-lateral orientation while standing on the balance board. A potentiometer monitors the sway angle of the platform. An integrated timer measures time in balance, which is defined as when the platform angle is within ± 5° of horizontal. The participants will be encouraged to maintain the platform in horizontal for as long as possible within a 30 s trial. Participants assigned to no-V group will perform the task with blind-fold.
Aim 1 Method Rationale. A critical component of gait, i.e. gait initiation, which is a destabilization process from static standing to continuous walking, provides an appropriate window to examine the integration of sensory and motor function. Compared to young adults, older adults demonstrate longer preparation time and reduced posterior displacement of center of pressure (CoP) trajectory as the individual prepares to accelerate the center of mass forward during gait initiation.21,22 Postural control during gait initiation are predictive of fall risk and have been used to examine the effects of selective interventions on sensorimotor integration during walking.38,39 This has direct clinical implications, as gait initiation is ecologically relevant to walking. Instrumentation. A force plate (AMTI, Watertown, MA, USA) will be used to capture the trajectory of the center of pressure during gait initiation. Procedures. Gait initiation will be performed at the pre-intervention and post-intervention testing. The participants will stand on a force plate with both legs, feet are should-width apart. The participant will be instructed to perform mathematic calculations (i.e. subtract seven consecutively from a three-digit number) and speak out the answers while standing on a force plate. The participants will be instructed to initiate walking while performing the cognitive tasks. They will be walking along a 7 m walk way as quickly as they safely can after a visual LED cue indicates the side of leg for gait initiation. The participant will be asked to continue walking for 3 m for one walking trial. Data processing and analysis. The posterior displacement of the center of pressure (CoP) will be measured by the displacement of the CoP trajectory from the initial CoP position to the maximum posterior position in the anterior-posterior direction (Fig 3). Expected outcomes. After 2 weeks of the dynamic balance training, The investigators expect to see a greater increase in the posterior displacement of the CoP trajectory during gait initiation in the no-V group (Fig 4).
Aim 2 Method Rationale. The Modified Clinical Test for Sensory Interaction on Balance (CTSIB-M) is used clinically for balance analysis and to determine the dependence of the individual on all sensory systems (i.e. vision, vestibular and somatosensory) during balance tasks. The CTSIB-M has been shown to have excellent reliability in older adults and predictive to future fall incidence 40,41. Procedures. To perform the CTSIB-M, the participants stands with their hands at their side with the goal to stand as steady as possible for 30 s, under four different conditions (i.e. stand on firm surface with eyes-open, stand on firm surface with eyes-closed, stand on compliant surface with eyes-open, stand on compliant surface with eyes-closed). The investigators will collect three trials in each condition. Each trial will be timed with a stop watch, and the timer stops when the participant moves their arms, shows more than minimal body sway, and lose their balance or take a step. The test will be carried out on a force plate which will record the center of pressure trajectory for a secondary quantitative analysis regarding the amplitude of body sway. Data processing and analysis. The time in balance of the four conditions will be compared pre- and post- intervention using repeated measures ANOVA. Expected outcomes. The investigators expect that the no-V group will show improved time in balance in the "stand on firm surface with eyes-closed" condition which focuses on to evaluate the contribution of somatosensory inputs during the standing balance task.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yo Shih, PhD
- Phone Number: 405-271-2131
- Email: Yo-shih@ou.edu
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73117
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Yo Shih, PhD
- Phone Number: 405-353-2602
- Email: yo-shih@ou.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 65 and above
- able to walk continuously for at least 10 min without assistive device
- have normal or corrected-to-normal vision.
Exclusion Criteria:
- neurological conditions such as stroke, Parkinson's disease, multiple sclerosis, brain tumor that significantly affect balance task and walking
- known peripheral neuropathy that influence sensation
- known vestibular dysfunction
- known cognitive impairments
- self-reported pain or musculoskeletal conditions that will significantly affect balance task and walking.
- Drug use in the past 3 month.
- At-risk drinker -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: restricted vision (no-V)
The participant will be blind-folded in the following dynamic balance training.
The 2 weeks dynamic balance training involves standing and maintaining balance on a stabilometer, which consists of a platform (1.3m long by 1.4m wide) connected to a single axis that allows bidirectional sway (Lafayette Instrument Co.; Fig. 2).
The maximum angular deviation of the platform is 18°.
A safety harness may be provided to prevent falls but does not provide support during the performance of the task.
Participants are required to maintain balance with feet in a medio-lateral orientation while standing on the balance board.
A potentiometer monitors the sway angle of the platform.
An integrated timer measures time in balance, which is defined as when the platform angle is within ± 5° of horizontal.
The participants will be encouraged to maintain the platform in horizontal for as long as possible within a 30 s trial.
Participants assigned to no-V group will perform the task with blind-fold.
|
no-V group will perform the dynamic balance task with blind-fold. The 2 weeks dynamic balance training involves standing and maintaining balance on a stabilometer, which consists of a platform (1.3m long by 1.4m wide) connected to a single axis that allows bidirectional sway (Lafayette Instrument Co.; Fig. 2). The maximum angular deviation of the platform is 18°. A safety harness may be provided to prevent falls but does not provide support during the performance of the task. Participants are required to maintain balance with feet in a medio-lateral orientation while standing on the balance board. A potentiometer monitors the sway angle of the platform. An integrated timer measures time in balance, which is defined as when the platform angle is within ± 5° of horizontal. The participants will be encouraged to maintain the platform in horizontal for as long as possible within a 30 s trial. Participants assigned to no-V group will perform the task with blind-fold. |
|
Active Comparator: full vision (full-V)
The participants in this arm will be doing the dynamic balance training with eyes open. The 2 weeks dynamic balance training involves standing and maintaining balance on a stabilometer, which consists of a platform (1.3m long by 1.4m wide) connected to a single axis that allows bidirectional sway (Lafayette Instrument Co.; Fig. 2). The maximum angular deviation of the platform is 18°. A safety harness may be provided to prevent falls but does not provide support during the performance of the task. Participants are required to maintain balance with feet in a medio-lateral orientation while standing on the balance board. A potentiometer monitors the sway angle of the platform. An integrated timer measures time in balance, which is defined as when the platform angle is within ± 5° of horizontal. The participants will be encouraged to maintain the platform in horizontal for as long as possible within a 30 s trial. Participants assigned to no-V group will perform the task with blind-fold |
The participants will be performing the dynamic balance training with their full vision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic postural control
Time Frame: From enrollement to one week within the last training days (within 3 weeks from enrollment)
|
The center of pressure displacement during gait initiation under a single and a dual-task condition will be measured.
|
From enrollement to one week within the last training days (within 3 weeks from enrollment)
|
|
Somatosensory reliance during static standing
Time Frame: From enrollment to within one week after the last day of training (within three weeks from enrollment)
|
The center of pressure displacement during static standing with eye-closed.
|
From enrollment to within one week after the last day of training (within three weeks from enrollment)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yo Shih, PhD, University of Oklahoma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17943P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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