- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04825405
The Use of the Tip Stim Glove Device to Achieve Coordinated Movement of the Human Hand
Influence of the Tested Position and the Use of the TipStim Glove Device on the Improvement of the Hand Motor Coordination After Stroke
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
To test the effectiveness of the Tip Stim device, each patient received (alternating) both the experimental and control treatments in a specific sequence to assess the coordination of human hand movement and the grip strength. The first therapy with the use of Tip Stim parameters (Ratio current time to pause time: 2 sec :5 sec; Ramp (rise time impulse): 0,3 sec; Frequency: 20 Hz; Pulse width: 300 µs). Another session (putting on the glove without setting any parameters) took place after a week (time to mute the effects of the intervention). The duration of each therapy session is 60 minutes. After the first therapeutic session and after a week, the parameters of movement coordination and hand grip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) (fig. 1) and lying (with stabilization) (fig. 2), and with a different position of the examined upper limb. During the first examination, the subject sat on a treatment table, feet resting on the floor. Upper limb examined in adduction, with bent elbow joint in the intermediate position between pronation and supination of the forearm. In the supine examination, the upper limb was stabilized against the subject's body (adduction in the shoulder joint, flexion in the elbow joint in an intermediate position). In each of the starting positions, first after putting on the glove, the range of passive motion in the radial-wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Eventually, they were asked to make movements as quickly and as fully as possible. Measurement of the grip force with a dynamometer was performed in both analyzed starting positions after testing the ranges of motion and speed/frequency.
The Hand Tutor device and the EH 101 electronic hand dynamometer measuring the strength of the handgrip (measurement error 0.5 kg / 1 lb) were used to test the parameters of motor coordination and grip strength. The Hand Tutor is a device with a rehabilitation program and the ability to measure the range of passive and active movement, deficits of movement (error of measurement, 5 - 10 mm) as well as the speed/frequency of movement (error of measurement, 0,5 cycle/sec.).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Masovian District
-
Warsaw, Masovian District, Polônia, 04-141
- Anna Olczak
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:: 1) patients with hemiparesis after 5 to 7 weeks after stroke; 2) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; 3) at least 40 years of age; 4) maximum 89 years of age.
-
Exclusion Criteria:1) stroke up to two weeks after the episode, 2) acute polyneuropathy and damage to peripheral nerves, 3) lack of trunk stability, 4) no wrist and hand movement, 5) hypersensitivity to electrical stimulation, 6) metal implants in the hand, cardiac dysfunction, epilepsy, 7) decorations on the fingers, 8) high or very low blood pressure, 9) dizziness , malaise of the respondents.
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: The use of the active Tip Stim device to achieve coordinated of the hand.
Influence of the tested position and the use of the active TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke.
|
The next therapy with the use of Tip Stim took place after a week.
The duration of each therapy session was 60 minutes.
After the first therapy session and after a week, the parameters of movement coordination and handgrip were examined.
The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) and lying (with stabilization), and with a different position of the examined upper limb.
The upper limb was examined in adduction, with the bent elbow joint in the intermediate position of the forearm.
In each of the starting positions, first, the range of passive motion in the wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above.
Patients were asked to make movements as quickly and as fully as possible.
Measurement of the grip force was performed after testing the ranges of motion and speed/frequency.
Outros nomes:
|
|
Comparador de Placebo: The use of the passive Tip Stim device to achieve coordinated of the hand.
Influence of the tested position and the use of the passive TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke.
|
The next therapy with the use of Tip Stim took place after a week.
The duration of each therapy session was 60 minutes.
After the first therapy session and after a week, the parameters of movement coordination and handgrip were examined.
The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) and lying (with stabilization), and with a different position of the examined upper limb.
The upper limb was examined in adduction, with the bent elbow joint in the intermediate position of the forearm.
In each of the starting positions, first, the range of passive motion in the wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above.
Patients were asked to make movements as quickly and as fully as possible.
Measurement of the grip force was performed after testing the ranges of motion and speed/frequency.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Range of passive movement of the wrist, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the range of passive movement (in mm)
|
up to 1 week
|
|
Range of active movement of the wrist, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the range of active movement (in mm)
|
up to 1 week
|
|
Wrist extension deficit, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
|
up to 1 week
|
|
Wrist flexion deficit, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
|
up to 1 week
|
|
Maximum range of wrist movement
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
|
up to 1 week
|
|
Frequncy of wrist movement (flexion to extension), cycle#sec
Prazo: up to 1 week
|
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
|
up to 1 week
|
|
Assessment of the grip strength
Prazo: up to 1 week
|
A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
|
up to 1 week
|
|
Range of passive movement of the fingers, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
|
up to 1 week
|
|
Range of active movement of the fingers, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
|
up to 1 week
|
|
Fingers extension deficit, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
|
up to 1 week
|
|
Fingers flexion deficit, mm
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
|
up to 1 week
|
|
Maximum range of fingers movement
Prazo: up to 1 week
|
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
|
up to 1 week
|
|
Frequncy of fingers movement (flexion to extension), cycle#sec
Prazo: up to 1 week
|
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
|
up to 1 week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anna Olczak, PhD, Military Institute of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 6/KRN/2019
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .