- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04142853
Underlying Causes and Related Factors, and Rehabilitation Approaches
Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Hasselt, Bélgica, 3500
- Hasselt University
-
Liège, Bélgica, 4000
- Centre Hospitalier Universitaire de Liège
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age between 18 and 70 years.
- MS diagnosis according to McDonald Criteria.
- Capable of walking 6 minutes (independent or with unilateral support) without stopping.
Exclusion Criteria:
- Exacerbation or relapse within last 3 months before study
- Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Persons with MS, dance group
|
Training intervention + Dance intervention
|
Comparador activo: Persons with MS, art group
|
Training intervention + Dance intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
la prueba de modalidad de dígitos de símbolo (SDMT) (fatigabilidad cognitiva)
Periodo de tiempo: semana 11
|
Esta es una prueba de desempeño cognitivo, corroborada con enfoque, velocidad y exploración visual.
Respuestas correctas últimos 30 segundos vs primeros 30 segundos
|
semana 11
|
Prueba de clavija de nueve orificios (NHPT)
Periodo de tiempo: semana 11
|
Se trata de una prueba motora para evaluar las habilidades manuales del participante.
Esta prueba registra el tiempo que necesita el participante para colocar 9 pines en el tablero y quitarlos nuevamente.
|
semana 11
|
the Coordination test
Periodo de tiempo: Day 1
|
Participant is seated with legs strapped in to the mounts and moves legs to the beat of a metronome to assess central motor control.
|
Day 1
|
TST (Triple Stimulation Technique)
Periodo de tiempo: day 3
|
Technique in which nerves are stimulated to check guidance in the central nervous system
|
day 3
|
TMS (Transcranial Magnetic Stimulation)
Periodo de tiempo: Day 3
|
Technique in which nerves are stimulated to check guidance in the central nervous system
|
Day 3
|
the Voluntary Drive test
Periodo de tiempo: Day 1
|
The participant is seated in a Biodex.
While performing a leg extension the Quadriceps muscle is stimulated to check the guidance of electrical signals to the muscles.
|
Day 1
|
the Fatigability Index Legs
Periodo de tiempo: Day 1
|
Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.
|
Day 1
|
Analysis of a Muscle Biopsy
Periodo de tiempo: Day 3
|
A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.
|
Day 3
|
the Digit Span
Periodo de tiempo: Baseline
|
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
|
Baseline
|
the Digit Span
Periodo de tiempo: Week 11
|
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
|
Week 11
|
the Stroop test
Periodo de tiempo: Baseline
|
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
|
Baseline
|
the Stroop test
Periodo de tiempo: week 11
|
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
|
week 11
|
the Paced Auditory Serial Addition Test (PASAT)
Periodo de tiempo: Baseline
|
This is a cognitive test where the participant will try to retain certain numbers they hear and do math.
Correct answer last 1/3 vs first 1/3
|
Baseline
|
the Paced Auditory Serial Addition Test (PASAT)
Periodo de tiempo: Week 11
|
This is a cognitive test where the participant will try to retain certain numbers they hear and do math.
Correct answer last 1/3 vs first 1/3
|
Week 11
|
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Periodo de tiempo: Baseline
|
his is a cognitive performance test, substantiated with focus, speed, and visual scanning.
Correct answers last 30 seconds vs first 30 seconds
|
Baseline
|
Motor function test (lower limb muscle strength)
Periodo de tiempo: Baseline
|
This is a motor test to assess the functional lower limb muscle strength.
The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
|
Baseline
|
Motor function test (lower limb muscle strength)
Periodo de tiempo: week 11
|
This is a motor test to assess the functional lower limb muscle strength.
The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
|
week 11
|
25 Foot Walk (T25FW) test
Periodo de tiempo: Baseline
|
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible.
This is a quantitative performance test to assess mobility and leg function.
|
Baseline
|
25 Foot Walk (T25FW) test
Periodo de tiempo: week 11
|
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible.
This is a quantitative performance test to assess mobility and leg function.
|
week 11
|
Nine Hole Peg Test (NHPT)
Periodo de tiempo: Baseline
|
This is a motor test to assess the participant's manual skills.
This test records the time the participant needs to place 9 pins in the pegboard and remove them again.
|
Baseline
|
Fatigability Index Hand
Periodo de tiempo: Baseline
|
Grip strength will be evaluated through a Jamar dynamometer.
|
Baseline
|
Fatigability Index Hand
Periodo de tiempo: week 11
|
Grip strength will be evaluated through a Jamar dynamometer.
|
week 11
|
Activity tracker
Periodo de tiempo: Up to 5 days
|
A sensor will be placed around the foot and worn by the participant for 5 days and nights to evaluate physical activity and quality of sleep.
|
Up to 5 days
|
Glycocheck
Periodo de tiempo: Baseline
|
A small camera will be placed under the tongue of the participant and blood vessels will be filmed to determine the quality of the blood vessels and immunity.
|
Baseline
|
Six minute walking test
Periodo de tiempo: once during the observational study
|
Participant have to walk as far as they can for 6 minutes.
Total distance walked and fatigability by comparing first and last minute distance will be calculated.
|
once during the observational study
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fatigue severity scale (FSS)
Periodo de tiempo: baseline
|
A self-report scale of nine items about fatigue, its severity and how it affects certain activities.
Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree.
This means the minimum score possible is nine and the highest is 63.
The higher the score, the more severe the fatigue is and the more it affects the person's activities.
It is simple to understand and takes an average of eight minutes to answer
|
baseline
|
Fatigue severity scale (FSS)
Periodo de tiempo: week 11
|
A self-report scale of nine items about fatigue, its severity and how it affects certain activities.
Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree.
This means the minimum score possible is nine and the highest is 63.
The higher the score, the more severe the fatigue is and the more it affects the person's activities.
It is simple to understand and takes an average of eight minutes to answer
|
week 11
|
Modified Fatigue Impact Scale (MFIS)
Periodo de tiempo: baseline
|
This is a short questionnaire to evaluate to impact of general fatigue.
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial.
The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
|
baseline
|
Modified Fatigue Impact Scale (MFIS)
Periodo de tiempo: week 11
|
This is a short questionnaire to evaluate to impact of general fatigue.
This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial.The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
|
week 11
|
Fatigue Scale of Motor and Cognitive Functions (FSMC)
Periodo de tiempo: baseline
|
This is a short questionnaire to cognitive and motor fatigue in people with MS.
The FSMC is an assessment of MS-related cognitive and motor fatigue.
A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question.
Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
Two subscales (mental and physical fatigue) can be made.
Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
|
baseline
|
Fatigue Scale of Motor and Cognitive Functions (FSMC)
Periodo de tiempo: week 11
|
This is a short questionnaire to cognitive and motor fatigue in people with MS.
The FSMC is an assessment of MS-related cognitive and motor fatigue.
A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question.
Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
Two subscales (mental and physical fatigue) can be made.
Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
|
week 11
|
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: baseline
|
This is a short questionnaire that evaluates symptoms of anxiety and depression in daily life.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression..
|
baseline
|
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: Week 11
|
This is a short questionnaire that evaluates symptoms of anxiety and depression in daily life.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
|
Week 11
|
The Sleep Condition Indicator (SCI)
Periodo de tiempo: baseline
|
This is a short questionnaire to evaluate sleeping pattern and potential sleeping disorders.
The Sleep Condition Indicator (SCI) is an eight-item rating scale (4-0) that was developed to screen for insomnia disorder based on DSM-5 criteria.
|
baseline
|
The Sleep Condition Indicator (SCI)
Periodo de tiempo: week 11
|
This is a short questionnaire to evaluate sleeping pattern and potential sleeping disorders.
The Sleep Condition Indicator (SCI) is an eight-item rating scale (4-0) that was developed to screen for insomnia disorder based on DSM-5 criteria.
|
week 11
|
Social Role Participation Questionnaire (SRPQ)
Periodo de tiempo: baseline
|
This is a short questionnaire to evaluate social participation.
scale 1 (not important) - 5(very important)
|
baseline
|
Social Role Participation Questionnaire (SRPQ)
Periodo de tiempo: week 11
|
This is a short questionnaire to evaluate social participation.
scale 1 (not important) - 5 (very important)
|
week 11
|
pre-interventionMSWS-12 score
Periodo de tiempo: baseline
|
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
baseline
|
post-interventionMSWS-12 score
Periodo de tiempo: baseline
|
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
baseline
|
pre-interventionMSWS-12 score
Periodo de tiempo: week 11
|
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
week 11
|
post-interventionMSWS-12 score
Periodo de tiempo: week 11
|
short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores. |
week 11
|
Multiple Sclerosis Impact Scale (MSIS-29)
Periodo de tiempo: Baseline
|
This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100 |
Baseline
|
Multiple Sclerosis Impact Scale (MSIS-29)
Periodo de tiempo: week 11
|
This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health). The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100 |
week 11
|
Short Form Health survey (SF-36)
Periodo de tiempo: Baseline
|
questionnaire to measure health status.
The Optum® SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view.
It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes.
|
Baseline
|
Short Form Health survey (SF-36)
Periodo de tiempo: week 11
|
questionnaire to measure health status.
The Optum® SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view.
It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes.
|
week 11
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B707201835771
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
Ensayos clínicos sobre Training intervention + Dance intervention
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
-
Shiraz University of Medical SciencesTerminado
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
-
The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
-
VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
-
Sahlgrenska University Hospital, SwedenKarolinska University Hospital; Skane University Hospital; Karlstad Central Hospital y otros colaboradoresActivo, no reclutandoClaudicación intermitenteSuecia