Walking and Balance Post-TBI
IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29208
- 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- greater than 3 months post-TBI (as defined by INTRuST criteria) and no longer receiving care as an inpatient in a rehabilitation facility.
- the ability to follow simple three-step commands;
- the ability to communicate presence and location of pain;
- the ability to sit independently without back or arm support for five minutes;
- the ability to stand with support of a straight cane, quad cane, or walker for 2 minutes;
- the ability to walk 10 meters with maximum 1 person assisting;
- presence of motor deficits (determined by clinical assessment of paresis);
- age ≥ 18;
- ability to give consent or have a acceptable surrogate capable of giving consent on subject's behalf
Exclusion Criteria:
- unable to ambulate 500 feet prior to TBI;
- history of serious chronic obstructive pulmonary disease or oxygen dependence;
- severe weight bearing pain;
- lower-extremity amputation;
- non-healing ulcers on the lower-extremity;
- renal dialysis or end stage liver disease;
- legal blindness or severe visual impairment;
- severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°);
- history of deep venous thrombosis or pulmonary embolism within 6 months
- uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
- severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest;
- intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded);
- history of severe uncontrolled seizure disorder;
- other neurological conditions such as multiple sclerosis or Parkinson's Disease;
- pain that is scored greater than 5 out of 10 on a visual analog scale;
- any factor contraindicative to MRI examination (e.g., cardiac pacemaker/ defibrillator, pregnancy, aneurysm clips, insulin pump, metal fragments in the body).
- any other health problems judged by their screening physician to put the client at significant risk of harm during the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Intensive Mobility Training (IMT)
Intensive Mobility Training will be used as an intensive physical therapy intervention.
Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.
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Intensive Mobility Training will be used as an intensive physical therapy intervention.
Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility as measured by study completion.
Periodo de tiempo: post-treatment (after 20-day intervention)
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Feasibility will be determined by the ratio of participants that complete the intervention.
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post-treatment (after 20-day intervention)
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Feasibility as measured by pain ratings.
Periodo de tiempo: during 20-day intervention
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Feasibility will be determined by daily change in pain scores as measured using visual analog scales.
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during 20-day intervention
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Feasibility as measured by fatigue ratings.
Periodo de tiempo: during 20-day intervention
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Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.
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during 20-day intervention
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Efficacy as measured by improvements in gait and mobility.
Periodo de tiempo: from pre- to post-treatment during 20-day intervention.
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Efficacy will be measured by improvements in mobility and gait as measured by the Dynamic Gait Index, Timed Up and Go, Six- Minute Walk, and Falls Efficacy Scale.
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from pre- to post-treatment during 20-day intervention.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Stacy Fritz, Ph.D., P.T., University of South Carolina
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- INTRuST-Walking and Balance
- Pro00007596 (Otro identificador: University of South Carolina IRB)
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