- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07845474
A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders
Enhancing Stability and Connection: A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders in Oklahoma Small Cities
This study evaluates a manualized recreational therapy balance program for older adults with Parkinson's disease and movement disorders who live in small cities and rural areas of Oklahoma, where access to movement disorder specialists is limited.
Twenty-four older adults with Parkinson's disease and movement disorders will be randomly assigned to one of two groups of 12. One group will attend the balance program continuously for 24 weeks. The other group will attend the program for 12 weeks and will then be observed for 12 weeks without the program. All sessions are led by a Certified Therapeutic Recreation Specialist and last about 50 minutes once a week.
Participants will be assessed three times: before the program begins, at three months, and at six months. The assessments measure gait velocity and stride length, postural stability, fall-related confidence, anxiety and depression, and social connectedness.
The purpose of the study is to learn how long a community balance program needs to continue for older adults to keep the gains they make, and how quickly those gains decline when the program ends.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Parkinson's disease and movement disorders accelerate physical decline. In Oklahoma, more than 15,000 residents have Parkinson's disease, and about one-third live in rural areas. Rural isolation restricts access to movement disorder specialists, and fewer than 30% of individuals with Parkinson's disease engage in regular physical activity. Rural patients face barriers including limited transportation, fear of injury, and a lack of local programs or peer support.
This study evaluates a manualized recreational therapy balance protocol that was developed with funding from the American Parkinson Disease Association (FY2025-1461556). The evaluation is designed to determine the dosage of community-based exercise required to promote sustained mobility and to prevent the physical regression often seen after a program ends.
Design. Twenty-four older adults diagnosed with Parkinson's disease and movement disorders will be randomly assigned to two equal cohorts of 12 in a two-cohort comparative evaluation. Cohort 1 will receive the continuous in-person intervention for six months (24 weeks). Cohort 2 will receive the intervention for three months (12 weeks), followed by a three-month observation period intended to quantify the decay of training effects.
Setting. The intervention is delivered in person at Legacy Village of Stillwater, Oklahoma.
Participants. Participants must be able to tolerate a 50-minute physical session once per week.
Intervention. All sessions follow a manualized recreational therapy balance protocol and are directed by a Certified Therapeutic Recreation Specialist. The program includes static and dynamic balance training.
Assessments. Data are collected by a Certified Therapeutic Recreation Specialist and research assistants at baseline, month three, and month six. The GAITRite system (CIR Systems, New Jersey, USA) measures gait velocity and stride length. The BioSway system (Biodex Medical Systems, New York, USA) quantifies postural stability. Secondary outcomes are measured with the Short Falls Efficacy Scale-International for fall-related self-efficacy, the Hospital Anxiety and Depression Scale for psychological states, and the Lubben Social Network Scale for social connectedness.
Research questions. (1) Does a 24-week continuous manualized recreational therapy balance program yield higher retention of postural stability and gait velocity compared with a 12-week intervention followed by a 12-week observation period in adults with Parkinson's disease? (2) How do the two intervention durations differ in sustaining fall-related self-efficacy, reducing anxiety, and building social connectedness at the six-month benchmark? (3) What duration of CTRS-led community intervention establishes lasting independence for patients lacking access to movement disorder specialists?
Hypotheses. (1) The 24-week cohort retains baseline posture and gait velocity at month six, while the 12-week cohort experiences regression. (2) The 24-week cohort sustains fall confidence, reduces anxiety, and builds group bonds at month six. (3) The 24-week duration establishes the threshold for lasting patient independence.
Analysis. Analysis is conducted in collaboration with the Oklahoma State University Physical Activity and Public Health Lab using a two-way repeated-measures analysis of variance across three time points (baseline, week 12, and week 24), comparing the continuous cohort with the abbreviated cohort.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jungyu Lee, PhD
- Numer telefonu: 405-762-1844
- E-mail: jungyu.lee@okstate.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Tim Passmore, Ed.D.
- Numer telefonu: 405-744-1811
- E-mail: tim.passmore@okstate.edu
Lokalizacje studiów
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Oklahoma
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Stillwater, Oklahoma, Stany Zjednoczone, 74074
- Legacy Village of Stillwater
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Kontakt:
- Lindsey Lovekamp
- Numer telefonu: 405-714-6053
- E-mail: LindseyL@wslm.biz
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Diagnosis of Parkinson's disease or another movement disorder
- Able to tolerate a 50-minute physical activity session once per week
- Able to attend in-person sessions at the study site
- Willing and able to provide informed consent
Exclusion Criteria:
- Medical condition that prevents safe participation in balance exercise
- Unable to attend the weekly in-person sessions
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 24-week continuous balance program
Participants attend the manualized recreational therapy balance program continuously for 24 weeks. Sessions are led by a Certified Therapeutic Recreation Specialist, last approximately 50 minutes, and are held once per week at Legacy Village of Stillwater. Sessions include static and dynamic balance training. Assessments are conducted at baseline, month three, and month six. |
A manualized balance training protocol delivered in person by a Certified Therapeutic Recreation Specialist in approximately 50-minute weekly sessions, including static and dynamic balance training. The protocol was developed with funding from the American Parkinson Disease Association. |
|
Aktywny komparator: 12-week balance program followed by 12-week observation
Participants attend the same manualized recreational therapy balance program for 12 weeks under the same schedule and format, and then enter a 12-week observation period during which the program is not provided. Assessments are conducted at baseline, month three, and month six. |
A manualized balance training protocol delivered in person by a Certified Therapeutic Recreation Specialist in approximately 50-minute weekly sessions, including static and dynamic balance training. The protocol was developed with funding from the American Parkinson Disease Association. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in gait velocity measured by the GAITRite system
Ramy czasowe: Baseline, 12 weeks, 24 weeks
|
Gait velocity in centimeters per second measured with the GAITRite electronic walkway (CIR Systems, New Jersey, USA). Higher values indicate faster walking. |
Baseline, 12 weeks, 24 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in postural stability measured by the BioSway system
Ramy czasowe: Baseline, 12 weeks, 24 weeks
|
Postural stability measured with the BioSway balance system (Biodex Medical Systems, New York, USA). Higher sway values indicate poorer postural stability. |
Baseline, 12 weeks, 24 weeks
|
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Change in fall-related self-efficacy measured by the Short Falls Efficacy Scale-International (Short FES-I)
Ramy czasowe: Baseline, 12 weeks, 24 weeks
|
Seven-item scale scored from 7 to 28. Higher scores indicate greater concern about falling. |
Baseline, 12 weeks, 24 weeks
|
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Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Ramy czasowe: Baseline, 12 weeks, 24 weeks
|
Fourteen-item scale scored from 0 to 42. Higher scores indicate greater anxiety and depressive symptoms. |
Baseline, 12 weeks, 24 weeks
|
|
Change in social connectedness measured by the Lubben Social Network Scale (LSNS)
Ramy czasowe: Baseline, 12 weeks, 24 weeks
|
Scale measuring perceived social network size and support. Higher scores indicate greater social connectedness. |
Baseline, 12 weeks, 24 weeks
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-26-195
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data will not be shared publicly. The IRB-approved protocol and informed consent documents do not include provisions for sharing individual participant data outside the research team. De-identified aggregate results will be reported in peer-reviewed publications.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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