Investigación local. Conexiones humanas. WCR Miami Lakes (786) 483-7856
Volver a buscar estudiosNCT07928050
CompletadoNCT07928050Registro de ClinicalTrials.gov

RehaBEElitation - Serious Game-Based Experimental Protocol to Improve Manual Dexterity in Individuals With Parkinson's Disease

Parkinson Disease

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
40 años - 100 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
27 Real

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

This is a non-randomized controlled trial with two parallel groups, with the general objective of developing and applying an assessment and intervention protocol based on a serious game for the rehabilitation of hand function in individuals with Parkinson's disease (PD). The experimental group trained with the RehaBEElitation serious game, controlled by hand and wrist movements through a wearable sensor glove; the control group trained the same five movements with a home exercise booklet. Both groups trained twice a week for six weeks (12 sessions of 30 to 45 minutes) and kept their usual physiotherapy. Participants were allocated in sequence: those enrolled first received the serious game and those enrolled later received the booklet. Manual dexterity, motor signs, quality of life, functioning and upper-limb muscle activation (surface electromyography) were assessed before and after the intervention. This trial was registered retrospectively.

¿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:

  • Diagnosis of Parkinson's disease confirmed by a neurologist or geriatrician
  • Age between 40 and 100 years
  • Mild to moderate disease (Hoehn \& Yahr stages I to III)
  • Mini-Mental State Examination score above 25
  • No severe visual (Snellen chart) or hearing impairment
  • No other neurological or musculoskeletal disease
  • Functional and body-structure requirements for the training, assessed with the ICF checklist
  • Read and agreed to the informed consent form

Exclusion Criteria:

  • Uncontrolled hypertension, unstable angina or recent myocardial infarction
  • History of seizures
  • Participation in another clinical trial involving rehabilitation or an experimental drug
  • Missing more than three sessions or withdrawing from the intervention
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
Sin asignación al azar
Enmascaramiento
Sin enmascaramiento
RehaBEElitation serious game

Group of subjects with Parkinson's disease trained with the RehaBEElitation serious game, twice a week for six weeks (12 sessions of 30 to 45 minutes), in addition to usual physiotherapy.

Device: RehaBEElitation serious game

Home exercise booklet

Group of subjects with Parkinson's disease trained with a home exercise booklet with the same five movements, twice a week for six weeks (12 sessions of 30 to 45 minutes), with remote follow-up, in addition to usual physiotherapy.

Behavioral: Home exercise booklet

RehaBEElitation serious game DEVICE

3D serious game controlled by hand and wrist movements (open/close the hand, pinch grip, wrist flexion-extension and radial-ulnar deviation, forearm pronation-supination) through a wearable glove with inertial and force sensors and haptic feedback. Twice a week for six weeks (12 sessions of 30 to 45 minutes).

Home exercise booklet BEHAVIORAL

Printed booklet with the same five hand and wrist movements, performed in two sets of 2 minutes with 1 minute of rest, twice a week for six weeks (12 sessions of 30 to 45 minutes), with remote follow-up.

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Box and Block Test

Plazo: Baseline and 6 weeks

Number of blocks transferred in 60 seconds with the most affected hand. Higher scores mean a better outcome.

Nine-Hole Peg Test

Plazo: Baseline and 6 weeks

Time in seconds to place and remove nine pegs. Higher values mean a worse outcome.

MDS-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)

Plazo: Baseline and 6 weeks

Clinical scale of motor signs. Each item is rated from 0 (normal) to 4 (severe); higher scores mean a worse outcome.

Parkinson's Disease Questionnaire (PDQ-39)

Plazo: Baseline and 6 weeks

Disease-specific quality of life. Summary index from 0 to 100; higher scores mean a worse outcome.

International Classification of Functioning, Disability and Health (ICF) checklist

Plazo: Baseline and 6 weeks

Activity and participation components; functioning and disability in daily life.

Muscle activation of the flexor carpi radialis (surface electromyography)

Plazo: Baseline and 6 weeks

EMG of the flexor carpi radialis, normalised to the maximal voluntary contraction (%MVC), averaged across the reaching task, the Box and Block Test, the Nine-Hole Peg Test and the Trail Making Test.

Muscle activation of the extensor carpi ulnaris (surface electromyography)

Plazo: Baseline and 6 weeks

EMG of the extensor carpi ulnaris, normalised to the maximal voluntary contraction (%MVC), averaged across the reaching task, the Box and Block Test, the Nine-Hole Peg Test and the Trail Making Test.

Muscle activation of the biceps brachii (surface electromyography)

Plazo: Baseline and 6 weeks

EMG of the biceps brachii, normalised to the maximal voluntary contraction (%MVC), averaged across the reaching task, the Box and Block Test, the Nine-Hole Peg Test and the Trail Making Test.

Muscle activation of the triceps brachii (surface electromyography)

Plazo: Baseline and 6 weeks

EMG of the triceps brachii, normalised to the maximal voluntary contraction (%MVC), averaged across the reaching task, the Box and Block Test, the Nine-Hole Peg Test and the Trail Making Test.

Muscle activation of the anterior deltoid (surface electromyography)

Plazo: Baseline and 6 weeks

EMG of the anterior deltoid, normalised to the maximal voluntary contraction (%MVC), averaged across the reaching task, the Box and Block Test, the Nine-Hole Peg Test and the Trail Making Test.

Trail Making Test part A

Plazo: Baseline and 6 weeks

Time in seconds to complete part A. Higher values mean a worse outcome.

Trail Making Test part B

Plazo: Baseline and 6 weeks

Time in seconds to complete part B. Higher values mean a worse outcome.

Handwriting movement analysis

Plazo: Baseline and 6 weeks

Spiral and sinusoid drawings (10 copies of each).

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

Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology Assessment in HealthUberlândia, Minas Gerais, BrazilEstado desconocido

Equipo y fechas

Patrocinador principal
Federal University of Uberlandia
Inicio del estudio
24 oct 2023 Real
Finalización primaria
5 nov 2024 Real
Finalización del estudio
5 nov 2024 Real
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

RehaBEElitation - Serious Game-Based Experimental Protocol to Improve Manual Dexterity in Individuals With Parkinson's Disease

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.

No incluyas expedientes médicos, diagnósticos, medicamentos, números de seguro ni otros datos sensibles. Este formulario es para preguntas generales, no para atención urgente.

Enviar una pregunta no te inscribe en un estudio.

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