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ReclutandoNCT07621978Registro de ClinicalTrials.gov

Variable Intense Training for Ataxia and Locomotion

Cerebellar Disorders · Cerebellar Degeneration · Cerebellar Atrophy · Cerebellar Lesions

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - 85 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
20 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease

Leer la descripción completa

The goal of this study is to evaluate the feasibility and potential preliminary efficiency of high-intensity training focused on stepping in variable contexts as compared to conventional training in individuals with cerebellar disease

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Ages 18-85
  • \>6 months following brain injury or diagnosis of cerebellar dysfunction
  • A total score of \> 4 on items 5-8 on the SARA for the ipsilateral limb
  • Ability to ambulate 10 m at self-selected gait speeds (SSV) \<1.2 m/s with no greater than minimal physical assistance permitted for postural stability only, but with below knee bracing and/or assistive device as needed
  • Weight \< 350 pounds
  • Able to follow 1-step command
  • Medical clearance to participate

Exclusion Criteria:

  • Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
  • Currently participating in other physical therapy
  • \>50 units of Botox within the past three months in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis
  • Individuals deemed not stable between Pre-Baseline Testing and Baseline Testing
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
High-intensity training in variable contexts

High-intensity training focused on stepping tasks in variable contexts (tasks and environments) while targeting higher cardiovascular intensity (\>75% maximum predicted heart rates) during up to 40 mins of 1-hr sessions. A total of 20 sessions will be targeted.

Other: High-intensity training in variable contexts

Conventional balance training

Conventional balance activities will consist of sitting and standing balance exercises, with selected dynamic stability exercises performed during walking tasks. Heart rates will be monitored with no targeted range. All sessions will be 1-hr long with balance activities for up to 40 minutes per session. A total of 20 sessions will be targeted.

Other: Conventional balance training

High-intensity training in variable contexts OTHER

High intensity stepping training: Training sessions will focus on maximizing stepping activities in variable contexts while targeting ≥70% HR reserve (or approximately 80% age-predicted maximum HR) calculated using the Karvonen formula. Target HR will be decreased by 10 beats if the individual is on beta-blockers. Intensity will also be monitored using the Borg RPE scale every 3-5 minutes with goals of ≥15 on a 6-20 scale. The intensity of the walking training will be primarily modulated through the treadmill speed and incline as well as addition of weights to the torso or limbs for the purpose of error augmentation and not to dampen ataxia. Sessions will focus on achieving up to 40 minutes of stepping training within each 60-minute session. Potential tasks include walking in multiple directions, over inclines and obstacles, and/or with weighted vests and leg weights with limited handrail use as tolerated and decided by the therapist and participant.

Conventional balance training OTHER

Conventional training: Training sessions will focus on improving static and dynamic balance, while calculated using the Karvonen formula. Target HR ranges will be decreased by 10 beats if the individual is on beta-blockers. Intensity will also be monitored using heart rates and RPE every 3-5 minutes with goals of \<14 on a 6-20 scale. Sessions will focus on balance training for up to 40 minutes within a 60-minute session. Individuals will perform \~10 minutes (\~25% of sessions) on balance activities in the sitting position, \~20 minutes (50% of sessions) of standing positions and \~10 minutes (25% of sessions) of walking training.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

6-min walk test

Plazo: Changes from baseline to post-training following up to 20 sessions over approximately 8 weeks

Participants will walk for 6 minutes with instructions to "cover as much ground as they can".

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Rehabilitation Hospital of IndianaIndianapolis, Indiana, United StatesReclutando

Equipo y fechas

Patrocinador principal
Indiana University
Inicio del estudio
15 jun 2026 Real
Finalización primaria
15 jun 2028 Estimado
Finalización del estudio
15 dic 2028 Estimado
Primera publicación
2 jun 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Thomas G HornbyCONTACTtghornby@iu.edu3123508291
Christopher HendersonCONTACThenderce@iu.edu3173292353
Título oficial del estudio

Feasibility and Potential Efficacy of High-intensity Gait Training in Individuals With Cerebellar Damage

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026