Clinical Trials Logo

Clinical Trial Summary

Stroke is the leading cause of serious long-term disability in the United States. Walking speed is related to stroke severity and how well someone can return to community life. Biofeedback is a useful method for increasing walking speed in persons post-stroke, however, these methods are typically limited to laboratory settings. The objective of this research is to determine the short-term response and training potential of a novel, wearable device that provides visual feedback of hip extension during unconstrained over ground walking. The aims of this study are to 1) determine short-term effects of visual biofeedback on biomechanical outcomes, 2) determine the short-term effects of visual biofeedback on gait symmetry during overground walking in individuals post-stroke. The investigators hypothesize that biomechanical and spatiotemporal outcomes will improve following training with the wearable biofeedback device. To assess these aims, participants' gait biomechanics will be assessed pre- and post-training with the biofeedback device as well as 24-hours following the training. Walking speed (primary outcome) as well as hip extension angle, propulsive force, step width, step length, and step time will be assessed to determine changes in performance with use of the device. By understanding short-term responses to this novel training paradigm, research can begin assessing the potential of wearable biofeedback devices in improving gait in persons post-stroke. Should this training prove successful, this study will provide the necessary feasibility data to motivate a larger scale, case-control clinical trial to determine efficacy of the device and training.

Clinical Trial Description

For all aims, participants will complete a first testing session where biomechanical variables will be assessed pre- and post-training with the hip extension device. A second testing session will be completed 24-hours following the first session where retention of training will be assessed. Biomechanical assessments, control sessions and training sessions are described as follows: Biomechanical Assessments: Biomechanical Assessments will be performed to assess variables including walking speed, hip extension angle, and propulsion. Retro-reflective markers will be placed over anatomical landmarks using a lower-body marker set. Participants will be instructed to walk in a straight line over a set of embedded force platforms (AMTI) while a 17-camera motion capture system (Motion Analysis Corp.) records lower-body kinematics and kinetics. Participants will complete a total of three successful walking trials for each assessment with a successful trial being defined as having at least one clean foot strike in a force platform for each foot. No biofeedback will be provided during biomechanical assessments. During the biomechanical assessments, subjects may wear a harness suspended from the ceiling (no body-weight support) for safety. Control Session: Prior to training, participants will undergo assessments without biofeedback. This session will be used as a comparison for the effects of a single training session. Training: Participants will complete three training bouts in a session. For these training bouts, participants will be instructed to walk around the perimeter of the 9m x 15m laboratory while wearing the custom gait biofeedback device and visual display glasses. The training bouts will each be 6 minutes in duration with a 5-minute break in between bouts. The same training structure was successfully used in a previous study10. The biofeedback will be intermittent, with one minute on and one minute off, in order for the individual to not become dependent on the feedback and to promote motor learning. Participants will be told that the device measures the angle their paretic leg is at, and as they move their leg, the line on the screen will move. They will be shown as they move their leg farther back, the line moves up, closer to the target. Participants will not be given specific feedback on what walking strategies to use to increase hip extension angle, to not bias the results. If the participant surpasses the target hip extension angle, the target will blink green, indicating a successful trial. The target hip extension angle is the average of the four greatest peak hip extension angles the individual has achieves within the current training bout. Once the participant exceeds the current target angle, a new target will be created at the new average value. This novel feedback paradigm encourages the individual to progressively increase their peak hip extension by providing a high, but previously achieved target goal that adapts to improved performance in real-time. During training bouts, research personnel will follow the participant for safety. Clinical Assessment: Participants will complete a clinical assessment prior to biomechanical assessments and training. Measurements from this assessment will include hip flexion and extension range of motion, hip flexion and extension strength, plantarflexion strength, and spasticity and will be used as covariates in analysis if significant effects are demonstrated within a factor. Hip flexion and extension range of motion will be measured with a goniometer while the participant is positioned on a patient table supine for flexion and prone for extension. Research personnel will guide the limb being measured to end range of motion while also bracing the pelvis to prevent extra motion not coming from the hip. Hip flexion and extension and plantarflexion strength will be measured using an isokinetic dynamometer (Biodex Medical Systems) where participants will complete three maximal voluntary contractions in each direction for each limb with the maximum torque being recorded and used for analysis. Spasticity will be assessed by asking participants to rate the frequency of their spasms on a 5-point scale ranging from no spasms to spasms occurring more than 10 times per hour, then severity of spasms will be assessed by a researcher using a 3-point scale ranging from mild to severe. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05420857
Study type Interventional
Source University of Nebraska
Status Not yet recruiting
Phase N/A
Start date July 1, 2022
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Suspended NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Recruiting NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT04399759 - Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke N/A
Completed NCT03698357 - Video Balance-based Exercise in Persons With Stroke N/A
Completed NCT04069039 - Is There a Relationship Between the Ability of the Trunk and Lower Extremities and Walking Function After Stroke?
Completed NCT03578536 - Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT03402906 - Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke N/A
Completed NCT02907775 - Multi-channel Stimulation for Post Stroke Spasticity (MUSTS) N/A