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A Manualized Recreational Therapy Balance Program for Older Adults With Parkinson's and Movement Disorders

22 de septiembre de 2026 actualizado por: JungyuLee, Oklahoma State University

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

24

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Oklahoma
      • Stillwater, Oklahoma, Estados Unidos, 74074
        • Legacy Village of Stillwater
        • Contacto:
          • Lindsey Lovekamp
          • Número de teléfono: 405-714-6053
          • Correo electrónico: LindseyL@wslm.biz

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in gait velocity measured by the GAITRite system
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in postural stability measured by the BioSway system
Periodo de tiempo: 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
Change in fall-related self-efficacy measured by the Short Falls Efficacy Scale-International (Short FES-I)
Periodo de tiempo: 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
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline, 12 weeks, 24 weeks

Scale measuring perceived social network size and support. Higher scores indicate greater social connectedness.

Baseline, 12 weeks, 24 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

13 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

22 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de septiembre de 2026

Publicado por primera vez (Actual)

29 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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