Comparison of Three Balance Training Protocols for Individuals Post Stroke

Status unconfirmed · Not applicable

Conditions studied: Fall, Risk Reduction, Stroke, Balance

In brief

The purpose of this study is to compare conventional balance training to reactive training and to a novel, high intensity, harnessed training program. This study examines the impact of these interventions on fall risk and on a range of important aspects of balance including overall mobility, quality of life, and health. Participants will be 60-69 adults who had a stroke more than 6 months ago and who ambulate independently. Each participant will complete 14 sessions consisting of 4 (2 pre-, 2 post-) testing sessions and 10 intervention sessions. The pre and post testing will be the same and will consist of clinical and survey based balance and quality of life assessments and treadmill based perturbed gait testing. The pretest will be sessions 1 and 2 will be followed by 10 intervention sessions. There will be 3 treatment groups: a conventional balance training group (PT), a reactive slip training group (Slip), and a multidirectional harness group (MHG). Participants will be randomly assigned to a group following screening and consent. The conventional balance training group (PT) will receive 10 sessions of individualized standard of care physical therapy with the goal of improving balance and mobility. The only instructions to the PT are that the focus of the course of care should be on "balance and mobility" and that there should be 10 sessions. The reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. The remaining nine intervention sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher. The multidirectional harness group (MHG) will use a harness that allows movement in all directions, playing selected Kinect™ active video games with varied balance demands, on multiple balance training surfaces (e.g., rocker board, foam, slider platform). Participants will wear the fall-arresting harness for all game play. Motion data will be collected during Sessions 2, 6, and 10. For all groups, two-post-test sessions will follow the intervention sessions and will be the same as the two-pretest session. The final session will also include reviewing the participants' falls diaries and setting up procedures for contacting participants weekly or biweekly about falls.

Key facts

Study ID

NCT03757026

Run by

Cleveland State University

People needed

66

Starts

2018-12-12

Expected to finish

2021-03-01

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stroke more than 6 months ago
• Self-identified balance issues
• Independent ambulation - specifically:
• Walk at least one-half block (150') with or without standard cane or similar device
• Stand independently for at least 30 seconds without physical assistance and without any device
• At least ten steps without physical assistance and without any cane or similar device
• Ability to answer two-step questions

You may not qualify if…

• Allergic reaction to adhesive tapes
• Height above 74"
• Weight above 250 lbs
• Medical Condition - they are not eligible if they self-identify as having any musculoskeletal, neuromuscular, cardiopulmonary, or other conditions that would limit them from participation.

Where it is running

• Cleveland State University — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.