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Sieci rdzeniowe uczenia się i utrzymywania równowagi u osób starszych

10 listopada 2026 zaktualizowane przez: University of Florida

Regulacja obwodów kręgosłupa w celu poprawy równowagi i chodzenia oraz zwiększenia pobudliwości kręgosłupa u osób starszych

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.

Przegląd badań

Szczegółowy opis

A high proportion of older adults are currently or soon will be at risk for the well-known decline in walking and balance abilities that occur with aging. Preserving those abilities has become a major public health priority. Balance training can enhance functional abilities or attenuate functional decline; however, age-related motor deficits may impair practice-based motor learning and behavioral performance. Due to the crucial roles of the spinal cord in balance and walking performance, it is important to consider that age-related neural impairment of the spinal cord is a likely contributing factor. Specifically, the spinal cord in older adults has fewer neurons, is less excitable, and conducts signals more slowly.

Despite ample evidence of impaired spinal cord neuronal structure and function with aging, the potential benefit of an intervention targeting spinal control of balance and walking control has been largely unexplored. This dearth of research may be due in part to the lack of a clinically feasible intervention. However, the recent emergence of transcutaneous spinal direct current stimulation (tsDCS) as a non-invasive intervention creates new opportunities for understanding spinal cord contributions to balance and walking performance. Notably, our previous study was the first demonstration of the safety and feasibility of a lab-based intervention that combined tsDCS with complex walking practice. These initial findings support the enhanced efficacy of locomotor learning during a single session when combined with tsDCS in older adults. Building on the success of this preliminary data, the investigators now propose an extended, multisession intervention that combines tsDCS with balance training. The proposed study will be among the first multi-session trial to investigate the effects of tsDCS as an adjunct therapy to dynamic balance training in older adults.

This study aims to enroll 30 older adults aged 65 years or older with balance or walking deficits, determined through objective assessments. All participants will undergo the same five-session balance training over a 2-week period, which will emphasize the use of a unique balance exergaming device called the Dividat Senso. Participants will be randomly assigned to a tsDCS adjuvant group. The "Active group" will receive 30 continuous minutes of 2.5-mA tsDCS over lumbar regions T11/T12. The "Sham group" will receive the sham protocol, which involves an identical montage and stimulation arrangement but delivers no current for 27 minutes. Each 30-minutes session will be preceded and followed by balance and walking assessments to examine the intervention's effects over time. Spinal excitability, measured via soleus H-reflex testing, will be assessed immediately before and after tsDCS at the first and last intervention. Behavioral assessments will occur at baseline, 1 day post-intervention, and 10-day post-intervention to investigate pre vs. post effects and retention intervention effects. Prefrontal activity will be measured using functional near-infrared spectroscopy (fNIRS) during the behavioral assessments to evaluate demand on executive control networks.

The objective of using tsDCS is to upregulate spinal circuits to make them more responsive to task-specific activation, thereby fostering more robust learning and consolidation to enhance performance in dynamic balance tasks. Thus, the overarching hypothesis of the proposed research is that tsDCS will be a potent adjuvant therapy to a dynamic balance intervention by reinforcing task-appropriate spinal excitation to promote skill acquisition and retention, thereby improving balance and walking. This study will focus on achieving the following specific aims:

Specific Aim 1: Acquire preliminary effect size and response variance data to assess whether active adjuvant tsDCS therapy combined with dynamic balance training enhances practice-related gains in balance and walking performance and retention over time.

Specific Aim 2: Establish evidence of increased spinal excitability following tsDCS, positively correlating with gains in balance and walking functions.

The long term deliverable of this line of research will be a clinically feasible multi-modal intervention to assist in preserving motor function and independence in older adults. The knowledge and experience gained from this study will enable us to conduct larger studies to better understand the effects of aging on the spinal cord and to test rehabilitation interventions to promote healthy aging among older adults.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Florida
      • Gainesville, Florida, Stany Zjednoczone, 32608
        • Rekrutacyjny
        • Malcom Randall VA Medical Center Brain Rehabilitation Research Center
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

65 lat do 95 lat (Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • age range: 65 to 95 years
  • no severe high blood pressure: Resting systolic < 180 mmHg and diastolic < 100 mmHg
  • no severe vision impairment: Visual acuity ≥ 20/70 as determined by Snellen eye chart
  • walking problem: Preferred walking speed slower than 1.0 m/s over 10 meters
  • balance problem: Berg Balance Scale score < 45
  • no cognitive impairment: Montreal Cognitive Assessment (MoCA) score ≥ 26 out of 30

Exclusion Criteria:

  • diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
  • severe arthritis, such as awaiting joint replacement
  • current cardiovascular, lung or renal disease; untreated diabetes; terminal illness
  • myocardial infarction or major heart surgery in the previous year
  • cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
  • current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  • currently taking medications that affect the central nervous system, such as benzodiazepines, anti-cholinergic medication, and GABAergic medication, among others
  • uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
  • bone fracture or joint replacement in the previous six months
  • current enrollment in any other clinical trial
  • planning to relocate out of the area during the study period
  • non-English* speaking, due to the likelihood of difficulties following instructions and communicating remotely
  • clinical judgment of the investigative team

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Active tsDCS treatment

Participants will receive 30 minutes of continuous 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.

Complex balance task involving static and dynamic weight shifting and coordinated stepping

Active tsDCS over lumbar regions

Pozorny komparator: Sham tsDCS control

Participants will receive 3 minutes of 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.

Complex balance task involving static and dynamic weight shifting and coordinated stepping

Sham tsDCS over lumbar regions

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Center of Pressure (COP) balance control
Ramy czasowe: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

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
Ramy czasowe: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

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
Ramy czasowe: Baseline and immediately following 30-minute intervention

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Score on standardized balance assessment (Berg Balance Scale)
Ramy czasowe: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

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)
Ramy czasowe: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

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)
Ramy czasowe: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

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.
Ramy czasowe: Baseline and following 30-minute intervention

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
Ramy czasowe: Baseline, 1-day post-intervention (after intervention), 10-day follow-up (after post-intervention)

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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 stycznia 2025

Zakończenie podstawowe (Szacowany)

31 marca 2027

Ukończenie studiów (Szacowany)

30 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

8 lipca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 lipca 2024

Pierwszy wysłany (Rzeczywisty)

24 lipca 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • IRB202400382
  • R21AG084944 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

A Limited Dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Ramy czasowe udostępniania IPD

The Limited Dataset will be completed after the study is completed and primary/secondary data accepted for publication.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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