Spinal Networks of Balance Learning and Retention in Older Adults
NCT Number: NCT06517043
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging
Interventions: BEHAVIORAL: Balance Training|DEVICE: Spinal Active tsDCS|DEVICE: Spinal Sham tsDCS
Sponsor: University of Florida
Sex: ALL
Age: OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31

Summary:
Age-related balance and walking issues increase fall risks, leading to injuries, higher healthcare costs, reduced quality of life, and increased morbidity/mortality rates. Preserving functional ability is a crucial public health priority, with the potential to reduce healthcare costs and enhance older adults' quality of life. Declines in balance and walking ability threaten independence. These declines are attributed to spinal network impairments and may be mitigated by targeted interventions aimed at addressing age-related spinal cord impairment to enhance functional outcomes. However, there is a lack of research into how the aging spinal cord affects balance/walking. In older adults, the spinal cord is less excitable, conducts signals more slowly, and is subject to neural noise. Intervening on age-related impairment of the spinal cord to improve balance/walking ability is a very promising but untapped area of research. A therapeutic approach that combines dynamic balance training with non-invasive electrical spinal stimulation may be effective in preserving functional abilities. This study tests whether electrical stimulation of the spinal lumbar regions is more beneficial than sham stimulation.

Primary Outcome Measures: Center of Pressure (COP) balance control, Change in the center of pressure during static and dynamic postural control on a Dividat Senso pressure-sensitive plate will be assessed from baseline to post-intervention and follow-up., Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)|Walking speed over obstacle course, Change in fastest walking speed over a 10-meter obstacle course on the GAITRite system will be assessed from baseline to post-intervention and follow-up., Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)|Spinal excitability via Soleus H-reflex testing, Change in spinal excitability, measured via the soleus H-reflex testing using electromyography, will be assessed before and immediately following active or sham tsDCS (combined with balance training) during the 1st and 5th of the total five intervention sessions. The magnitude of change will be compared between these sessions., Baseline and immediately following 30-minute intervention
Secondary Outcome Measures: Score on standardized balance assessment (Berg Balance Scale), Change in balance scores will be assessed using the Berg Balance Scale from baseline to post-intervention and follow-up. The scale ranges from 0 to 56, with higher scores indicating better balance performance., Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)|Score on standardized walking assessment (Functional Gait Assessment), Change in walking scores will be assessed using the Functional Gait Assessment from baseline to post-intervention and follow-up. The scale ranges from 0 to 30, with higher scores indicating better walking performance., Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)|Completion time on test of executive function (Trail Making Test), Change in completion time from baseline to post-intervention and follow-up will be assessed using the Trail Making Test. Shorter times indicate better cognitive performance., Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)|tsDCS treatment-related adverse events as assessed by a survey questionnaire., Change in the score of side effects from tsDCS (e.g., sensations of burning, tingling, itching, and pain) will be assessed before and following active or sham tsDCS (combined with balance training) for every 30-minute intervention session using a survey questionnaire. Each question on the scale ranges from 0 to 10, and the scores will be averaged. A higher mean score indicates a higher severity of side effects., Baseline and following 30-minute intervention|Prefrontal cortical activity using fNIRS, Change in prefrontal brain activity during static and dynamic balance control and fastest walking assessments will be assessed using functional Near-Infrared Spectroscopy (fNIRS) from baseline to post-intervention and follow-up., Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)